Best Practices

What is this Initiative?

This initiative collects current DCT regulations and identifies relevant gaps within regulatory guidance to influence DTRA’s regulatory policy strategy. This project conducted and provided a gap analysis of current regulations related to decentralized clinical trials (DCT) and provided proposals to drive awareness and inform regulatory agencies of the gaps in such regulations. The goal of the initiative is to leverage this analysis to engage with regulators, respond to newly released guidance/regulations, and ultimately propose collaborative solutions to address regulatory uncertainties.

New initiatives or other working groups may be chartered based on findings from this initiative. As a conclusion to this work, this workstream has been absorbed into DTRAs Regulatory Forum, which meets monthly and drives forward different work in the Regulatory space for DCTs.

1. Gap Analysis Spreadsheet as of July 2022

Team completed a Gap analysis of where current regulations are not addressing DCT conduct with outreach/engagement with Regulatory Authorities as appropriate

Download the Gap Analysis Spreadsheet >

2. FDA Draft Guidance Response

DTRA Membership collaborated and compiled a robust response to the FDA on the Draft Guidance for DCTs.

Download the DTRA Draft Guidance Response >

3. DTRA Response to NIH Request for Information

DTRA Membership shared comments on how DCTs may be designed to be more effective, efficient, and equitable to bring more interventions to all people, faster.

Download the DTRA NIH RFI Response >