IACRN supports decentralized clinical trials in ensuring equitable access and participation in cutting-edge research, and submitted recommendations for the DCT guidance to the FDA.
The FDA released a draft guidance for Decentralized Clinical Trials (DCT), seeking public comments. An IACRN working group, consisting of the Research Committee and IACRN President Laura Baker, was established to review and respond.
Many IACRN members have experience with DCT trial design or models due to COVID-19, where virtual study visits had to be implemented to accommodate clinical studies. Our aim as an association was to demonstrate our members' expertise and experience in clinical research.
The importance of DCT in reaching underserved communities such as rural areas and home-bound individuals is highly significant. DCT facilitates inclusion by providing opportunities to access advanced medical research which would otherwise be inaccessible to some groups. It also removes geographical obstacles by enabling individuals to participate in clinical trials from remote areas or digitally, eliminating the need for travel to a study site. DCT can also help reduce health disparities by making it easier for underrepresented groups to participate in clinical research.
Nevertheless, as nurses, the IACRN membership note the challenges (and opportunities) in DCTs operations with unique perspectives to advocate for the participants, the workforce, and the science. The IACRN recommendations on this FDA draft guidance have been submitted to FDA and are now posted publicly at Regulations.gov.
Read IACRN's Submission/DCT Recommendations to the FDA