Comparison of Participant and Site Perceptions of Decentralized Clinical Trials in the USA.

OBJECTIVE

To define potential participant and site perceptions of decentralized clinical trials (DCTs).

PARTICIPANTS AND METHODS

Two qualitative surveys were conducted between January 2022 and August 2022 to assess current awareness of, and perceptions about, DCTs. The first survey received 141 responses from staff at our clinical trial sites; the second survey received 481 responses from US-based healthy individuals or those living with an illness.

RESULTS

There was a difference in perceptions and willingness between participants and sites toward DCTs. Participants expressed more comfort with hybrid and fully remote trials than did the sites. Site staff were more concerned and less trusting than participants of DCTs; participants' main concerns were regarding practicality and medical safety, whereas the focus for sites was on burden, trust, and security. Both sites and participants expressed confidence in fully remote clinical study activities when they have appropriate support; sites were less tolerant of fully remote clinical study activities if professional support was not provided. Overall, sites were more willing to manage the use of DCT-related technologies than were participants. It is highly likely that participants' willingness to manage DCT technologies relates to the perceived burden of use (ie, willingness decreases as burden or impact on daily life increases). Sponsors, contract research organizations, and DCT vendors generally had positive views on DCTs. However, different stakeholders had different concerns.

CONCLUSION

These results highlight the need for collaborative research and development of DCTs, as well as a clear DCT framework and regulatory guidance.