How physicians and patients are partnering to evolve the decentralized clinical trial model

The COVID-19 pandemic proved that the healthcare industry’s traditional model for clinical trials represents a limited model for medical research. What we define as conventional trials are costly, slow, and cap diversity and participation, and as a result often stifle the research that they are intended to promote. However, decentralized clinical trials (DCTs), which leverage technology to collect patient data remotely, are now changing the industry by helping to increase trial access and participant diversity.

As DCTs continue to evolve, we see that technology is allowing 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 care. This is 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 adjust their clinical trials to better navigate the challenges presented by the pandemic. Some trials that began centralized became DCTs, making the process more patient-centric. The industry quickly saw that the recruitment, diversity, and speed benefits of the DCT approach were compelling. The FDA continues to support this guidance today. 

The volume of DCTs is expected to grow 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 significant component of their portfolios, and 48% expected to run a trial with most activities conducted in participants’ homes. However, 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 industry is changing. 

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

Leveraging participants’ doctors as part of the trial team

One of the industry’s most recent and significant DCT innovations is BYOP. The idea is simple, focus on working with the patient’s preferred physician administering the majority of standard medical care and data collection, while validating and submitting the details through technology to the PI’s team, thereby improving recruitment, compliance, and completion rates. This approach is exceedingly valuable to the industry because not all trials can be done from home, many require detailed and intricate treatment plans, and people are reluctant to travel to participate.

The BYOP model is crucial to unlocking the greatest capabilities for a decentralized trial. First, travel issues are eliminated by the program design and the local accessibility is more attractive to the patient. Second the patient continues to use with their trusted care team, which improves engagement and compliance with the trial, regardless of complexity. And finally, recruitment is markedly improved with the ability for medical doctors across the nation to make the trial available to their patients.

Let’s consider a real-world example.

Mid-pregnancy is a time when you are very unlikely to pry an expectant 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 issues and experiences, while adding this information to the trial database.

Having trial participants work with their own OB/GYN can also improve trial retention and consistent compliance. Simply, moms-to-be are already attending many health appointments, so additional touchpoints are rarely necessary, making the experience easier on the patient. Also, these trusted patient-physician relationships establish more open lines of communication, enabling trial sponsors to boost the quality and accuracy of information gathered throughout the process.

Further, technology integrations mean that OB/GYNs are not required to do any additional work, in most cases. The data is 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, both patients and physicians can suggest the idea of a clinical trial as a care option under the BYOP model. Clinical research could then potentially be considered a standard interventional treatment offered as a care alternative to eligible patients, making local primary care physicians, specialists, and clinic teams key members of many clinical trial teams. Furthermore, 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, qualified 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 undeniably 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.

_{About the Author}

_{Tom Lemberg is the founder and CEO of Curebase.}