Oversight and Implementation of Decentralized Elements in Clinical Trials

Oversight and Implementation of Decentralized Elements in Clinical Trials

Subprojects:

IRB/EC Considerations for DCT Review

Proportionate Oversight in Decentralized Clinical Trials (DCTs)

The MRCT Center and Medable co-led two collaborative initiatives focused on the oversight and implementation of decentralized elements in clinical trials. Drawing on the expertise and input of dedicated multi-stakeholder task forces convened for each initiative, the projects developed practical resources to support the planning, review, conduct, and monitoring of clinical trials that incorporate decentralized elements.

While almost every trial utilizes some elements of technology, clinical trials with decentralized elements are highly variable in how decentralization is implemented, from remote recruitment utilizing social media, electronic consent, and remote visits through either virtual visits or local providers, to the use of devices and software for data collection, among other approaches. There is also significant variability in IRB/EC understanding of these approaches and therefore often delays in review and approval.

Through these projects, the following resources were developed to support the ethical review and oversight of clinical trials with decentralized elements:

Ethical Review of Decentralized Clinical Trials (2023)
Provides guidance for Institutional Review Boards (IRBs) and Ethics Committees (ECs) on the unique ethical and operational considerations associated with decentralized and hybrid clinical trial designs.
Proportionate Oversight in Decentralized Clinical Trials (2026)
Provides a framework and practical tools to help sponsors, investigators, and sites determine and implement oversight approaches that are proportionate to the decentralized elements used in a trial.

Together, these resources support both the ethical review and risk-proportionate oversight of clinical trials with decentralized elements, helping to facilitate efficient review processes and appropriate implementation throughout the clinical trial lifecycle.

OBJECTIVES

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

KeY MILESTONES

February 2024: Launch of “PI Oversight in DCTs” taskforce
June 2023: Release of the IRB/EC Considerations for DCT Review
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