Oversight and Implementation of Decentralized Clinical Trials
The MRCT Center is collaborating with Medable and other organizations to address the oversight and conduct of decentralized and hybrid clinical trials (collectively, DCTs), with a focus on planning and monitoring the trial appropriately.
While almost every trial utilizes some elements of technology, DCTs are highly variable in terms of the elements of ‘decentralization’ deployed throughout the trial, from remote recruitment utilizing social media, electronic consent, remote visits through either virtual visits or local providers, and use of devices and software for data collection, among others. There is also significant variability in IRB understanding of DCTs and, therefore, often prolonged delay in approval.
Working with a multi-stakeholder task force, the first initiative of this project addresses the ethical review of DCTs, focusing on how DCTs differ from traditional clinical trials. Next, specific recommendations for the roles and responsibilities of PIs (including PI oversight) and sponsors will be addressed.
- Provide guidance and tools for IRBs, sponsors, investigators and their study teams regarding ethical review and approval of DCTs
- Consider the specific responsibilities of principal investigators, sub-investigators, study staff, sponsors, and vendors in DCTs
- Develop resources for use by stakeholders involved in DCTs
- June 2023: Launch webinar “Ethical review of Decentralized Clinical Trials: Tools, resources and best practices”
- May 2023: Meeting held in Washington DC with Key stakeholders to discuss PI Oversight in DCTs
- March 2023: A multi-stakeholder workgroup of ~30 people has completed a series of meetings, and the core team developed deliverables for ethical review of DCT trials
- June 2022: Conclusion of task force meetings; key deliverable development begins
- October 2021: Launch of DCT taskforce
project Leadership & sTAFF
- Barbara Bierer, MD., Faculty Director, MRCT Center
- Hayat Ahmed, MSc., Program Manager
- Pam Tenaerts, MD., Chief Scientific Officer, Medable, Inc.
- Leanne Madre, JD, MHA, Vice President of Evidence & Best Practices, Medable, Inc.
- Andre Chiriac, MD., Vice President of Medical, Medable, Inc.