Source: Validic: How Digital Health Devices and Data Impact Clinical Trials
Amidst a backdrop of the hotly debated topic of drug prices, a new report shows just how keen biopharma companies are to use digital health tools to reduce drug development costs. The expense of clinical trials tends to soar in the later stages, reflecting the growth in the number of participants and the cost of recruiting them.
The report by Validic/BioPharma Dive surveyed 166 participants across biopharma, contract research organizations and health IT. Despite the fact that 97 percent of respondents said they would use digital health technologies in clinical studies in the next five years, the report tempers that excitement with the sober reality that significant challenges lay ahead.
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More than 60 percent of participants said they had used digital health tools in clinical trials, mostly through mobile apps (47 percent) and in-home, clinical-grade medical devices such as blood pressure and glucose monitors (45 percent). The attraction of digital health for clinical trials stems from its potential to deliver real-time data, automate data collation and remotely monitor study participants, theoretically at home.
Remote data collection would lead to fewer site visits, lowering travel costs for principal investigators, the report noted. Digital health tools also have the potential to make clinical trials a more passive experience for participants, particularly through wearables and sensors. Indeed, these two areas are viewed as the future of digital health tech in drug development. About 67 percent surveyed said they want to use wearable activity trackers in future clinical trials and 64 percent reported they would like to use sensors, such as ones placed in pill bottles to measure medication adherence.
Data accuracy and lack of standardization continue to be the dominant concerns threatening the progress of studies underpinned by digital health tech and yet, they’re just the beginning. Additional challenges to puzzle out include how to analyze data in a meaningful way, figuring out the best device to use, and how to integrate data from devices into a clinical trial platform, according to the report. How willing will patients be, let alone physicians, to use digital health devices? Will the U.S. Food and Drug Administration reject trial results that include digital health data?
In most cases biopharma companies are in the early stages of making digital health data gathering part of clinical trials as they wrestle with these issues. Still, a spokesperson for Durham, North Carolina-based Validic said the company is beginning to see digital technology incorporated into trials to develop a streamlined trial process and improve the speed to market for a drug.
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