In July 2021, the Industry Standard Research (ISR) Report on Hybrid/Virtual/Decentralized Clinical Trials Market Outlook surveyed 109 industry leaders worldwide who had been involved in DCTs over the past year.{1} Respondents anticipated a 12% increase in hybrid trials over the next two years—and predicted that DCTs would outstrip traditional trial models within three years. They praised the increased ease of patient recruitment and improved patient compliance that DCTs generate. They were also impressed with the access to rich data—often sampled multiple times a day—representing a trove not possible with traditional trials.
Yet that does not mean all is perfect. DCTs—including for our purposes the range of hybrid onsite/offsite, siteless, remote, and virtual trials, depending on your favorite terminology—rely heavily on technology for data capture, and immature technology can pose problems. Therefore it is critical that sponsors choose a contract research organization (CRO) with the specialized experience to foresee and forestall this new breed of potential issues.
From a CRO’s standpoint, decentralization is not revolutionary. Technologies used for electronic patient-reported outcome (ePRO) collection and electronic informed consent (eConsent), just to name a few, are longstanding facets of trial management, and other technologies have steadily gained broad-based acceptance and popularity. Further, as wearable technologies and home monitoring devices become standard accessories for the health-conscious, their data gathering in clinical trials seems increasingly natural.
These devices are also producing better results. The rising popularity of DCTs is based primarily on their ability to better support patients—saving them time and out-of-pocket costs while minimizing their exposure to outside pathogens. That increased support has led to improved compliance and better data, which are, after all, the holy grail of any trial. Yet the sheer volume of data produced is one of the key challenges created by the surge in wearables. Data arrive day by day—sometimes minute by minute—often from multiple devices. Accurately collecting, managing, and analyzing all these data can be overwhelming. Yet, those processes are also critical to trial success—adding pressure to the task of choosing a CRO wisely.