June 1, 2023 @ 1:00 pm – 3:30 pm
Challenges in Decentralized Clinical Trials – Open Discussion Forum
Challenges in Decentralized Clinical Trials – Open Discussion Forum
The provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization
Proceedings from: Joint Task Force for Clinical Trial Competency Biannual Global Meeting on May 2, 2023
Held at: Virtual Meeting
Developed on: June 2023
Developed by: MRCT Center Pediatrics Workgroup and translated by the King Hussein Cancer Center
Developed on: June 2023
Developed by: MRCT Center Pediatrics Workgroup and translated by the King Hussein Cancer Center
Developed on: June 2023
Developed by: MRCT Center Pediatrics Workgroup and translated by the King Hussein Cancer Center
Developed on: June 2023
Developed by: MRCT Center Pediatrics Workgroup, translated by the King Hussein Cancer Center
Published on: May 25, 2023
Published in: National Center for Biotechnology Information, NIH
Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.
DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.

Description: Since the updated Individual Return of Results toolkit was released last year, the MRCT Center has continued collaborating with leaders from academia, patient advocacy groups, and industry to create a series of case studies. These cases detail the experiences of five organizations planning and implementing procedures to return individual research results and data to participants, highlighting ethical, scientific, operational, regulatory, and technical considerations that should be considered. In this webinar, case study authors shared their experiences, successes, and challenges in a moderated conversation.
Click here for the webinar resources.