The Association of Clinical Research Professionals
Decentralized Clinical Trials: Perspectives for Clinical Research Professionals
This new white paper, published in March 2022, assesses the significant implications of how decentralized clinical trials (DCTs) leverage digital technologies to interact remotely with trial participants.
Vastly increased DCT usage in the past two years has enabled clinical research to advance during the COVID-19 pandemic as part of a trend that is forecast to continue.
Authored by members of ACRP’s Fellows Advisory Panel, the paper notes that potential benefits of DCT’s include a reduced need for sponsor and study site resources, and a better, more convenient study subject experience with fewer, shorter clinic visits and less frequent face-to-face contact.
Concerns related to DCT elements include the potential for missed opportunities to detect safety signals, increased data errors, and greater reliance on study subject compliance.
Key recommendations of the paper include:
- Sponsors, contract research organizations, vendors, and sites should review and potentially customize each study plan to account for decentralized elements.
- Clinical investigators should consider adapting site infrastructures to conduct studies that will likely require fewer patient site visits and increased remote data collection locations.
- Sponsors and CROs should consider modifying standard operating procedures and study-specific plans to train study subjects, provide access to study coordinators or coaches, and enable electronic communications.
- Clinical teams may need to expand to support digital communication and data collection, including electrical engineers, computer scientists, data engineers, or informatics specialists.
- Financial aspects of clinical research may need to be modified to reflect new activities, responsibilities, and data collection locations.
- Training curricula offered by ACRP (and other educational organizations) for clinical research professionals need to adapt to a wider range of new clinical operation models and roles.
