Clinical Trial Diversity and Accessibility: Managing the Data Demands
As the pharmaceutical industry seeks to improve health outcomes globally, a critical area of investment is increasing participant diversity. We know that gender, age, and race have profound effects on the way pharmaceuticals are metabolized. That is why the FDA has been encouraging diversity in clinical trials for years, although without mandate nor incentive. The burden has largely fallen on industry groups to work out the how. As such, the levels of diversity have slowly and slightly improved, but seem to have plateaued in 2019. While 2020 has impacted so many industries negatively, it may prompt a positive shakeup in the way we conduct, and who we enroll in, clinical trials.
Clinical Trial Diversity and Accessibility: Managing the Data Demands
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Virtual clinical trials, sometimes referred to as decentralized trials or hybrid studies, allow some to all of the study to be performed outside the clinical setting, in people’s homes or at local medical facilities. The idea is not new, animal health studies have been following this model for ages, going to the ranch or farm to collect data; it’s easier than bringing a herd to the vet’s office. But for human health, the industry has been apprehensive to leave the stability and control of the clinical visit.
There are many benefits of decentralized trials. Larger patient pools mean better diversity. Reducing the burden of travel and weekday visits opens up clinical trials to middle- and low-income as well as rural participants. It also lowers dropout rates because of schedule conflicts. But even in our digital age, there are very real issues. The fragmentation of data collection technologies poses a problem. For example, your heart monitor, digital scale, and ePRO all send data to different systems with different security, data privacy, GxP compliance, and data-retention policies.
“From a data management standpoint, companies typically have a myriad of different systems that are used to collect, store, and analyze data, and that fragmentation creates potential risk at every endpoint.” - Alok Tayi, Ph.D., Vice President of Life Sciences
We don’t have a crystal ball and we can’t be sure what “new normal” activities will actually stick around post-pandemic. But virtual clinical trials are a real alternative to traditional study designs an alternative that could have a real impact on trial diversity and improved treatments. But it is no quick fix. If we as an industry and the regulatory bodies want to make a real impact on clinical trial diversity, we will need to spend some time ironing out the security, privacy, compliance, and technical issues that are holding virtual trials back.
For more information on virtual clinical trials, download the BioPharmaDive report on diversity and accessibility.
