Clara MacKay
CEO, World Ovarian Cancer Coalition

2020 was a difficult year - to put it mildly! If you had told me this time last year that our lives would be so thoroughly disrupted, with work, schools and social lives all moving online, I would have found it hard to believe. The novel coronavirus, COVID-19, has changed everything so dramatically and we have not yet come out of the other side of the chaos.

But despite the gloom, there is much to be hopeful for in 2021 and beyond. The world’s most talented scientists collaborated to develop vaccines at record speed. Science and technology have shown us what is truly possible. I am proud to be part of the clinical trials industry that has helped facilitate this incredible story of human ingenuity.

As a result of the disruption, the world is keenly focusing on clinical trials. Those working in the industry are not used to the limelight. They work hard quietly in the background to keep trials running so drugs can get to market and lives can be saved. 

But in the last year, clinical trials have gone from being an abstract idea of how drugs are developed, to a key factor in how people can protect themselves, their families and get back to normal life. 

And what we have seen has been extraordinary. The Pfizer-BioNTech vaccine, first fast-tracked for emergency use in the UK in early December and followed swiftly by the US and Europe, represents a breakthrough scientific achievement to fight this devastating pandemic. The Moderna vaccine, which uses the same mRNA technology as the Pfizer vaccine, has been approved in the US and the EU. As well as this, the Oxford-AstraZeneca vaccine is being rolled out in the UK as I speak, with the first person vaccinated in the first week of this year.

I am optimistic that the situation will look different by summer 2021 and that what we have learned as an industry from COVID-19 will have positive consequences for society.

In 2020 we have seen how successfully the human race can work effectively together to accomplish big goals for humanity. Goals that previously didn’t seem possible. From vaccine researchers, to the amazing medical staff on the ground, everyone has played their role. Here at Teckro we also did our bit supporting drug trials to help find treatments for COVID-19. And we will continue in our mission to help the world recover from this difficult period by supporting clinical trials success.

So, there is much to be thankful for and much to look forward to. Here are four reasons to be optimistic for the clinical trials industry in 2021 and beyond:

1. COVID-19 has proved that vaccines can be developed at record speed

Initially, scientists were careful not to promise quick results when it came to developing a vaccine. There was much speculation around the idea of a vaccine being discovered so fast – in an industry where the process is complicated and safety is paramount.

Vaccines have eradicated many deadly illnesses throughout history, from mumps to smallpox and polio, and have greatly increased the average life expectancy. Prior to COVID-19, the fastest a vaccine had ever been developed from early sampling to approval was four years – the mumps vaccine in the early 1960s. In contrast, an AIDS vaccine is still not available after 30-plus years of effort.

Luckily, history was made. The world collectively breathed a sigh of relief. The news of the Pfizer-BioNTech vaccine was announced early November. The vaccine took just 10 months to follow the same steps that normally take 10 years.

But this achievement goes beyond COVID-19. The fact that a vaccine has been developed at record speed, bodes well for the future of vaccines, drugs and treatments. I predict we will see profound cultural and practical changes in the way companies approach the clinical trials process and what they deem possible. This has the potential to save many more lives across the globe.

2. Clinical trials will make greater use of technology to get studies back on track

When the pandemic hit, many clinical trials were forced to stop. Some trials were too complicated to continue without the physical presence of patients and staff such as oncology trials. But other trials were able to continue by adapting to new ways of working. Sponsors moved at hyper speed to make the most of solutions such as decentralized trials, wearable technologies and real-time communications technology.

The pharmaceutical industry has been slow to adapt to the modern age, but COVID-19 has sped the process up. This lag of uptake happened despite the modernization of ICH Good Clinical Practice (GCP), with the introduction of ICH E6 (R2) which required sponsors and CROs to implement a more robust risk management process.

The aim was to make sure clinical teams applied critical thinking lessons learned from previous trials. The technology was available to enable this approach, but full industry adoption was still too slow. 

Now it seems that pharmaceutical and biotech companies have discovered what many other industries already knew - that there are huge advantages to utilizing technology – which can be used to optimize clinical trials, leading to greater safety, efficiency and data integrity. I am optimistic we will see companies continue to adopt new solutions at pace in 2021 and beyond – and it’s about time, too.

3. Technology means we will see greater diversity 

Statistics show that ethnic populations in the US made up of Blacks, Asians and Latinos, represented just a quarter of trial participants over 10 years. This urgently needs to change and technology can help by bringing communities closer together.

As discussed above, the rapid uptake of technology will lead to smoother relationships between stakeholders working in the clinical trials industry as communication and efficiency are improved. The same can happen in local communities. Strengthening connections between participants, community HCPs and research sites on the ground can improve diversity by building trust with underrepresented groups. And solutions such as decentralized trials can make it easier for them to access trials, as they won’t have to travel, or lose out on work.

Ironically, technology can help to “humanize” the clinical trials process, with stronger ties at a local level helping to bridge the gap between ethnic minorities and clinical trials.  

4. There will be greater data transparency in the clinical trials process

COVID-19 has shown the necessity for data transparency when it comes to expediting the drug development process. Regulators need data to make informed decisions about which treatments and drugs they will approve and why. Decisions need to be made that are supported by the data, which should be available to healthcare professionals and the general public.

This may sound obvious, but access to the right information increases trust – which is crucial to ensure uptake of vaccines and treatments to fight the pandemic. Research in 2020 showed that sponsor organizations continue to miss reporting deadlines for publishing results within one year after a study has finished. This lack of openness must and will change.

After all, COVID-19 has changed the game, with the European Medicine Agency (EMA) deciding to publish clinical data for COVID-19 medicines, such as the authorization of Veklury (remdesivir). The EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force. 

Data visibility needs to be built into the entire process of clinical trials, not just the reporting of completed trials. This is why we founded Teckro, clinical research should be simpler and easy to access. Today, data openness is no longer a nice-to-have, but a must-have and I predict that the pandemic will kickstart a new trend with greater data transparency. This means that the whole research community as well as the public can remain involved and informed when new drugs, treatments and vaccines are developed and approved. 

Teckro came into existence in 2015. Five years connecting all clinical study stakeholders with the answers they need and of working hard together to achieve our goals. Like everyone else, we have had to adapt to new working practices this year to ensure we all remain safe and secure. It has been a huge learning curve for us, with our team emerging stronger than ever. For this, I am incredibly proud.

Our purpose to modernize clinical trials is now needed more than ever. The situation is urgent and while the industry has adapted successfully during the pandemic, the challenge is to continue this in the future. The good news is that we have seen the best of humanity working together to find a solution to the chaos unleashed on the world and the industry has made huge leaps forward. 

The future is bright and moving into 2021 and beyond I am optimistic that the clinical trials industry will be transformed and fit for the modern era. Here at Teckro, our mission is to support clinical trials stakeholders across the board and to save more lives by speeding up drug development. I have faith we will succeed and am looking forward to the year ahead – it will be a good one!  

Teckro CEO Gary Hughes gives four reasons to be optimistic for clinical trials in 2021 and beyond

Four Reasons to Be Optimistic for Clinical Trials in 2021 | Teckro

Looking Forward to 2021 and Beyond: Four Reasons to be Optimistic for the Clinical Trials Industry 

This is the second part in the Quality by Design blog series.

In the first part of this blog series about Quality by Design, I wrote about how we have seen an increase in the uptake of new technologies by sponsors and clinical research organizations (CROs) to effectively manage clinical trial conduct during the pandemic. 

To address and adapt to the changing clinical trial management landscape, sponsors, site management organizations and CROs are maximizing their focus by utilizing a risk-based management approach and incorporating the Quality by Design (QbD) principles as outlined in ICH E6 R2.

Incorporating these principles will help facilitate efficient and effective trial management. And, most importantly, it will ensure that the safety and well-being of patients is prioritized, as well as preserving overall data quality.

There are numerous benefits to clinical trials from this targeted and systematic approach to continuously evaluating risks. Specifically more informed communication among stakeholders. At the end of the day, this approach helps all functional teams throughout the stages of the clinical trial, from patient recruitment, study start-up, study conduct, through to study closeout. And the right technology can help expedite the risk-based study management and monitoring process.

In my previous blog I discussed how risk-based thinking can be broken down into two main aspects: defining what is critical to success for the study and continuously assessing and managing the risks that could derail that success. 

Essentially, this requires early detection and visibility into the status of those risks so that sponsors and clinical trial teams can proactively mitigate any negatively trending delta  changes.

While the concepts of early detection and visibility sound obvious, these are not new ideas. Metrics and key performance indicators have been around for quite some time now.  However, consider the fact that there still exists no way of seeing in real-time what sites are doing. Nor can sponsors or monitors see what documents site personnel are accessing to get them the right information quickly.

Also consider the fact that there are numerous channels to communicate important study related updates, medically related questions, or clarifications for the study teams or medical monitors. The “old ways” still exist when it comes to inefficiencies. This includes the fact that sites are still using paper documents and protocols, that there are multiple communication pathways, and delayed responses to research staff questions due to study teams traveling or important information getting caught up in emails.

These examples demonstrate that there is still room for improvement in the visibility and detectability sector of proactive trial management. Teckro’s digital engagement platform is perfectly positioned to help study teams facilitate the QbD and risk management principles previously mentioned. Teckro offers greater insight into the site behaviors, which could have a direct impact on study trial efficiencies and ultimately, trial outcomes. 

Quality by Design and the Teckro Digital Engagement Platform

Let’s take a deeper dive into how Teckro’s unique features support risk-based monitoring and enable the QbD process:

Teckro Search – Get the answer any time on any device

As the protocol “in your pocket,” Teckro means that the latest trial instruction is always available for research personnel from their mobile device. This eliminates guesswork for research staff by putting the protocol within reach at the point of care. And it helps study teams manage risk because essential study information is readily accessible for those making key decisions, such as participant eligibility and toxicity management. 

Stakeholders access current clinical trial information instantly with Teckro Search. The word current is key because we always keep the right, approved version of the protocol for each site. This avoids the risk of protocol deviations or violations because site staff are following the wrong version of the protocol.  

But this isn’t merely for the convenience of site staff. Sure, they get the benefit of anywhere, anytime access to the protocol and other study information. However, the benefits are far greater in that sponsors now have the visibility they truly need to understand at a site level what is happening with their trials. What sites are looking at the protocol is a good indication of engagement. And search trends are a critical early indicator of potential safety issues. 

Teckro Connect – Bypass multiple communication channels 

Teckro Connect allows site staff to directly access experts for immediate clarification or guidance. This takes the pressure off busy CRAs and means that staff on the ground can confirm the right course of action, making trials more efficient and improving patient safety.

Real-time access to experts also helps time-pressured physicians. As the trusted advisors to patients, they are key to ensuring successful patient recruitment. By unblocking research sites, physicians can quickly and easily confirm decisions, for example patient eligibility. 

The combination of Teckro Search and Teckro Connect is powerful from a risk management perspective. It means site staff have not only the access to critical study information when and where they need it, they also have a direct line to ask further clarifying questions – all from their mobile phone. This means questions are answered at the point of care with a patient. Coming back to the QbD principle of continual review, now sponsors have visibility into site staff questions so they can spot trends and be proactive with issues.  

Teckro Engage delivers relevant, timely updates to the right people at the right time. While Teckro Connect is a way for site staff to request help, Teckro Engage is the means by which study teams can delivered targeted messages with relevant updates or essential guidance. 

Busy monitors and research staff are alerted and can see all of their important study updates in one place through Teckro, rather than wading through emails. From a risk management perspective, having this message history all in one place ensures a seamless chain of communication across study team members so there is a record of messages and when they were sent.

The other benefit of Teckro Engage is that study teams can track whether their messages are opened. We all know that even with the best intentions, emails can slip past us and pile up in our inbox. The Teckro Engage dashboard means study team members don’t have to guess whether their messages are being received. 

Teckro Survey – Drive study improvements 

Teckro Survey is a web-based tool that makes it quick and easy for study teams to get direct feedback from research staff and monitors on the ground.

Risk can be managed with targeted surveys capturing time sensitive site feedback. Study design can be improved by capturing the input from research sites. This way, performance can be improved upon and the site viewpoint included when it comes to determining the feasibility of the next phase of a trial. 

Just like with Teckro Engage, study team members have a dashboard to track open and response rates to their surveys. Again, this takes the guesswork out of whether the message is received. Now, study team members have ways between Teckro Engage and Teckro Survey to be super targeted on the messages they want to send and the feedback they collect for continual improvement and risk-based monitoring. 

A 21st Century Approach to Clinical Trials 

Risk-based study management requires that all study stakeholders take responsibility in order for the trial to be successful.  Teckro’s digital engagement platform helps to enable sponsors and clinical research teams  “bake in” quality principles from study award through to study closeout.

By evaluating, managing, revising and communicating risks often and defining what is critical to success up front, study teams can expect improved study-related efficiencies, reductions in protocol deviations, and improved communications with study teams and site staff.  

Adopting new technologies to meet the new requirements for study management and monitoring doesn’t  have to be overly complicated.  Optimizing clinical trials using Teckro can help pave the path forward for clinical teams and bring clinical trials firmly into the 21st century.

Find out how to improve risk management for your clinical trials with Teckro. Book a demo with our experts!

In the second part of this blog series, Andrea Parish looks at how Teckro enables quality by design for clinical trials

How Teckro Enables Quality by Design | Teckro

How Teckro Enables a “Quality by Design” Approach to Clinical Trials

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. 

FDA issues emergency use authorization for first COVID-19 vaccine. The emergency use authorization allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the US. Read more.

Johnson & Johnson trims the size of its Phase III COVID-19 vaccine trial. The decrease from 60,000 to 40,000 participants is due to the surge of COVID-19 cases across the US. Read more.

Sanofi suffers major setback in development of a COVID-19 vaccine. The problem relates to inadequate results in older adults, which the company traced back to an inadequate formulation of the vaccine, Su-Peing Ng, global medical head for Sanofi Vaccines said in an interview. Read more.

Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19. UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. Read the news.

EMA publishes safety monitoring plan and guidance on risk management for COVID-19 vaccines. The plan is to ensure that all new information collected post-marketing will be promptly reviewed and any emerging new information will be shared with the public in a timely manner. Read more.

Pfizer and BioNTech conclude Phase III study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Read more.

Moderna COVID-19 vaccine candidate meets primary efficacy endpoint. The Phase III study of mRNA-1273 met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%. Read more. 

FDA authorizes monoclonal antibody for treatment of COVID-19. The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. The EUA was issued to Eli Lilly. Read the details. 

Novavax COVID-19 vaccine granted fast track designation by FDA. Novavax announced that the FDA has granted Fast Track Designation for NVX-CoV2373, the company’s COVID-19 vaccine candidate. The company expects to begin its pivotal Phase III clinical trial in the United States and Mexico by the end of November. Read more.

EMA implements extra transparency measures for COVID-19 vaccines and therapeutics. The European Medicines Agency (EMA) has published clinical data in support of the authorization of Veklury (remdesivir) and information on COVID-19 treatments and vaccines that have received scientific advice or informal guidance from its pandemic task force. Read the article.

FDA approves first treatment for COVID-19. The US FDA approved antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Read the article.

Eli Lilly pauses trial of antibody drug over safety concern. The ACTIV-3 clinical trial is paused because of a safety concern. Read the article.

J&J pauses coronavirus vaccine trials due to unexplained illness. Johnson & Johnson said the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians. Read the article.

EMA starts second rolling review, this time for Pfizer COVID-19 vaccine. The European Medicines Agency's human medicines committee (CHMP) has started a "rolling review" of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read the details.

FDA publishes vaccine rules. The FDA released new safety standard for COVID-19 vaccines, with guidance that vaccine makers should follow clinical trial participants for at least two months to rule out safety issues before seeking emergency use authorization for a vaccine. Read the article.

FDA reshuffles priorities to meet COVID-19 trial demand. The sudden influx of COVID-19 trials work at the FDA has required pulling resources from various departments at the agency to support the efforts. Read the article.

Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data. Lilly submitted an initial request for emergency use authorization for its antibody treatment, specifically for higher-risk patients who have been recently diagnosed with mild to moderate COVID-19. Read the article.

GSK and Vir to expand COVID-19 antibody treatment study. GSK and Vir Biotechnology are set to globally expand the study of experimental antibody VIR-7831 for the early treatment of COVID-19 patients with a high risk of hospitalization to Phase III. Read the article.

How research nurses and midwives are supporting COVID-19 clinical trials in the UK. Clinical research nurses and midwives have been central to the rapid implementation of COVID-19 clinical trials. Read the article. 

EMA begins real-time review of AstraZeneca’s COVID-19 vaccine. The European Medicines Agency initiated the first "rolling review" of a COVID-19 vaccine developed by AstraZeneca and the University of Oxford. Read the article.

Pfizer follows Moderna in releasing COVID-19 vaccine study protocol. Protocols are typically kept under wraps until studies are complete, but Pfizer and Moderna have made their SARS-CoV-2 trial protocols public in a transparency push. Read the article.

First patient in OSCAR trial receives GSK’s otilimab in UK. The Manchester University NHS Foundation Trust in the UK has said that the first patient in the OSCAR clinical trial received GSK’s investigational drug otilimab to treat severe lung disease related to COVID-19. Read the article.

Johnson & Johnson’s single-dose COVID-19 vaccine generates strong immune response, early data shows. The company released positive interim results of its Phase I/IIa study. It has moved into a Phase III trial that will enroll up to 60,000 volunteers across three continents. Read the article.

Older people likely to be underrepresented in COVID-19 trials.  A study published in JAMA Internal Medicine concludes that despite the fact that people over 65 are disproportionately impacted by COVID-19, they are underrepresented in the clinical trials. Read the article.

Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance. Investigators should review and report AEs and SAEs, according to updated FDA guidance. Read the full article.

Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial. The companies have submitted an amended protocol to expand the enrollment of their Phase III pivotal COVID-19 vaccine trial to up to 44,000 participants. Read more.

UK’s MHRA allows restart of Oxford/AstraZeneca COVID-19 vaccine trials. The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the Oxford/AstraZeneca COVID-19 vaccine candidate are safe to resume. The late-stage trials were paused after a participant in the UK study experienced an unexplained illness. Read the full article.

Biopharma leaders unite to stand with science. Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. Read the pledge. 

Sanofi and GSK move COVID-19 vaccine into human trials. Sanofi and GSK are launching a large Phase I/II clinical trial at 11 sites across the US, initially enrolling 400 people. This candidate is the first outside of China to use a vaccine approach for which there is already a licensed vaccine. Read the full article.

Sanofi says Kevzara drug fails as possible COVID-19 treatment. The international Phase III clinical trials of Kevzara didn't meet primary or secondary endpoints and as a result trials will be stopped. Read the full article.

Phase III clinical testing of AstraZeneca COVID-19 vaccine candidate begins. A multi-site, Phase III clinical trial for AZD1222 has begun. The trial will enroll 30,000 adult volunteers at 80 sites in the US. Read more.

Translate Bio, Sanofi COVID-19 vaccine proves promising in animal studies. Experimental COVID-19 vaccine induced immune responses in animal studies. The companies plan to start human trials in November. Read the full article.

COVID-19 and readjusting clinical trials. The disruptions from the pandemic are numerous, but there are some reasons to be optimistic about changes with clinical trials, according to the Lancet. Read the full article. 

COVID-19 clinical trials must append more diversity, researchers assert. Researchers raise concerns about the lack of diversity in COVID-19 clinical trials. Read the full article.

Disruptions to global oncology trials have fallen to a three-month low. Cancer trials disrupted by COVID-19 are resuming faster than other therapeutic areas. Read the full analysis. 

FDA Coronavirus Treatment Acceleration Program (CTAP) dashboard. This dashboard provides updates specifically on therapeutics (not vaccines or devices). View dashboard.

Many early COVID-19 studies have low-quality design, risk low-value evidence, research finds. The researchers estimated that only about 29% of studies would produce data strong enough to potentially inform changes in clinical care. Read the full article. 

US biotech uses AI to pick antiviral for COVID-19 trial. US biotech AI Therapeutics begins a Phase II trial of its LAM-002A, an antiviral drug. The company develops drugs identified with a proprietary artificial intelligence (AI) algorithm. Read the full article.

"Promising" data on Oxford/AZ coronavirus vaccines. Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus. Read the full article. 

Moderna COVID-19 vaccine candidate has positive results in all participants in Phase I trial.  Moderna published interim analysis of the open-label Phase 1 study of mRNA-1273 in the New England Journal of Medicine. A Phase III trial is expected to start later in July. Read the report.

NIH launches trials network for COVID-19 vaccines and therapies. The COVID-19 Prevention Trials Network (COVPN) is expected to operate more than 100 trial sites across the US and internationally. The first Phase III trial conducted  is expected to be Moderna’s mRNA-1273 vaccine. Read the full article.

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. 

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.

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.

This Teckro news digest includes updates on COVID-19 clinical research and also impacts of the pandemic other ongoing clinical trials.

This is the first part in a Quality by Design blog series, exploring the key principles of quality by design.  

One of the major barriers facing clinical trials is poor trial design, which can lead to incomplete data sets, an expensive trial process, and ultimately contribute to a trial’s failure.

This is why drug developers and CROs are focusing on risk-based monitoring, utilizing the quality by design principles as outlined in ICH E6 R2, a 2016 update to the Good Clinical Practice Guidelines. 

The revisions in the amendment mainly affect sponsors, stipulating a more proactive approach to study design, risk management and study monitoring. Currently sponsors conduct multi-site international clinical trials, but repeating trials in different markets to comply with different regulations is inefficient and leads to delays in delivering new drugs to patients.

By “baking” quality into the process, trials can be continually monitored to achieve optimization; this standardization leads to greater efficiency.

We’ve all seen just how much the world has changed over the last six months. The pandemic has upended our way of life and many trials have been cancelled or delayed. The benefits of improving trial design cannot be overstated!

First things first, let’s look at the main reasons for low quality trials:

Lack of protocol clarity leading to poor understanding of what is required

Lack of management supervision or quality control of required tasks during the study

Reduced quality control over collection and recording of study data

Problems with patient recruitment, enrollment and retention

Clinical trial quality relies on having an investigational plan with solid objectives and outcome measures. Quality by Design (QbD) emphasizes building quality into the process from the beginning. 

Initially introduced in the early 1990s, the approach focuses on identifying Critical to Quality (CTQ) key data and trial processes. By understanding the factors that are CTQ, risks can be managed effectively. 

QbD allows for risk and knowledge-based decisions and continuous improvement. It is a systematic approach to development that starts with predefined objectives and emphasizes product and process understanding and control, based on sound science and quality risk management.

Risk-based thinking can be broken down into two main aspects: 

Defining what is critical to success. What matters most? Patient safety and data reliability are crucial.

Managing the elements of the clinical trial.  It is vital to continually evaluate, control, communicate, review and report risks.

So, how can we ensure success when combining these two concepts?  

Study set-up is key. Setting the team up for success begins with identifying what is critical to succeed along with processes that have an impact on patient safety and data reliability.  This requires a rigorous review of the protocol by cross-functional teams. In addition, it's vital that key critical to quality indicators are developed with the appropriate thresholds identified as early as possible.  De-risking the protocol incorporates the quality by design philosophy and ensures risk is managed proactively.  

Continuously review the study. Once the risks have been identified and CTQ indicators with thresholds have been established, the process needs to be managed. Utilizing the QbD approach requires a continuous review of the study throughout the study lifecycle. 

One method of doing this is by using the four-step management method used in business - PLAN, DO, CHECK, ACT – or PDCA cycle method. PDCA is an iterative four-stage approach to improve processes, products and services in order to resolve problems. It was originally developed by renowned management consultant Dr. William Edwards Deming in the 1950s. 

His focus was on identifying what caused products to fail to meet customer expectations and predicting the results of an improvement effort, by constantly comparing results to revise the theory. This very practical approach is used today to help businesses develop hypotheses about what needs to change and test them in a continuous feedback loop.

Let’s take a closer look at how the PDCA cycle can be used to improve QbD in clinical trials:

Risk Management: Everyone’s Responsibility

This risk management process requires that every department and individual must be responsible for the delivery of the product – in this case the clinical trial. Here are a few ideas on how to do this:

Manage customer’s expectations early.  This involves asking the right questions, such as what does success look like?  Understanding this will enable the team to create a systematic process to build in quality that will enable the task to be more achievable.  If quality is ignored, this result will be much more costly than evaluating on an ongoing basis.  

Utilize best practices and lessons learned to avoid similar issues throughout the study.  These reviews highlight issues that have occurred, the root causes of these issues, and the actions that were implemented to resolve the issue.  Why not draw upon these experiences to avoid the same?  

Risk management throughout the study is vital. This will ensure that the pre-identified risks are monitored and managed with expediency.  Also, this is a continual process, and the risks can change during the study.  Quality needs to be managed at a micro-level and early detection is priority.  

Communicate clearly and often. Transparency allows for issues to be addressed thoughtfully and thoroughly.  This way, clinical teams can avoid miscommunication and delayed resolutions to tackle issues.  

In the wake of the pandemic, trial quality is going to be of utmost importance to help clinical trials get back on track. We have seen considerable improvement when it comes to the uptake of new technologies in order to manage trials during the pandemic, solutions which can help expediate risk-based management processes. 

But it’s important not to get complacent because there is still a long way to go. Despite the introduction of the ICH E6 R2 amendment in 2016, just 18% of new studies applied a risk-based approach to monitoring that very same year. Although this improved by 2018, jumping to 61%, industry-wide adoption has been slow to date. And even though clinical trials are modernizing due to the restrictions ushered in by the pandemic, old habits die hard.  

However, I remain optimistic. I believe the years ahead will see a rush to implement Quality by Design into clinical trials because COVID-19 has been a wake-up call for the industry. We can no longer ignore the pressing need to build quality into the clinical trials process. 

This is the first part in a Quality by Design blog series.  The second part will look at how Teckro can help sponsors and monitors with risk management in their clinical trials. 

In this blog series, Andrea Parish looks at the principles of quality by design for clinical trials to optimize monitoring and improve efficiency.

Quality by Design for Clinical Trials | Teckro

How Quality by Design Can Help Pave the Path Forward for Clinical Trials in a Post-COVID World

There is a gap in clinical trial communication. In fact, it is a chasm separating those conducting research and those with study expertise.  

Considering how hard it is to execute clinical trials today, logic would say that sponsors and CROs should do everything in their power to make it as easy as possible for research staff to ask questions or clarify their interpretation of protocol instruction. 

But until now it’s been hard work for investigators and site staff to get in touch with study experts. Depending on the urgency, they may call, email or use some other non-compliant communication app to reach their main point of contact, often a study monitor. This then kicks off either a game of telephone or an email loop, neither of which are designed for expedited answers. 

If you’ve ever played the “game of telephone” as a team building exercise, it is interesting how the fidelity of the message degrades as it passes from person to person. What it shows is the farther away from the source, the less accurately information is conveyed. 

Generally, it isn’t something malicious – it’s just the nature of how communication flows. For example, if you have limited knowledge on the subject, you may not be equipped to completely and accurately relay the information. Or you might be distracted during the conversation so that you may not capture the entire story.  In turn, what you convey downstream is not quite complete. 

Email is better served as a channel to inform than it is to resolve time sensitive queries.  Depending on the number of forwards and how long it takes for the information to make its way along a chain of people, it could be too late or even outdated by the time it reaches the intended recipient.

Additionally, email can be open to misinterpretation. For example, we may be unintentionally biased in reading what we think the email says, instead of what it actually says. This could lead to a mismatch of the answer sent back that is not actually to the original question. And If further clarification is needed, the whole email thread kicks off again.

When we look at clinical trials, particularly when physicians and research staff need time sensitive answers, the way communication is handled today is akin to the game of telephone or the email loop. Simply put: neither are fit for purpose.   

That is why we are introducing Teckro Connect. 

Teckro Connect puts the power directly in the hands of research site staff to ask questions of study experts. It sits within our digital engagement suite, so the user can switch from a keyword search to requesting medical advice – all within Teckro. And it is compliant with industry regulations, including 21 CFR Part 11. 

Let’s take the example of a doctor who is with a participant and needs an immediate answer related to dose modification. I’ll contrast the “old way” and the new way with Teckro Connect. 

In the old way, the doctor would email or phone the clinical research associate (CRA) who in turn would forward the query on to the medical monitor. Given the best-case scenario, this answer will take several minutes or hours – maybe longer. 

With Teckro Connect, the doctor takes out a mobile phone and starts a conversation with a dedicated group of experts who are assigned by the study team. This means the physician has qualified people on the other end of the conversation who are capable of providing immediate guidance. Directing a question to a team will speed time to resolution. The first team member who sees the question can jump in and answer. 

In the old way, if the email loop is just between the CRA and the medical monitor, knowledge from other specialists won’t surface because they aren’t part of the email chain. And after all of that waiting, what happens if the physician has a follow up question? The email loop starts all over again. 

With Teckro Connect, responses are visible to the entire group so that other experts can add to the conversation. This thread also allows the doctor to ask any further clarifying questions to fully confirm the best decision. In the end when the query is fully answered, the exchange is marked resolved and the conversation can be exported for inclusion as trial reporting documentation. 

In the old way, what happens if the original person the CRA tries to reach is out of the office or unavailable? With Teckro Connect, this is irrelevant because the dedicated group is managed so that no one contact is a single point of failure. And if one person is switched out for another specialist due to holiday, reassignment, etc., the communication thread continues on. This means site staff don’t need to maintain an up-to-date list of contacts. One less thing for them to worry about. 

In the old way, emails could be shared or exported to be included in reports. But this is a rearview mirror of the exchange, meaning no real action can be taken because of the questions. Rather, the document is simply reflecting that there was a question and how it was answered. 

With Teckro Connect, there is so much more intelligence to be gained not just knowing that there was a question but understanding the substance of the question. Additionally, study teams will gain value from spotting trends if the same questions are popping up over and over. It could mean there is a need to clarify something in the study documentation – or it could be an early indication of a safety issue. Either way, knowing when you can still take action is immensely powerful for our sponsors. 

Expanding Digital Engagement with Teckro 

We’ve now added real-time guidance with Teckro Connect to our digital engagement platform. Let’s look at how Teckro Connect complements the other capabilities of Teckro:

Self-Service Answers with Teckro Search. With so much information at our fingertips, we are conditioned to find our own answers. Google has done a brilliant job -  all we need to do is “Google” the answer. I will say that for us at Teckro, this makes our job easier for training users. If you have a clinical trial question, all you have to do is “Teckro” the answer. Our interface gives a nice, familiar search bar to type in questions; answers are instantly retrieved from the protocol and study information. But what happens when self-service answers aren’t enough? 

Real-time Guidance with Teckro Connect. When research staff need quick answers or clarifications from something they read with Teckro Search, Teckro Connect gives them the ability to directly ask the experts. 

Proactive Outreach with Teckro Engage. There are times study teams want to send specific alerts or updates to certain sites or certain people. It could be they are seeing a pattern in either the search terms from Teckro Search or the same questions are coming through Teckro Connect. With Teckro Engage, study teams can direct relevant messages to keep sites updated or give timely advice. 

Site Feedback with Teckro Survey. Study teams can quickly set up Teckro Survey to gauge site sentiment. For example, we recently had a sponsor who used Teckro Survey to assess whether sites could use their telemedicine to resume recruitment following COVID-19 disruptions. With Teckro Survey, they got direct site feedback to inform their decision. You can read more in a case study. 

Built-in Visibility Across the Teckro platform, we provide visibility that study teams need to understand site engagement. From which sites are actively searching with Teckro Search to which of the Teckro Engage messages are being opened and read, study teams gain insights so they can measure effectiveness.

In our quest to make clinical trials simpler, more accessible and transparent, Teckro Connect is an important addition to our product family. Good communication is the cure to many problems; disconnected communication is the source of much frustration. 

You can find out more about Teckro Connect in a few different ways: 

View the Infographic: Connecting Research Staff Directly with Experts

Teckro Connect is a new approach to clinical trial communications for research staff to directly reach study experts.

Introducing Teckro Connect: Clinical Trial Communication in the Hands of Research Staff

At the heart of it, clinical trials are about data. By testing treatments and drugs, researchers seek to measure how well they work and quantify possible side effects. Regulators need data to make informed decisions about which treatments and drugs they will approve – and for what specific indications. 

As we are all acutely aware, researchers around the world are working on COVID-19 treatments to lessen the severity if you get the virus and vaccines to put an end to the pandemic. In this extraordinary time, everyone is trying to move quickly. But even if time is of the essence, we need to balance safety with speed. There’s just too much at stake to rush decisions that aren’t supported by data. And the data should be transparent so healthcare professionals and the public in general have access.  

At the risk of stating the obvious: clinical trial data needs to be made available sooner rather than later.

In a positive step for data transparency, the European Medicine Agency (EMA) decided to publish clinical data for COVID-19 medicines. The first results published were the data that supported the authorization of Veklury (remdesivir). EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force.  

Data sharing means that the whole research community can be involved. This can be especially useful when pandemics occur. For example, during the Ebola epidemic six years ago, data sharing meant that the virus was rapidly able to be controlled. Additionally, research duplication can be reduced when resources are pooled through data sharing.

Expectations for Publishing Clinical Trial Results 

As it stands, FDA rules require clinical trial sponsors to post results to Clinicaltrials.gov one year after a study has finished. Yet, research earlier this year from Science shows that sponsor organizations continue to miss the reporting deadline.

Some have downplayed concerns about missing deadlines for ClinicalTrials.gov, saying that instead researchers, doctors, and patients can learn about trial outcomes from peer-reviewed publications. But the reality is that thousands of trials are never published, particularly when treatments are found not to be effective. 

Over the last few years, we have seen efforts to tackle the missing data. For example in 2013, The BMJ announced that it would “no longer publish any trial of drugs or devices where the authors did not commit to making the relevant anonymized patient level data available, on reasonable request.” 

And in February 2020, hundreds of universities, drug companies and medical device manufacturers were ordered by a federal judge in New York to post missing trial data for trials conducted on drugs and devices over the last 10 years. 

Building Transparency into Clinical Trial Process

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Every clinical trial starts with a question