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Blog
Jul 08, 2020
COVID-19 Clinical Trials: News Digest
The race is on to find a COVID-19 vaccine or treatment. As a result, there are many clinical trials taking place around the world. At the same time, COVID-19 is also impacting ongoing clinical trials for other serious illnesses. This news digest includes the latest on clinical trials, both advancements to speed up COVID-19 trials and impacts of the pandemic on ongoing clinical trials. UK universities launch new COVID-19 drug testing platform. The University of Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit launched a COVID-19 drug testing platform called AGILE. It will test multiple potential therapeutics. Read the full article. UK trial begins testing second-wave COVID-19 drug from US biotech Ridgeback. Ridgeback Biotherapeutics is starting enrollment for a Phase II trial for its oral antiviral drug EIDD-2801, which will be conducted using the AGILE testing platform. Read the full article. June 2020 Running clinical trials for other drugs in the age of COVID-19. There is some evidence of recovery for clinical trials beyond COVID-19. Read the full article. Some COVID-19 trial sponsors never posted other study results in an EU database. Will they hide data again? Two-thirds of 118 COVID-19 clinical trials analyzed by the non-profit research advocacy group TranspariMED had no record of uploaded results to the European Union Drug Regulating Authorities Clinical Trials Database, though it is required under EU rules. Read the full article. MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment. UK clinical trials using hydroxychloroquine to treat or prevent COVID-19 should stop recruiting further participants, Medicines and Healthcare products Regulatory Agency (MHRA). Read the full article. COVID-19 vaccine development pipeline gears up. There are 10 COVID-19 vaccines in clinical trials. They are working at a rate that could defy usual timetables, which on average is 10 years to develop a new vaccine. Read the full article. FDA’s MyStudies app provides platform for electronic informed consent. The U.S. Food and Drug Administration is making its FDA MyStudies app available to investigators for free to obtain informed consent from patients when face-to-face contact is not possible or practical due to COVID-19. Read the full article. May 2020 How COVID-19 could improve clinical trial conduct. Sheuli Porkess Director, Research, Medical and Innovation from the Association of the British Pharmaceutical Industry talks about three areas for change with clinical trials. Read the full article. The COVID-19 pandemic and clinical trial disruptions. Nearly 70% of global clinical trials have been disrupted by enrollment suspensions, according to research. Read the full article. FDA updates COVID-19 clinical trials guidance to address serious adverse events. The FDA updated guidance for clinical trial conduct, including how and when serious adverse events should be reported. Read the full article. Institute for Advanced Clinical Trials for Children launches program to speed up COVID-19 pediatric trials. The Institute for Advanced Clinical Trials for Children (I-ACT for Children) launched the COVID-19 Emergency Access Program to speed up the development of pediatric COVID-19 trials. Read the full article. Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? Researchers will need to adjust their studies during the pandemic. Disruptions to movement and visit schedules and/or sickness or death caused by COVID-19 could impact the data of ongoing clinical trials. Read the full article.
Blog
Jul 03, 2020
No One Left Behind: Our Vision of Clinical Trial Accessibility
I’d like to take a moment to shine a humanistic light on clinical research. Good Clinical Practice sets clear standards to protect the “rights, safety and well-being of trial subjects” and ensure data quality. But the description as “trial subjects” misses the human element from the people participating in clinical research. They are mothers, fathers, sisters, brothers, sons and daughters…. Their lives and that of their families may be altered, most likely more difficult, because of their illness. Participating in a clinical trial may improve their quality of life, possibly even prolonging life. Now, let’s put a “face” to the people who seek out clinical research. If we looked at participants in clinical trials today, we would see that they generally don’t represent society, either in the composition of ethnicity or gender. And more concerning, the patients don’t necessarily represent the intended beneficiaries for the treatment being investigated.   What if we consider other characteristics of the people who could participate in clinical trials? For example, what is their level of education? What is the literacy rate? How many are hourly wage earners who don’t receive sick pay? How many have adequate – if any – medical insurance? How many live in rural or remote areas with limited medical facilities? "If we looked at participants in clinical trials today, we would see that they generally don’t represent society, either in the composition of ethnicity or gender." It is against this backdrop that we ask: how can clinical trials be more accessible to more people? This led to our recent webinar "No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation.” We oriented this session from the perspective that making clinical trials more accessible to more physicians opens opportunities to build awareness and trust among a broader patient population. In perhaps the most engaging – and entertaining – panel discussion of my career, I had the privilege to moderate a discussion with a distinguished group: Ken Getz of the Tufts Center for the Study of Drug Development (CSDD), who is a leading industry expert in clinical research trends Cassandra Smith of Janssen R&D, who is a thought leader in clinical trial diversity and inclusion Brendan Buckley, Teckro Chief Medical Officer, who is an advocate for the site perspective as an investigator/physician himself I won’t give everything away, but here are a few highlights of each presenter: Cassandra presented the case for more awareness of racial diversity in clinical trials, citing research that indicates Blacks, Asians and Latinos are underrepresented in clinical trials, making up only 24% of the participants in key clinical trials over the span of a decade. Drawing on a wealth of Tufts CSDD research, Ken painted a picture of the increased complexity of clinical trials, with 86% more endpoints and 183% increase in overall protocol data over the last 10 years. And Brendan shared his perspectives on the ethical considerations, as well as the scientific perspective that a more diverse population will improve research on how different ethnic groups may react to a given treatment. The panelists then debated a few topics in a free-form discussion: How does improving access to trials increase diversity? How can sponsors manage the potential risk associated with new research sites and/or new investigators? Given protocol complexities, how can we reduce the burden on investigative sites? How can research staff and investigators get away from referring to paper copies of the protocol or PDFs locked on their desktop computers? What will the impact of COVID-19 be on future protocol execution? As part of Teckro’s ongoing focus on clinical trial accessibility, we sponsored this webinar as a way to be a champion for those who can’t be champions for themselves. With heightened awareness of clinical research and the disproportionate impacts of COVID-19 on minority populations, now is as good a time as any for the industry to take a new approach to clinical trial participation. You can access the webinar recording in our resources center. We also published an FAQ for physicians who may consider becoming a clinical trial investigator. And we published a solution perspective on how Teckro contributes to making clinical trials more accessible.
Blog
Jun 03, 2020
Best Practices to Improve Oncology Clinical Trials: Similar Challenges for Different Sponsors
There is the old adage that the customer is always right. And to a degree that is true. But when you are trying to challenge the status quo as we are with Teckro – the way things have always been done isn’t necessarily the way they should be done. But change is not without lumps and bumps along the way. It is in my capacity as a customer success manager that I can help ease teething problems for new study teams and accelerate success for our sponsors by sharing best practices we’ve learned along the way. It is always reassuring to study teams that problems they face are problems we’ve seen and managed for other sponsors. And let’s face it, the problems with clinical trial operations are big but not insurmountable. By thinking differently, sponsors have the opportunity to make clinical trials safer, more efficient, and more effective. There is no sweeter thing in my customer success manager role than helping a sponsor achieve meaningful business results from Teckro. Solving problems in pharma comes down to changes with people and process, aided by technology. But it also requires a mindshift, which is where in my role in customer success comes in, we are helping to challenge traditional approaches to show there is a better way. "By thinking differently, sponsors have the opportunity to make clinical trials safer, more efficient, and more effective." I recently participated in a panel discussion during the Outsourcing in Clinical Trials virtual conference (of course socially distanced from my fellow presenters), and I highlighted a few categories of challenges that sponsors face when it comes to cancer trials: Keeping sites and patients engaged, especially for long studies ​ Helping research staff properly execute complex protocols ​ Protecting patient safety, particularly toxicity management This list is of course not necessarily unique to cancer, but it gave me a good platform to highlight best practices for how sponsors can approach clinical trial challenges in a way that helps all stakeholders. That’s in contrast to other software that satisfies some study stakeholders but causes others (namely sites) frustration. The example I used in the presentation was a 10-year oncology study with a large number of sites and about 4,500 patients enrolled. Keeping sites and patients engaged​. When we looked at engagement, this was a big problem for both site staff and patients. Given the study duration, there was a high rate of turnover for both CRAs and site staff. Additionally, patient visits became less regular as the trial progressed – typically every six months or so. There was a huge issue and a real concern to keep patients engaged for 10 years, especially for patients whose health outcomes were not improving. Helping research staff properly execute complex protocols. Study design complexity, particularly visit schedules, was the second area we helped the sponsor to address. Oncology trials typically have many visits​ and a very detailed list of assessments or procedures for each visit​. Add to this, there are usually a larger number of protocol amendments that include changes to visit procedures.​ For this particular sponsor, there were 6 protocol amendments in just over two years. Not surprising, sites resorted to creating cheat sheets for visits. The question was how to make it easier for research staff to execute the trial based on the current protocol. Protecting patient safety. The third challenge I discussed, which is one of the most severe on patients, was related to toxicity and safety management. The study team worried about only being reactive​ and finding out about issues after they happened​. We worked with them to gain visibility so they could potentially pre-empt AEs and SAEs​ and proactively guide site staff on how to address issues. Connecting Stakeholders, Increasing Visibility At the end of the day, it’s about visibility. We see it time and again where sponsors, monitors and sites all feel disconnected from each other. In reality, clinical trial success relies on connecting all of these stakeholders for the entire duration of a trial. Of course, a lot of emphasis is put on the initial stages and patient recruitment, but the communication and trial guidance needs to be a steady flow throughout a trial. In my customer success manager role at Teckro, I help connect these dots with proven best practices, enabled by our technology. And while the customer is always right – we are showing them a better way to move their trials into the digital age, especially now with social distancing and other COVID-19 challenges. You can view the recording of the OCT presentation on our OCT resource page. I’d love to hear from you on your thoughts on best practices – you can email me at connectwithrita@teckro.com.
Blog
May 20, 2020
Digitalization Will Improve Clinical Trial Data, a Perspective from Biostatistician Victoria Cooley
In honor of Clinical Trials Day 2020, guest blogger and biostatistician Victoria Cooley shares her perspective on clinical trial data quality and the opportunities for improvement with digitalization. From my first undergraduate course in biostatistics, I knew I wanted to pursue a career as a biostatistician. Eager to combine my passions for math and medicine, I enrolled in a graduate program for biostatistics at Columbia University. One of my first courses was an introduction to randomized clinical trials. Learning about the design and statistical aspects of clinical trials fascinated me. After all, this particular study design was considered to be the “gold standard” in research. Meaning that if properly designed, balance on baseline covariates could be achieved, eliminating the need to adjust for such confounders in the multivariable modeling phase or to have to explore other adjustment techniques. We even designed a mock phase II trial during the course. Looking back, I realize I should have included a section about the instruction of proper data collection and randomization techniques. However, no additional lectures or classroom time would prepare me for the design and analysis complexities that I would encounter in the real world as a biostatistician. Since starting my career, I have worked on the planning and analysis of a variety of observational studies as well as some clinical trials. One trial in particular stands out to me, for it challenged several of the points that I had learned in my graduate course. When the data were first sent to me, I was notified that I would need to manually exclude several patients as they were later identified as violating the randomization parameters. Some patients were randomized to the different study groups but violated the study protocol and others were screened but never randomized. From a statistician’s point of view, I could not believe that I had to discard valuable patient data from the primary analysis. As a patient myself, I would be disheartened if I found out that months or years of the collection of my data resulted in information that could not be used in the way it was intended. "From a statistician’s point of view, I could not believe that I had to discard valuable patient data from the primary analysis." As I learned more about the trial, it seemed several people had been working on the data collection and much of the data were collected on paper forms. Many papers were misplaced, and the data were collected in a scattered, disorganized manner. In order to pull the necessary data into a format for me to analyze, the investigator spent several weeks manually creating a database with all the necessary information, alongside performing their regular clinical duties. Even then, when the data were sent to me, I spent many hours cleaning and transforming the data into a format that I could work with. Despite the fact that this study was documented as a randomized clinical trial, the investigator and I still had to consider the adjustment of certain baseline characteristics in the multivariable models as we were doubtful that balance was achieved between the study groups. To complicate matters further, we were faced with a considerable amount of missing data, largely due to paper forms being misplaced or values not being entered as desired. While missing data is practically inevitable, the reason perplexed me. If the data were recorded in a different format other than on paper, perhaps digitally recorded via computer or smartphone device, it is likely that the missing data would have been far less than we observed. This is not to say that the missing data could have been eliminated completely (as some variables are inherently prone to missingness or lack of subject response), but the digitization of the recording of this data could have greatly helped. Essentially less of the data would have been “lost in translation” from paper to computer. Moreover, when data are automatically taken or recorded in real time, there are less opportunities for human data entry errors (as is the case with reading and entering information off of paper forms). The accessibility of the study protocol is another factor that could have greatly improved the success of this trial. Given that so many different people were at one point or another working on this trial, I can imagine that not everyone was completely familiar with the protocol. If the protocol were housed in some central, digital area, would the randomization parameters still have been violated? While I cannot answer this question with 100% confidence (there is always some form of doubt in statistics), I do believe that many more patients would have been randomized correctly. “If the protocol were housed in some central, digital area, would the randomization parameters still have been violated?” In case you were wondering, the trial did produce some interesting results, and after several hours of careful consideration, analysis, and discussion, our abstract was accepted at a well-regarded conference. Overall, I can say my experience working on this trial was extremely eye-opening and thought-provoking. While I am grateful for this learning experience of working on a challenging study, I do hope that clinical trials continue to become increasingly digitized in the years to come. The amount of time, effort, and money that could be saved will be worthwhile, as this will allow for more focus to be placed on saving and improving the lives of millions of people worldwide. You can connect with Victoria on LinkedIn. About Victoria Cooley Victoria Cooley is a research biostatistician in the Division of Biostatistics and Epidemiology in the Department of Population Health Sciences at Weill Cornell Medicine in New York City. She holds an M.S. in biostatistics from Columbia University, and B.S. in health science from Springfield College. Before joining Weill Cornell Medicine, Victoria worked on the analysis of clinical, molecular genetics, and biochemical data from the North American Mitochondrial Disease Consortium Registry at Columbia University Medical Center. Victoria engages in short-term and long-term biostatistical consultations for investigators. A large part of her work centers on her support to researchers through the Clinical and Translational Science Center, where she provides data analysis and prepares reports, methods sections, and analysis plans for abstracts, manuscripts, and grants. She also works closely with the Departments of Pediatrics, Urology, and the Joint Clinical Trials Office and assists in teaching biostatistical methodology to medical residents, fellows, and other research staff.
Blog
May 15, 2020
FDA, EMA Update COVID-19 Guidance for Clinical Trial Continuity
The impact of COVID-19 on non-related clinical trials is complex and poses significant challenges for sponsors, investigators, monitors and patients. With the scale of disruptions (e.g. self-isolation, travel bans) as well as the implications of social distancing, regulators are providing guidance to steer decisions that protect patient safety and preserve data integrity. Given the volatility of the situation, both the FDA and the European Medicines Agency (EMA) in conjunction with working groups from the European Commission and the national Heads of Medicines Agency (HMA) issued revised guidance from their original recommendations in late March. In particular, the FDA included a set of questions and answers that cover a wide variety of topics including: Factors sponsors should use in deciding whether to suspend or continue ongoing studies and/or initiate a new study Alternative means of distribution of investigational products. Considerations in selecting alternative laboratories or imaging centers. Remote monitoring and applying a risk-based approach to prioritize sites for remote monitoring. Usage of video conferencing between study personnel and patients.
Blog
May 08, 2020
World Ovarian Cancer Day May 8, 2020: Why Modernizing Ovarian Cancer Clinical Trials Is More Important Than Ever
Ovarian cancer has the lowest survival rate of all gynecological cancers and is characterized by its late stage diagnosis and “hidden” symptoms. By the time it is found, it has often spread, which is why it’s so important to tackle this devastating disease on all fronts. Today, May 8, is World Ovarian Cancer Day, which brings together ovarian cancer organizations around the globe to show support for the roughly 300,000 women diagnosed each year. Of this number, around 140,000 will sadly die. And by 2040, the number of women diagnosed annually will rise to 434,184. By this estimate, the number of women dying each year will increase to 293,039. Sobering statistics to say the least. COVID-19 and ovarian cancer diagnosis The problem is that these figures don’t take into account the impact of COVID-19 on cancer treatments. Right now, doctors across the world are experiencing enormous challenges when it comes to diagnosing cancer as well as treating patients. Many patients suffering with symptoms are likely staying at home. At the start of the pandemic, many governments called on physicians to halt nonessential procedures. What many people didn’t realize was that this included many cancer surgeries. So, as it stands, many women with ovarian cancer could be missing out on biopsies, scans and visits to their doctors. And because ovarian cancer is so hard to diagnose in the first place, there will be more women who will ignore early signs such as bloating and loss of appetite because they will think that physicians are not available to see them. A chance to modernize clinical trials In periods of emergency, great technological progress is often made because time is of the essence. We have seen how fast the world has got used to working from home - a development that would have been unthinkable just three months ago. The pandemic sweeping the globe has shown that people quickly adapt, and the clinical trial industry is no different. Technology solutions such as Teckro have been adopted to streamline the clinical trials management process. This is good news because technology has a role to play in improving trial efficiency, protecting patient safety and preserving data integrity – ultimately getting treatments to market faster. For patients suffering from cancers that are difficult to diagnose and/or prone to relapses, it only makes sense to remove every barrier with how clinical trials are run to focus on finding a cure. Here are two key ways to help lower the ovarian cancer fatality rate through modernizing clinical trial management: Improve communication among research staff, monitors and sponsors. By connecting stakeholders, it means everyone has the most current study information. Whether specific details in the protocol or providing clarifications for a site-specific question, collaboration and real-time communication are essential. As they say, information is power. In clinical trials, information is the key to trial safety and data integrity. We have found that when research site staff have access to immediate, accurate answers, there are fewer errors and the right patients are recruited faster. For example, in our analysis of several studies with a Top 10 sponsor, we found that sites searching with Teckro randomized on average 55% more patients compared with sites not on Teckro. And two oncology trials with a Top 10 sponsor reported 55% fewer deviations per patient randomized for sites searching with Teckro compared with those not. Increase the number of women taking part in clinical trials. The Every Woman Study Summary Report from 2018 that surveyed 1500 women worldwide, showed that fewer than one in four women were asked about joining a clinical trial. But, just 2.7% of women said that they were not interested in taking part in future clinical trials, with eight in 10 women saying they would be willing to travel to another hospital to take part in a trial. The results clearly showed that the desire is there and the opportunity more often than not, is not. By making clinical trials simpler, more accessible and more transparent, our hope is that more investigators will want to run trials and that will in turn make trials more accessible to more patients – including women. Ovarian cancer is a devastating disease with more than 80% of ovarian cancer patients experiencing a relapse and over half dying in less than five years post-diagnosis. The survival rate is well below that of other cancers affecting women, like breast cancer which has a 90% five-year survival rate if caught early. There’s no doubt that at the moment the long-term projections look bleak for ovarian cancer. However, it doesn’t have to be this way. This year, World Ovarian Cancer Day falls during a time when COVID-19 has also highlighted the vulnerability of cancer patients when resources are scarce. This offers an opportunity to seize the chance to modernize clinical trials to make sure that effective treatments can be discovered and that ovarian cancer patients can access them and don’t slip through the cracks during the eligibility process. Want to learn more about how Teckro is helping to accelerate cancer trials? Join our presentation on May 27 at 16:30 during the Outsourcing in Clinical Trials Virtual Conference. More details can be found on our events page.  
Press Coverage
May 06, 2020
Irish Tech in Use in COVID-19 Drug Trials
Blog
Apr 28, 2020
Product Development - Ant Steps or Giant Leaps?
There is something intrinsically romantic and inspiring when a remarkable individual, or team, have a sudden moment of magical genius and creativity, resulting in a new technical invention to improve the current “best in class.” These stories are memorable and make great Hollywood movie scripts. But in reality, product development is quite often very different, something Kevin Ashton discusses in his book How to Fly a Horse. Rather than through a eureka moment of inspiration, new creations, inventions or discoveries are the result of many small, incremental steps. Continuous, and sometimes endless, loops of “try-assess-adjust” activities are undertaken by common individuals who have abundant grit to persist despite missteps along the way. There are many thought-provoking points in Ashton’s classic. However, the timeless idea of delivering great innovative products as a sequence of continuous “ant-size” iterations rather than the result of infrequent giant leaps is even more relevant today in the world affected by coronavirus – the black swan of 2020. The word “continuous” is frequently used in business context. Quality managers discuss continuous improvement process. Product and software managers explore continuous product delivery. And more technically-minded folks consider continuous integration as one of the “must-have” engineering practices. Continuous improvement is a mindset. It is any effort to improve products, services or processes in an incremental fashion or as a “breakthrough.” It originated in Japan after World War II and is how Toyota expanded from a small local car-maker to the largest automobile manufacturer in the world. Today, the concept of continuous improvement widely applies to business practices, including the International Organization for Standardization of a Quality Management System (ISO 9001:2015) and an Information Security Management System (ISO 27001:2005). Continuous improvement ideas are also at the core of agile software development. So, how do we apply “ant steps” innovation to product development in the highly regulated clinical trial market? There is no silver bullet or “one size fits all” approach, but there are a few universal ideas to stay nimble and deliver business value via continuous product delivery. Document your software development lifecycle (SDLC). This should encompass all essential phases for software delivery, from initial discovery to detailed user requirements through to development, testing and deployment. Scrum framework is a good starting point, but it needs to be applied appropriately and customized to support your own specific business needs, team skills and experience. For example, if your software product has regulatory implications and computer system validation is required, you may need to accommodate validation activities from the beginning into your sprint cycle. Focus improvements on the big wins. Starting with a well thought out and relevant SDLC is important, but what is even more important is to keep your continuous improvement hat on at all times. Consider that you are only as good as your last product delivery cycle. Think of your SDLC as a mini management system, ensuring that you have adequate performance metrics so you can spend your improvement efforts on the right areas – the big wins. Adopt an agile mindset. People are the lifeblood of any organization. The Agile Manifesto acknowledges this in the first value – “Individuals and interactions over processes and tools.” A highly motivated team equipped with basic tools or informal, high-level processes is more likely to outperform a demotivated team with the best tools or detailed procedures. You will need to hire for and constantly nurture your organizational agile mindset to succeed in continuous delivery cycles. Measure your progress. Mid- and long-term, strategic product roadmap planning is critical. Without a plan in place, you may become very efficient in churning product enhancements that contribute very little business value or don’t address real user needs. And, along the way, you may lose sight of what your product needs to stay competitive. At regular intervals, you need to measure business value against financial metrics, user feedback, and alignment with your roadmap. Ideally, this analysis should be a quarterly exercise and include all C-level and founders if they are still actively involved in the business. Learn early and continuously. Common wisdom is to deliver a minimal viable product (MVP) as quickly as possible to obtain real user feedback and ensure the “right” product is being built. A team practicing Scrum may assign MVP features to sprints and deliver an internal release at the end of each sprint. However, these internal releases are not always treated with the same level of rigor as production releases. The result is that key learnings may only be acquired very late when the first release to production takes place. Alistair Cockburn, one of the initial authors of the Agile Manifesto, describes it as “Big-Bang Design.” This approach is riddled with problems and risks, including descoped MVPs being released behind schedule. Continuous product development is a mindset – it’s a journey and not a destination. It is also a multi-dimensional topic. For example, I haven’t even addressed the topic of good engineering practices, which are critical to continuous product delivery. While COVID-19 has disrupted everyone at some level, it shouldn’t be a roadblock to continuous product development. Rather, it is a time to find strength – both as individuals and teams – to overcome obstacles. This applies to software development and any other passion we have in life. For example, a few days ago, I had the opportunity to listen to Patrick Mouratoglou, a world-renowned tennis coach, speaking to students of his tennis academy on a video call. He had a very powerful message to his students – some of whom are likely to be future professional athletes. Despite lockdown, Patrick told them that professional players stick to their daily routine as much as possible to continue to make ant-size improvements in their game. Whether tennis, software development or something else, continual improvement comes with thousands of ant steps. I would like to hear your thoughts. Please email me at connectwithjacek@teckro.com.
Blog
Apr 16, 2020
COVID-19: In This Brave New World It’s Time to Overcome Fear of Clinical Trial Technology
It's not an exaggeration to say that the pharma industry must operate at a pace that it’s never seen before to tame or even cure COVID-19. As billions of people live in some kind of lockdown, countries, businesses, and society in general cannot endure this kind of restriction indefinitely. And healthcare services – already stretched – cannot continue to operate under this heavy load. While we are resilient in the face of previously unthinkable situations, there needs to be a light at the end of the tunnel. Government leaders have a heavy burden to make the right decision of when to loosen or lift restrictions. And so, it is now that the pharma industry must step up to swiftly find a way to help us through COVID-19 and protect us in the future. In the “old world” -- before COVID-19 – it could take a decade for a new vaccine to come to market. Now, we are all counting on the industry to deliver treatment in months – something unthinkable before the year 2020. Traditional clinical trial timetables must be accelerated – safely accelerated – as the world waits for a solution. It’s with this speed that clinical trial technology can help pharma to truly transform. And it’s for this reason that Teckro is already supporting 5 COVID-19 trials with more on the horizon as sponsors race to safely set up COVID-19 trials. A stark reality has become evident: namely that clinical trial technology is not a “nice to have” but a “must have.” In previous articles I’ve discussed the paper protocol and how both inaccessibility and inconvenience of paper places an unnecessary burden on site staff and physicians. Before, during and after clinical trials, many questions need to be answered, such as which patients are eligible, which trials are suitable, how to manage a toxicity that arises, etc. The current environment creates all sorts of new dilemmas, meaning that it’s more important than ever that those involved use clinical trial technology. Here’s why: Rethinking Clinical Trials Social distancing isn’t exactly compatible with clinical trials. This is where rethinking how to best conduct the trials comes in. The issue is that there’s a fear of the unknown when it comes to conducting trials from a virtual or decentrialized setting. Data concerns, privacy worries and a very human suspicion of change have all been factors blocking change. Well, it could be that soon there’ll no longer be a choice. It may be difficult at first, but ultimately rethinking how clinical trial technology can open the door for greater diversity, with more underrepresented populations taking part. The time of travel to sites meant that those from more remote communities and women (who often have childcare responsibilities as well) haven’t been able to participate as much in the past. If this period of global standstill could be used to test out decentrialized clinical trials, they could well become commonplace in the future. This is good news for society because decentrialized clinical trials means more convenience and more diversity, which will ensure better drug development outcomes. Real-time Information The clinical trial protocol and other study documents when accessed through binders of paper are generally nowhere near the patient. If there is an adverse event and people are working from home, interaction costs could increase as no one will know how to access the information they need or even who has it! Real time communication can help to streamline discussions between site staff, CRAs and Sponsors, as well as help physicians make quick decisions. In the months ahead, real time communication will not be a luxury but a necessity to guide clinical trial safety and data integrity. In today’s reality, clinical trial technology is the only reasonable means to achieve real-time and yet still compliant communication. No Need to Travel! The pandemic has made us all rethink our priorities and discover what’s really necessary in the world of work. Some meetings and travel have proved to be superfluous, with videoconferencing doing the job just as well. The way clinical trials are structured, there are monitors across multiple sites, with each one potentially having a study coordinator trying to reach the CRA to interpret something in the protocol. The problem is that the CRA could well be travelling to the next site and unable to give the information needed, slowing down the whole communication process and potentially hindering the sites. In turn, Sponsors have limited real-time visibility into the clinical trials especially at the site level. By removing this friction, Sponsors can access site-level information to address issues hindering sites. As travel isn’t currently an option for anyone at the moment, it’s a chance to test clinical trial technology that allows staff to communicate in real time. Now Is the Time to Overcome Fear of Clinical Trial Technology There’s now a globally disrupted workforce and the clinical trial model needs to keep pace with this changing reality. After all, who knows what type of world will emerge in the next few years? The need for transparency, connectivity and mobile access to the protocol anytime, anywhere for all research staff is a necessity. And now, more than ever, the industry must get over the fear of clinical trial technology to adapt to the new reality. Do you have any thoughts on how clinical trials can embrace technology? As always, I'd love to hear from you. Please send your thoughts to connectwithgary@teckro.com
Blog
Apr 01, 2020
Taking a Risk-Based Strategy Further: It’s Time to Rethink Clinical Trial Monitoring
There probably isn’t a person on this planet that isn’t closely watching the current coronavirus (COVID-19) pandemic. Like everyone, I am concerned with the health of my family, our employees, our customers, and generally the people of the world impacted by this virus. But it is in the face of such adversity that we need to ask how we can adapt for whatever uncertainty the future holds. If anything is certain, it is that there will be circumstances that will disrupt business as usual. Disruption happens. Businesses need to be prepared for these disruptions and many have business continuity strategies currently in place. But, who could have predicted a global pandemic which has impacted every business sector and supply chain? Answer: No one. Clinical trials are vital for evaluating and advancing medical and patient care. Today’s current situation is impacting how these clinical trials can continue operating safely and efficiently. Functions impacted include – but are not limited to – supply chain, patient safety, data integrity, patient retention, investigational product management, clinical trial monitoring and trial management in general. All areas in clinical trial management have been impacted but specific to clinical trial monitoring, the current model must be modified to ensure that the clinical trials can continue to operate. Specifically, clinical trial monitoring must be adapted to ensure a risk-based strategy is implemented to manage all study-related risks but also to ensure that patient safety is addressed and that data integrity is maintained. Here are a few observations in the current clinical trial monitoring model that need to be reconsidered in light of our current situation: Clinical trial monitoring is primarily based on physical movement of people. CRAs are moving from site to site. You only need a few flight disruptions and cancellations to cause issues. And now, CRAs are likely not able to perform site visits due the coronavirus restrictions. It can be retrospective and reactive. CRAs can only be at one place at a time. As a result, there is no real-time detection of site related issues. It might not be until the next site visit weeks later that potential risks are identified. It can separate research staff and critical medical/scientific knowledge. In most instances, the CRAs are the intermediaries between research staff and trial management and medical monitors. This “switchboard” means providing study related answers can take precious time that no one can afford. In the current environment, quick and real-time communication is essential to ensure continuity of care. It is dependent on paper. This requires that site staff physically refer to the regulatory binder for protocol-specific information. How will regulatory documents be accessed for verification if CRAs or site staff are not physically located on site? Specifically related to the protocol for quick reference, how will sites be ensured that they are utilizing the most current version available? In consideration of the current circumstances and to bring us forward in confronting the current monitoring limitations, it is time to rethink the approach to monitoring and bring it into the 21st Century. We can help. Here are some targeted solutions that I think can realistically improve the effectiveness of monitoring and address the inevitability of disruptions that will happen in the future: Rely less on face-to-face interactions. Utilizing a risk-based approach, CRAs will only be on-site to address any critical milestones and will have more time and bandwidth to assess critical to quality endpoints in-house rather than onsite. Streamline communication with research sites. CRAs and clinical trial management should have a proactive, simple and streamlined way to provide real-time updates rather than generic or passive means (e.g. in person visits, email, newsletters, etc.). This includes proactive information on study updates as well as answers to time sensitive questions. Measure the impact of the communication. Hope isn’t a strategy. When it comes to knowing whether study-related information has been effectively delivered and received and being actioned by the target audience, there is no room for guessing whether the PI or study coordinator got the message. Respond quickly to data that shows potential risk to the study. With less physical travel, CRAs can review data remotely in real time and respond to critical data points that are negatively trending and represent a risk to the study. In this model, we can further improve the quality of the trials and better protect patient safety. Have immediate access to the current protocol any time. Research staff and CRAs always need access to the right version of the protocol at their fingertips. This isn’t always practical or efficient with paper or PDFs in a portal. But real-time access to the right version at the right time is vital. Out of any crisis, there is an opportunity to reflect on how we can better prepare for the future. We’ve seen how important it is to continually evaluate new ways of operating in light of this current situation. With the management of clinical trials, there are numerous strategies to be considered. Specific to monitoring clinical trials, it’s time to rethink the current model. Fortunately, with the smart use of technology, it is not out of reach to make changes in how clinical trials are monitored and we are well-positioned to rise up and meet the challenges imposed by COVID-19 and its impact to the management of clinical trials. What do you think about modernizing clinical trial monitoring? Please send me your thoughts at connectwithandrea@teckro.com
Blog
Mar 24, 2020
A Letter from Our CEO: Supporting Your Clinical Trials Without Interruption During COVID-19 Crisis
I would like to assure all of our clients that Teckro is well prepared to support your clinical trials, in spite of the COVID-19 pandemic. I understand that you are challenged with restricted movement of CRAs and patients, and that research staff are under pressure to treat those afflicted with the coronavirus (COVID-19). You can be rest assured that Teckro will do everything in our power to support your trials without interruption. Whether you have protocol amendments, need to change user access, or have users who need support from our helpdesk, our staff will be available. At Teckro, we have reviewed our existing pandemic plan, and we are updating as necessary. Like everyone, we are closely monitoring advice from local health and government authorities in all of the countries where we have staff. We have a dedicated task force that meets daily to plan and assign actions and to keep senior leadership current on any developments.   As with many businesses, we have taken the precaution to suspend all non-essential travel. Our global staff are working remotely from their homes until April 10, at which point we will reassess the situation. To preserve business continuity, we have core teams identified as well as second-in-command personnel for major functions, should the need arise.  From a product standpoint, Teckro software is built on a hybrid infrastructure between top-tier Equinix data center and AWS. Our Equinix-based infrastructure is fully redundant on each layer starting from power, connectivity, and throughout the application and database layers. Our AWS-based infrastructure is deployed across three availability zones for high redundancy. Teckro has robust DR procedures to allow a move from Equinix to AWS as required, which is tested on a regular basis. This is a global crisis that knows no boundaries of nations, races or beliefs. United as one, we will overcome this situation. I hope that you, your families and your employees stay in good health. If there is anything I or my staff can do to help you at this time, please don’t hesitate to contact us. Best regards, Gary This letter was originally published on March 12 and has been revised on March 24. Updates will be published here as necessary to provide current, ongoing information for our customers and business partners.
Blog
Mar 08, 2020
International Women’s Day 2020: We Must Demand More Gender Diversity in Clinical Trials
In the first of our series on clinical trials and diversity, our CEO Gary Hughes discussed how ethnic populations are underrepresented in trials, leading to a lack of knowledge around how drugs affect patient groups viewed as outside the “norm” (today still primarily white and male).  On International Women’s Day I’d like to draw attention to that other neglected cohort: women. As roughly 50% of the population, we’re hardly in the minority, which is why it’s so shocking that women’s health is so under-researched.  Women’s lack of participation in clinical trials is not a new problem. A recent study from the Allen Institute for Artificial Intelligence in Seattle examined women’s participation in medical research over a quarter of a century, looking at 13,000 trials registered on clinicaltrials.net. While women made up 49% of all participants, when the data was analysed study by study, women were often still unrepresented. For many disease types, the ratio of females to males didn’t match the real-world gender split among patients. This included deadly conditions such as cardiovascular disease and chronic kidney disease. 
Blog
Feb 28, 2020
We Cannot Afford to Ignore the Lack of Ethnic Diversity in Clinical Trials
The importance of diversity in clinical trials cannot be emphasized enough – yet progress isn’t being made nearly as quickly as needed. Recent research shows that the levels of patients enrolling in a clinical trial as a first form of treatment for cancer in the US is just 0.1% and this is predominantly made up of White men with private insurance. A ProPublica analysis found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of Black patients were enrolled. Yet, African Americans make up 13.4% of the US population. Sadly, these statistics don’t surprise me. Ethnic groups have been underrepresented for as long as I can remember. This is a huge problem. Drugs can work differently depending on factors like sex or ethnicity, meaning people from different ethnic groups and genders may respond in hugely different ways to the same drug. But if there’s a lack of diversity in clinical trials, how will we ever know? Stand Up to Cancer Moves to Make Trials More Diverse Here at Teckro, our machine learning platform is used by more than 7,000 oncology sites worldwide and I recently wrote about Teckro’s goal to revolutionize clinical trials to help beat cancer on World Cancer Day. Therefore, I welcomed the news that Stand Up To Cancer (SU2C) have announced a ground-breaking new initiative to increase ethnic representation in clinical trials. All future SU2C-supported grant proposals will now be required to address how the research will consider ethnic diversity when it comes to recruiting and retaining patients. The move comes just a few months after the FDA announced a new focus on enhancing clinical trial diversity. These bold new developments force us in the industry to adapt, learn best practices and work to ensure the clinical trial population is a true representation of society. After all, diversity is crucial for safer, more effective medicines, so that researchers, regulatory bodies and patients are confident that a drug or therapy will reach the communities they’ll serve best. Here are a few more suggestions I have to help make clinical trials more ethnically diverse: Make participation easier. Currently time and travel commitments mean that taking part in trials is difficult for participants. By making trials more accessible, it will be easier to recruit from a wider variety of backgrounds. By using digital and virtual clinical trials, patients located further afield could be reached and the burden could be minimized by conducting some aspects of the trial remotely. Wearables, smartphones and tablets could also make participation more convenient. Build trust. For more ethnic communities to be engaged in clinical research, there needs to be improved relationship building and a better sense of partnership. Patients need to trust the research process, as well as the healthcare professionals involved and – it should go without saying - be treated with respect for their role in the trial. This can be achieved by having specific teams from local communities onsite to understand cultural sensitivities. As a result, more diverse clinical research communities will be built, leading to a more varied pool of participants. Improve awareness. Many potential participants don’t even know that clinical trials exist! The research community could change this by reaching out to local physicians to increase awareness of clinical trials. Resources could be provided to help them discuss the benefits with patients. In my previous blogs, I’ve mentioned how important it is to make the clinical trial process more convenient for physicians. And because physicians are typically short on time, they may not even be that knowledgeable about clinical trials themselves. Which brings me on to my final point… Increase education. Driving better understanding of clinical trials is an essential element when it comes to participation from a wider group. Providing proper education (using culturally appropriate materials) is a way to assist further understanding. And this goes beyond physicians handing out a few leaflets, ideally there would be strong local publicity campaigns – even nationwide conversations about the importance of ethnic diversity in clinical trials. Ambitious? Definitely. But a future of safer drugs, more efficient medication and lives saved, is one worth fighting for. Do you have any further thoughts on advancing clinical trial diversity? I’d like to hear them, please email me: connectwithgary@teckro.com.
Press Coverage
Feb 27, 2020
What Does the Future Hold for Clinical Trial Recruitment?
Blog
Feb 04, 2020
World Cancer Day 2020: Progress Has Been Made - But We Can Do Better
World Cancer Day is a chance for global communities to unite, to show solidarity and pledge to work together to defeat this devastating disease. It’s also an opportunity to celebrate – we know more about cancer than ever before thanks to incredible breakthroughs in new medicines, advances in surgery and increasing scientific knowledge. The American Cancer Society has reported that cancer death rates in the United States alone fell 2.2% from 2016 to 2017 – that’s the largest single-year decline in cancer mortality ever reported. And cervical cancer could be eliminated by the end of this century, according to The Lancet, if cervical screening and HPV vaccination programs are scaled-up to 80% -100 % coverage over the next 50 years.  On one hand the decline can be linked to lifestyle changes, with smoking cessation contributing to the drop in the cancer mortality rate - lung cancer accounts for nearly one-quarter of all cancer deaths. But improved cancer detection tools such as new imaging technologies and less invasive surgical approaches have also played their roles. The official World Cancer Day site estimates that up to 3.7 million lives could be saved each year by mobilizing resources for prevention, early detection and treatment. Teckro’s Message on World Cancer Day, February 4, 2020  While we celebrate the breakthroughs made so far, the truth is that millions of people across the world will continue to die from cancer because new medicines are taking too long to get to market. Also, more than half of doctors who run their first clinical trials will never run another, meaning that patients’ access to trials are limited and therefore, so is the search for a cure. This is why our message on World Cancer Day 2020 is that we can do better. Much better. Clinical trials are stuck in another time, the burden on investigators and trial sites is increasing – which is quite extraordinary considering this technological era when we’re all so obsessed with speed and instant results! The cumbersome nature of the protocol puts physicians off participating and slows down progress when it comes to defeating serious diseases like cancer.  We’re proud that Teckro is leading the way in changing this reality. Our machine learning platform is currently being used to support more than 7,100 oncology research sites around the world. An impressive 77% percent of registered users are active on the platform ­– and it’s not required, so they are consciously choosing to use Teckro because the platform brings so much value to them.
Blog
Jan 28, 2020
Overcoming Fear of the Unknown: The Path to Virtual Clinical Trials
Recently, I attended a seminar on virtual clinical trials. I know, I know…another seminar to enlighten us on what’s new, upcoming, and trending. With benefits like reduced costs and saved time, virtual clinical trials seem appealing. So, why aren’t sponsor companies and clinical research organizations (CROs) running to implement them? Those of us who have worked in the pharma industry for quite some time understand that while new technology might sound promising, there are real challenges with its implementation. If we are being honest about why virtual clinical trials are not being implemented as quickly as you would expect, the truth – at least in part — is fear of the unknown. Let’s face it, trying to change years of clinical trial conduct is like turning the Titanic on a dime. Process changes, organizational mindset, regulatory requirements, data privacy concerns, and impacts on other internal systems are just a few reasons why virtual clinical trials haven’t taken off. So how do we challenge our current system and take that first step into this unknown space – or at the very least, dip our toes into the big scary pond that is virtual clinical trials? The bigger question in my mind is, can we as an industry afford not to? We only need to take a look at the current state of clinical research trials to see how broken they are. With an approximate 30% patient drop-out rate and 50% of sites not recruiting as per schedule, it’s clear we need to tackle the root causes for continuous trial delays. There is also a lack of trial diversity. Specifically, the women, elderly and individuals in rural populations who are woefully underrepresented. Throw in some additional barriers like patient mistrust making recruitment more difficult, and it’s not hard to see that we have a real problem. Given these glaring statistics, we need to ask how can virtual clinical trials improve the current state of the industry? There are instances where some are already dipping into the virtual clinical trial space, especially in late-phase trials. But we need a push to take the ultimate plunge within the Phase I-III space. That push is coming directly from the patients, and their voices are getting understandably louder. Let’s discuss removing these barriers to get into the virtual clinical trial game. Here are a few checklist suggestions to start the discussion: Take a holistic approach. Whatever technology is being considered must be harmonized across all devices. As an example, the smartphone plays an essential role. It can be used for patient engagement, medical reminders, phone/telemedicine options, patient eDiary, and follow-ups. Consider what data you need. An app alone can only solve one part of the problem. Data needs to be enabled within the app, which means the level of information captured is crucial. As an example, capture only what is vital for an endpoint of the study ­­– any additional information will complicate the study by requiring additional regulatory hurdles, incurring data reliability issues, data overload or resistance from patients and healthcare providers. Fit into the everyday life of the user. Technology should not be a burden for the patient or healthcare professional. For example, instead of having to manually track and enter data could the patient use a wearable device that would automatically and easily capture the required information? Plan for changes. Another consideration is to evaluate what would happen if there is a change in the technology itself. If there are routine software changes, will the data remain viable? Consider how this will be managed. Factor in compliance. Finally, compliance is key! Consider compliance with actually wearing the device or using the technology. Again, this needs to fit seamlessly into their day to day life. The good news is that sponsors and CROs don’t have to go it alone. There are existing resources out there that can offer assistance for evaluating new technology. And the FDA has existing guidance to help ensure the appropriate regulations are being followed. We are on the cusp of transforming how we conduct clinical trials. Yes, there are regulations and challenges, but even the FDA is on board and encouraging greater adoption of clinical tools. Our collective job now is to take the leap and be the innovative change agents that move the industry forward. Do you have any suggestions on how to improve industry adoption for modern technology like virtual clinical trials? Please email me at connectwithandrea@teckro.com.
Blog
Dec 18, 2019
The Secret to Clinical Trial Success: Unblocking Research Staff
There aren’t enough physicians in the world taking part in clinical trials. But what’s more troubling is that a large percentage of doctors who run their first clinical trial say they wouldn’t run a second one.  Physicians are the trusted advisor to patients. Without increased participation from them, it limits access to clinical trials for patients. Rather than trying to skirt the problem, we need to address core issues that limit why doctors don’t want to run clinical trials. Reducing Interaction Costs  Doctors generally have just a few minutes with each patient. This means they have a very short window to make critical decisions about the patient’s eligibility for a clinical trial. For larger research centers, this decision can be even more difficult if they are running several trials for different sponsors in the same disease area.  Given time pressures, logically speaking, it would make sense that doctors have quick and easy access to the information they need when they are with the patient.  Yet, access to the clinical trial protocol and other study documents today is primarily through binders of paper documents that are nowhere near the patient. Or, there may be electronic versions of the same documents that are hosted on a secure password-protected portal.  Neither approach is ideal for busy, time crunched research staff on the go. The reality is that high interaction costs – the time and effort to find answers – can limit trial success if it’s just too hard to find the information to make the right decisions.  Unblocking Research Sites Whether clarifying inclusion/exclusion criteria, managing a toxicity, or confirming the next steps from an adverse event, research staff will have questions that require input from experts. Sometimes the answers are time sensitive.  With so many channels – email, phone, text, chat – it’s hard to keep track for both CRAs and research staff. Email still seems to be the dominant channel, but it lacks any urgency for immediate questions.  Additionally, informing research staff of study or document changes is not straightforward as different sites may be on different versions of the protocol and located around the world. Newsletters are an effort to tackle some of the challenges, but that is still a generic, one-way broadcast. It is no surprise that communication is a common complaint among research staff. Without timely, accurate answers, sites are blocked. If sites are blocked, trials are blocked.   Considering the Research Site Viewpoint  Research staff have the best insights when it comes to patients. It is a wasted opportunity not giving them a voice with regards to things such as whether a trial should progress to the next phase or the viability of finding patients for a given study.  By asking for research site feedback, sponsors can gain valuable field-level intelligence that can influence trial success and future study design. Who better to give input than those who know the patients best?  Let’s not forget that investigators and research nurses are human. Asking for feedback has the potential for sponsors to foster better relationships with research staff. This in turn could make them the sponsor of choice and ensure that clinics want to manage their trials.  Giving Research Staff Confidence  It all comes down to confidence. Research staff need to have confidence they are making the best choices for their patients.  As the front line in any clinical trial, we need more doctors engaged. Giving them the tools they need to make informed decisions at each step could reduce friction for sites. And with more doctors participating, more patients will have the opportunity to participate in clinical trials.  This would be a win for everyone. Do you agree? Please let me know at connectwithgary@teckro.com.
Press Release
Nov 25, 2019
Teckro Adds New Products Following Sky-High User Adoption
Meet Teckro: the machine-learning platform revolutionizing the way clinical trials are run.
Press Coverage
Nov 21, 2019
Limerick-based Healthcare Startup Given Major Boost
Blog
Nov 19, 2019
The Trouble with Clinical Trials: Getting Rid of Zombies
New medicines are becoming increasingly complex to develop. As a result, clinical development is taking 25% longer and the chance of a new medicinal product getting market approval is half of what it was a decade ago. Much of this is reflected in the way clinical trials are performed, with a 10% annual increase in the number and variety of procedures required. Thus, the burden on investigators and trial sites is steadily becoming heavier. In most aspects of our lives, the internet has enabled us to rapidly access information. In particular, smartphones allow us to search and retrieve almost any information that we need “on the fly.” We book our flights and hotels, make restaurant reservations and communicate with our families on our phones. Who uses, or even possesses, a telephone directory anymore? However, a zombie-like relic of the telephone directory still lives on in clinical trials. It’s called the protocol, which: Is almost always a weighty document of perhaps 150 densely printed pages. Must only be used in its currently approved version, so it may need to be changed half a dozen times during the life of a trial. Each amendment must be approved for every individual site. Usually lives on a shelf in an office, often remote from where it is most needed in the clinical area in which its trial is being conducted. Is slow to search for information, especially if not immediately to hand. If it does have an electronic existence, it is usually as a PDF document which is hard to search in a hurry. The protocol hasn’t changed in any significant way for 40 years. It is no surprise that about 35% of adverse findings of FDA inspections are related to non-compliance with the protocol. This is not a harmless zombie! There are many examples to illustrate why printed protocols have outlived their utility. For example, typical oncology sites outside of the major centers may run about a dozen different trials at one time. It is a big ask to expect an investigator to remember the detailed inclusion and exclusion criteria for each one when they sit in-clinic seeing their patients. Their time constraints mean that they have only a few minutes to consider whether any patient in particular might qualify for one of these trials. They are unlikely to rummage through a dozen protocols to check. They may refer to a “cheat sheet” with the criteria listed. Are they sure it’s from the current protocol version? It’s easier to procrastinate and move along to the next patient waiting in line outside their office. Another possible trial participant misses out. Another example illustrates how adverse effects don’t respect office hours. Consider the following scenario. Its 8 p.m. on a Friday. A study coordinator in an Immuno-oncology study is about to sit down to dinner in a restaurant. A study participant phones urgently to report sudden onset bloody diarrhea and is desperate to know what to do. The protocol copy is two miles away. How will the coordinator instruct the participant exactly according to protocol? Do we expect them to recall precisely what the protocol says, or will they set off to consult it? Or will they just try to remember and hope that they are correct? It is vital that the right advice is given if the safety of the participant and the integrity of the trial are to be preserved. To effectively deal with the many weaknesses of relying on printed protocols that live on office shelves, we need to bring the whole process into the 21st century. Just as we have with almost all ways that we seek and find information in every other aspect of our lives. Do you have any other examples of how today’s paper protocol hinders clinical trial success? I’d like to hear them – you can email me at connectwithbrendan@teckro.com.
Blog
Nov 14, 2019
#WorldDiabetesDay: How Clinical Research Is Revolutionizing Diabetes Treatment
Someone dies from diabetes every 8 seconds. The number of adults with diabetes has doubled in the past three decades, according to the World Health Organization. On World Diabetes Day, we'd like to highlight the importance of clinical trials for diabetic patients. Clinical research has revolutionized the treatment of diabetes. Prior to 1921 diabetes was akin to a death sentence, until Banting and Best isolated insulin for injection. Originally extracted from cows and pigs, clinical researchers went on to develop synthetic insulin by modifying bacteria to mass-produce insulin in the lab during the 1980s. Clinical trials conducted during the 1950s gave us oral hypoglycemic agents for the treatment of type 2 diabetes. In recent years, there have been a number of exciting new developments in diabetes research: Glucose Monitoring Tattoos: Scientists at Harvard and MIT are currently exploring the possibility of using tattoos to detect changes in blood sugar, reducing the need for finger-prick tests. Traditional ink would be replaced by fluorescent biosensors that change color in response to high or low blood sugar. Insulin Patches: Recently, insulin patches for the treatment of diabetes have emerged from clinical trials. Insulin is delivered via a patch applied to the skin (like nicotine or contraceptive patches), removing the need to directly inject insulin. A recent study found that the patch is just as effective as insulin pens while providing a preferable delivery alternative for patients and clinicians. Light-Activated Insulin Producing Cells: Researchers at Tufts University have recently transplanted engineered beta cells (insulin-producing cells of the pancreas) into diabetic mice. When exposed to light, these cells produced 2x to 3x the normal amount of insulin, allowing glucose levels to be controlled without the need for drug intervention. New Drug Targets: Most recent of these innovations is the identification of the biological mechanism through which a rare mutation in the SLC30A8 gene can protect against the development of type 2 diabetes. This gene is involved in zinc transport in the body, which is important for insulin secretion. Now that we know how the mutation acts, this research potentially gives us a new target for future anti-diabetic and preventative therapies. As the exact cause of type 1 diabetes remains unknown, clinical research is vital. It will allow researchers to compare and contrast patient blood glucose levels, track metabolism, monitor organ functionality in relation to medications, shape the improvement of current treatments, bring new treatments to fruition, and perhaps one day, develop a cure. Have thoughts about how clinical trials can help with the treatment of diabetes? Please email connectwithaoife@teckro.com, I'd love to hear from you!
Press Coverage
Jul 23, 2019
Why Putting Design at the Heart of a Company Can Help it Thrive
Press Coverage
Jul 18, 2019
Teckro Announces 45 Dublin Jobs as it Expands Engineering Hub
Press Coverage
Jul 05, 2019
Teckro CEO Gary Hughes’ Appetite For Disruption
Press Coverage
Jul 02, 2019
Teckro Hiring Spree Nets Ex-Icon CMO
Press Coverage
Apr 01, 2019
Alphabet and Apple Take Divergent Paths in Health
Press Coverage
Feb 14, 2019
Limerick-based Teckro Raises $25m in Funding