Contributed Commentary By Tom Lemberg

August 25, 2021 | The COVID-19 pandemic illustrated an unfortunate reality that the healthcare industry has long tolerated: The industry’s traditional model for clinical trials represents a limited model for medical research. Conventional trials are costly, slow, and limit the diversity and number of eligible patients who can viably participate, often stifling the research that they are intended to promote. However, decentralized clinical trials (DCTs), which leverage technology to collect patient data remotely, have recently begun to change the industry by helping to increase trial access and participant diversity. As DCTs continue to evolve, we have learned that technology can allow us to bring research into almost any clinical setting. In fact, patients can even identify trials, and bring their own physician on board to administer most of the necessary care to participate; a concept I like to call Bring Your Own Physician (BYOP). 

Abrupt Switch to Patient-Centric Decentralized Clinical Trials

Last year, the FDA issued  guidance encouraging CROs, PIs, and sponsors to alter their clinical trials so that they could effectively navigate the challenges presented by the pandemic. Some trials that started as centralized became DCTs, making the process more patient-centric. The industry quickly learned that the recruitment, diversity and speed benefits of the DCT approach were very compelling and the evolution of how we deliver clinical research was at hand. The FDA continues to support this guidance today. 

The volume of DCTs is expected to explode in the coming years, as demonstrated by two McKinsey surveys that captured the dramatic shift in attitudes by pharmaceutical companies and contract research organizations (CROs) toward virtual clinical trials. In December 2019, 38% said they expected virtual trials to be a major component of their portfolios, and 48% expected to run a trial with most activities conducted in participants’ homes. However, just a year later in the midst of the pandemic, 100% expected virtual trials to be a major component of their portfolios, and 89% expected to run a trial with most activities conducted in participants’ homes. The times are changing. 

In the foreseeable future we will see DCT continue to iterate and find the best methods for executing effective and efficient research. During this time of evolution technology will be leveraged to advance DCT solutions around issues like recruitment, trial diversity, data integrity, and security. But most importantly we will see research trials becoming part of a healthcare practitioner’s daily arsenal for treating their patients. In other words, research will center around the patient and their healthcare team, not the other way around.

Making Participants’ Doctors Part of the Trial Team

Among the industry’s most recent and significant DCT innovations is Bring Your Own Physician (BYOP). The idea is simple, focus on working with the patient’s chosen physician administering the majority of standard medical care and data collection, while verifying and submitting the details through technology to the PI’s team—thereby improving recruitment, compliance, and completion rates for patients. This approach is exceedingly important to the industry because not all trials can be done from home, many require specific and complex treatment plans, and people are reluctant to travel to participate in a research study.  

The BYOP model is key to unlocking the greatest potential for a decentralized trial. First travel concerns are eliminated by the program design and the local convenience is more attractive to the patient. Second the patient continues to work with their trusted care team, which improves engagement and compliance with the trial, regardless of complexity. And finally, recruitment is dramatically improved with the ability for physicians across the nation making the trial available to their patients.

Let’s consider a real-world example.

A recent trial required data from pregnant women. Mid-pregnancy is a time when you are very unlikely to pry an expecting mom away from her clinician and into a research environment. However, leveraging the BYOP model, the patient’s own trusted care team can conduct regular exams, collect real-world data and talk about trial-related concerns and experiences, while contributing this information to the trial database.  

Working with their own OB/GYN has also proven to help with retention and consistent compliance. Quite simply these moms-to-be are already attending many medical appointments, so additional touchpoints are not necessary, making the experience easier on the patient. Also, these trusted patient – physician relationships tout more open lines of communication, enabling trial sponsors to boost the quality and accuracy of information gathered throughout the process. 

To make matters even easier, technology integrations mean that these OB/GYNs are not required to do any additional work, in most cases. The data are recorded as part of the patient’s normal care, then technology securely provides the necessary information to the researchers.

The Future Is Patient-Focused

Thanks to modern technology, patients and physicians can bring forward the idea of a clinical trial as a care consideration under the BYOP model. Potentially, clinical research could quickly be considered a standard interventional treatment offered as a care option to eligible patients, making local primary care physicians, specialists, and clinic teams key members of many clinical trial teams. And let’s be honest, solving for the many challenges associated with recruitment and compliance will dramatically advance research as a whole.

The future of medical research is patient focused. Increasingly, eligible patients will participate in clinical trials locally with their own doctors via BYOP and trial participation will become a standard of care option.  As access and diversity expand, each study’s scale, depth, and quality will continue to improve. Although there are undoubtedly some state and federal regulatory hurdles ahead, DCTs have already demonstrated their efficacy and earned the support of regulators and other industry stakeholders. The future of clinical trials is here, and it is a future of decentralization, virtual technology, greater patient access and wider participant diversity.

Tom Lemberg is the founder and CEO of San Francisco based Curebase. Their solution is a decentralized clinical trial software platform and clinical service provider. Curebase enables any patient, anywhere, to participate in clinical trials at home and with their own doctor. He can be reached at tom@curebase.com.