Blog

Fresh takes and insights on longtime clinical trials topics from industry experts and leaders.

Teckro's Siobhan McKenna emphasizes clinical experience as part of useful trial tech.

How Clinical Research Experience Leads to Truly Useful Trial Tech

Merging Real Experience with Clinical Trial Tech

Siobhan McKenna, Teckro clinical research manager, emphasizes the need for frontline staff experience to create genuinely useful clinical trial tech.

Teckro Clinical Research Manager Siobhan McKenna

Clinical Research Manager

Siobhan McKenna

We talk to Siobhan McKenna, Teckro clinical research manager, about harnessing the unique approach of experienced frontline clinical researchers and how this translates to functionality that truly addresses site staff needs.

The Frontline Research Experience Behind Truly Useful Clinical Trial Tech 🤓

Learn more about the real-world experiences around Teckro

The Key to Creating Clinical Trial Technology That Is Truly Useful

Clinical Research Experience and Truly Useful Clinical Trial Tech

Teckro's Rob Alves discusses prioritizing end user needs in product design.

Why Clinical Trial Technology Solutions Need Value-Led Design

Value-Led Design for Clinical Trial Technology Users

Teckro's Senior Product Designer Rob Alves discusses prioritizing the needs of end users as part of simplifying clinical trial technology.

Senior Product Designer

Rob Alves

We sat down with Teckro's Rob Alves to discuss his role as a senior product designer and why it’s important for product design to be value-led.

Clinical Trial Technology: For Real Solutions, Value-Led Design is Essential 💡🙏

Why Value-Led Design is Essential for Clinical Trial Technology Solutions

Grayson Scott from Centricity Research, describes how Teckro supports daily duties.

How Teckro Is Revolutionizing My Day Job

Teckro Personal User Case Study

Clinical research coordinator Grayson Scott explains how Teckro is easing the pressures on his daily working life and opening lines of communication between site and sponsor.

Grayson is an experienced oncology clinical research coordinator and multi-specialty supervisor overseeing various studies at multiple sites, using Teckro.

Site Supervisor at Centricity Research 

Grayson Scott

How Teckro Is Revolutionizing My Clinical Trial Day Job 📳🧡👨‍💼

As a clinical research coordinator (CRC) mainly in oncology, and a site supervisor at Centricity Research, my day job can be quite demanding, to put it mildly. Being a CRC is a “boots-on-the-ground” position. As a site supervisor, I also oversee a clinic that has eight CRCs and a variety of studies. As you can imagine, there is a breadth of technology in use for each study which can be a bit overwhelming and cause extra work! For independently owned research sites, this can be extra stressful.

I call this the “trickle-down” effect. While sponsors often have the best of intentions, by the time the effect of newly implemented technology gets down to the CRC, it can actually be harder to conduct tasks when the goal is always to make them simpler. To give an example with remote monitoring visits, a CRC must take documents that may be kept on paper at the site and redact patient health information before sending them electronically. It ends up being a lot of work – think manual page-by-page searching in the documents – despite the electronic systems that are supposed to be helping.

Instant Study Content, Even with Patients

All in all, it's rather ironic that the technology that is meant to be improving workloads and saving time is more likely to be a hindrance. It doesn’t help that common sense doesn’t necessarily prevail when it comes to the technology provided. We were once forbidden from recording patient data on paper because the eDiary system was mandatory – even though it wasn’t functioning correctly. That’s just one anecdote among many I could recount demonstrating the inconsistencies and burdens site staff can experience when it comes to carrying out their daily duties.

This is where I believe that Teckro really does make a difference. Teckro provides instant access to any of the essential study documents in your hand – the key things needed by a coordinator day to day, like inclusion and exclusion criteria.

At Centricity we are in a “hybrid mode” so to speak. We utilize electronic regulatory processes, but paper sources. This means that all the essential documents required to conduct clinical research trials are stored electronically, but the actual patient-related data is collected mostly on paper. We are eventually moving to electronic source, but right now you’d have to print off an informed consent form if you needed it.

With our essential documents (such as the study protocol) being stored electronically, Teckro makes it a breeze to review these documents. Previously, if a CRC needed to review prohibited concomitant medications, for example, they’d have to use their laptop, log in to our eRegulatory portal, and look for the protocol. With Teckro, you can just pull your phone out and search prohibited concomitant medications in the app – right there with the patient in the room. So easy!

Not only does Teckro make my day job much easier, it also opens lines of communication between sites and sponsors. It’s rare that I would speak to a sponsor as a coordinator, but it is imperative that sponsors get site feedback. Teckro allows sites to communicate in a way that they previously wouldn't have been able to, meaning sponsors can become aware of the real issues sites are having. Teckro not only facilitates this avenue of communication, but also makes it easier to communicate on-the-job.

Another advantage is the ability to negate multiple logins and URLs. As a coordinator in oncology, there are on average seven to 10 different online portals being used per study. As a coordinator, you could see 40 to 50 studies at one time – the number of URLs, passwords and usernames can be quite overwhelming. So, it’s very useful that Teckro allows us to access all content for all studies on Teckro, in one place.

Revolutionizing the Sponsor/Site Relationship

Looking to the future, I see both regulatory and source going completely electronic in the next five to 10 years. It’s been a bit of a challenge at times so far at Centricity as we’ve gone from completely paper based – so very old school – to the cutting edge of technology. This is a huge change for an independent site.

As an independent clinical research institute and network, we must do all of the leg work ourselves. If we need to implement a new piece of technology, then it is up to our own staff to learn how to use it and implement it properly. Getting the ball rolling with all this technology can be tricky, and sponsors need to work closely with sites to help build awareness and collect feedback, ensuring the solutions are helping and not hindering sites.

I am positive that Teckro can help smooth the way when it comes to not only ensuring staff have instant, convenient access to the protocol to run trials more efficiently, but also by enabling better site/sponsor relationships through seamless communication.

How a Simple App Is Revolutionizing My Clinical Trial Day Job

Guest blog: Clinical research coordinator Grayson Scott explains how Teckro is easing the pressures on his daily working life

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Research for Pregnant Patients

Aoife Delany blogs about clinical research and safe treatments during pregnancy.

Why We Need Clinical Research for Pregnant Patients

Teckro's Aoife Delany writes about the urgent need for clinical research participation among pregnant patients to ensure safe access to treatment.

Lead Clinical Information Designer

Aoife Delany

Why We Need Clinical Research for Pregnant Patients 🤰

 from the medical community to encourage the participation of pregnant and breastfeeding patients in clinical trials. Every day 12,000 newborns and 800 pregnant patients die from 

Lack of research has led to a veritable data chasm for pharmaceutical interventions during pregnancy, with only two medicines developed specifically for pregnancy related conditions in the last 

. As a result, patients and clinicians are left in limbo with limited or non-existent data to help them make important decisions regarding medications for new and pre-existing conditions during pregnancy such as 

 take at least one medication during pregnancy, often being left with no choice but to roll the dice on the potential safety risks for themselves and their unborn child.

From a historical perspective, patients assigned female at birth (AFAB) have generally been 

. Shockingly, there have even been studies specifically designed for AFAB issues that exclusively enrolled 

Male was considered the default model for clinical research, with experts citing hormonal fluctuations and their potential for drug interference as the reasoning for excluding biological women. Following the devastating birth defects caused by 

 in the 1950s and 1960s (a drug that was never tested in humans prior to rollout), a culture of protective avoidance arose to safeguard pregnant patients and gestating babies against similar outcomes in future clinical investigations.

In 1977, the Food and Drug Administration (FDA) 

 to exclude all subjects of childbearing potential from the early phases of most clinical studies to safeguard patients. These guidelines, however well intentioned, effectively sequestered pregnant patients in bubble wrap and prevented decades of vital research.

Despite this ban being ultimately reversed, clinicians are yet to truly embrace pregnant patients as potential research participants. 

 mainly focus on labor induction, abortion, and prevention of obstetric and fetal conditions, but fail to truly advance our knowledge of safe pharmacological intervention in pregnancy.

Most recently a lack of research has created a barrier in uptake of the 

 to call for greater inclusion of this cohort in clinical studies.

The medical community acknowledges that we desperately need to conduct clinical research in pregnant patients, but barriers to inclusion persist. Whilst regulatory bodies have encouraged the inclusion of pregnant patients since the 

, leaving institutional review boards (IRBs), researchers and drug companies highly hesitant.

 and compensation pay-outs for damage to the baby in utero (which have been as high as £37 million in the UK and $110 million in the US) make it extremely difficult to fund and insure studies of pregnant cohorts.

 to participate and overall distrust in the process are perhaps the most difficult barriers to surmount. The natural parental instinct to protect is unparalleled; if there is even the slightest risk to the baby, prospective parents will hesitate. Rising numbers of patients who have struggled with 

 may make patient enrolment even more difficult for fear of harm to their much longed-for baby.

Similarly, pregnant transgender and gender non-conforming patients may also be reluctant to participate due to complexities that prior 

 may pose to their pregnancy and future fertility, not to mention the well-recognized healthcare inequities experienced by those identifying within the LGBTQ+ community.

Whilst patient concerns are warranted given the mistakes of the past, obstetric research is vital to safeguard them in the future - particularly with increasing diversity in pregnant populations and new medical challenges emerging every day. Interestingly, despite participation reluctance, a 

 reported that pregnant patients and their spouses paradoxically agree that we need clinical research in pregnant populations.

So how might we attempt to overcome this impasse?

As risk insurance creates such a huge barrier to pregnancy research, efforts should be made to de-risk clinical investigations. Data from previous studies largely influences insurance rates for trials, so without a pool of pregnancy specific studies to generate data for risk assessment, premiums are likely to remain high.

 in the UK suggests short-term government partnerships to co-insure trials that generate this data pool could ultimately de-risk clinical research in pregnancy. Pediatric trials were de-risked in a similar manner following a number of initiatives to increase clinical trials in this population.

 and trial viability, insurers, sponsors, and regulatory bodies often tend to focus on fetal risk, forgetting that there are two patients in question. With risk goggles on, the potential benefits for one or both patients can be overlooked. Explicit information on how benefits outweigh risks in trial proposals needs to be prioritized to help ensure research gets the green light. This strategy was used to great effect during the pandemic in ensuring that pregnant patients were enrolled in the RECOVERY trial to find treatments for adults hospitalized with Covid-19.

Campaign for Inclusion & Research Investment

The wider research community in general does not understand the importance of including pregnant patients in trials to ensure safe access to treatment. This was especially evident during trials for the 

 – pregnant patients were excluded, but paradoxically encouraged to take the vaccine. Trials are now being conducted after rollout in this cohort.

As such, we need to properly educate researchers and clarify existing regulations to campaign for inclusion of pregnant patients in trials. Moreover, research investment in obstetrics is vital to overcoming current barriers. Currently 

 for every £1 the NHS spends on pregnancy care, only 1p is invested in related research.

We know so much about human biology, but due to this lack of research we are only at the tip of the iceberg in our understanding of reproductive physiology. Animal models are often poor, so it can be difficult to predict real world outcomes.

However, technological advances in recent years have seen, better virtual 

” which with the right investment, will allow researchers to more reliably predict the interaction of drugs across the placenta. With an effective campaign, we can incentivize research investment in this area to encourage drug companies to give attention to pregnancy specific medications.

Pregnancy is a vulnerable time, and patients are nervous for both themselves and their unborn baby. Clinical research is largely being negatively presented to them online and in the media, so their concern is understandable. However, pre-clinical research and regulations have changed dramatically since the Thalidomide tragedy, making it much easier to predict the risks that may occur during a trial.

If patients are properly engaged with and educated about the risk-benefit ratio for clinical trials, this may help reassure them and overcome their reluctance to participate. An excellent example of this can be seen in 

 where multiple clinical trials and drug investigations have been conducted in this population to prevent disease transmission during pregnancy.

 has been critical to success in HIV research. Advocates and trial participants are treated as partners in the process and not mere subject numbers on a clipboard. Patients are more far more involved in the process as a result due to increased transparency and understanding of the overall process. If we were to apply this model for all potential drug trials, patients may be far less hesitant to enroll in clinical research.

Adapt Trial Designs for Pregnant Patients

Simple modifications to trial design in non-obstetric studies may make trials more accessible for pregnant participants. The recent 

 study, exploring Staphylococcus aureus infections in the bloodstream, made specific adaptations to the randomized clinical trial protocol to enable the enrollment of pregnant patients. As this is a common peripartum infection, specialized interdisciplinary groups with expertise in pregnancy and infectious diseases were set up to formulate pregnancy specific recommendations for the trial design, including an entire appendix dedicated to pregnancy. The investigational drugs were individually assessed for safety in pregnancy and additional safety monitoring was recommended for other drugs that may interact with the liver. Pregnancy specific outcomes were also assessed in the study.

These simple modifications allowed this study to gain funding and regulatory approval for the inclusion of pregnant patients, allowing them to safely contribute to this research to improve future patient outcomes.

Protecting Pregnant Patients Through Research

All doctors take the Hippocratic oath to do no harm, but it is wrong to assume that avoiding research in pregnant patients causes no harm. While the inclusion of pregnant patients in clinical research is not without risk and should not be conducted lightly, the dangers of using medicines during pregnancy without proper investigation may pose an even greater threat. If we work together through education, research investment, trial design adaptation and engagement with patients, we can help to protect pregnant patients 

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