Decentralized Clinical Trials: A Pandemic Silver Lining

Adapting to change is a necessity to navigating the world in which we live. It can be hard for many of us, particularly since it is human nature to focus on the negative aspects of change, specifically, what was rather than the good of what could be.

Yes, I will admit I am one of those people: a self-identified optimist…even when thinking about the pandemic over the last 18 months. However, it seems that many Americans agree that the pandemic yielded moments of surprise. In fact, a study conducted by the Pew Research Center revealed that 73 percent of Americans surveyed have experienced at least one unexpected silver lining due to the pandemic.

For me, one silver lining was the accelerated development of decentralized clinical trials (DCTs) and the potential impact for patients. Prior to COVID-19, the biopharma industry had made some progress in leveraging technology to change how clinical trials were conducted. Still, the pace of change was slow…maybe too slow for some of us.?For far too long, people who qualify for and participate in a clinical trial have been inconvenienced by various study requirements, such as the need to travel from their homes to academic institutions or other facilities for monitoring. This can be both time-consuming, inconvenient, and expensive.

Then, in March 2020, the pandemic struck, and almost overnight the way we conduct clinical trials evolved. COVID-19 reinforced the need for modernized clinical trial approaches and emphasized the importance of flexible digital solutions.?Companies that sponsor clinical trials are more capable and equipped to bring trials to patients rather than bring patients to trials. Instead of relying on in-person data collection methods, DCTs helped capture data from patients’ own homes with the help of sensors, wearable devices, cameras, and other technologies.

The move to DCTs has an array of potential benefits ranging from quicker access to data for sponsors and researchers to providing an opportunity for broader, more diverse participants.

Time Matters

DCTs leverage Real World Evidence (RWE) which alters the way we analyze clinical trial results, enabling trial investigators to access and analyze data in real-time.

The potential impact on patients cannot be overstated. Time is the most precious resource to patients. Time making memories with their families, quality time with friends, time to work toward career goals that may not seem attainable post-diagnosis. Clinical trial decentralization and technological integration could enable companies to bring life-changing therapies to patients– therapies that could give patients more time— faster than ever before.

Increase in Trial Diversity

Underrepresentation in clinical trials is a widely recognized problem within our industry. In the United States, people of color represent about 39% of the population but only 2-16% of clinical trial participants.

There are a range of factors at play that contribute to this disparity, but most are rooted in access. Clinical trial participation requires access to an understanding of the intricacies of the healthcare system. Access to the financial resources required to make the sacrifices that often come with study enrollment. In a perfect world, each patient, regardless of race, ethnicity, location, socioeconomic status or gender, would have the same level of access. It would be a level playing field. But that’s simply not the case. That’s not acceptable.

In our industry, we have seen monumental positive change that will transform the way we innovate. DCTs enable faster scientific discovery and help the pharmaceutical industry chip away at access barriers that have led to health inequities by making it possible for traditionally underrepresented populations to participate in important research. A silver lining indeed.