In recent years, increasing attention has been paid to a method of clinical trial design that de-emphasized clinical site visits in lieu of relying on patients for generated and collecting more data themselves. Among the drivers for this change were to simplify trial design, allow patients to avoid some portion of site visits, involve patients to a greater degree in the clinical trial process, and ultimately positively impact adherence and retention. A coincident driver has been the growth of remote monitoring capabilities, which have been a focus of the Risk-based approach to trials in design, execution, and monitoring. The transition in this direction was enhanced by the growth of smart devices and wearable monitors, which provide a relatively reliable data collection channel and provide a level of patient oversight.

The COVID pandemic has reshuffled the deck and made remote, digital, de-centralized clinical trials not so much an effort to improve certain key metrics as it is has made them essential to continuing to operate trials while maintaining and adhering to the various restrictions meant to limit the spread of the virus.

On the assumption that reducing the reliance of a trial on patients residing within a certain radius around a clinical site is a good thing, the impact of COVID in driving adoption of decentralized trials can be view as a positive outcome. In the eight months since the start of the pandemic in the USA, signficant resources have been working to realign the approach toward decentralized trials at a number of large organizations and new companies that are focused on enabling and supporting these trials for sponsors have grown substantially.