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.
Oversight and Implementation of Decentralized Elements in 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.
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
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
Emina Berbic, MPH, Program Manager, MRCT Center
Pam Tenaerts, MD., Chief Scientific Officer, Medable, Inc.
Andre Chiriac, MD., Vice President of Medical, Medable, Inc.
The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs) and presented the work at a recent webinar, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”
Dr. Barbara Bierer, MRCT Center Faculty Director, will be speaking on “Improving the Performance of Clinical Trial for Global Directives” at the Global Clinical Research Summit in Seoul on September 7th. Learn more
Description: We are delighted to announce a collaboration with Clinical Data Interchange Standards Consortium (CDISC) on the MRCT Center Clinical Research Glossary. This marks an important first step in making plain language a global clinical research standard. The MRCT Center Clinical Research Glossary was piloted in 2020 to test the process of creating a plain language glossary of commonly used clinical research terms that is freely available to everyone.
Please join us on April 5 from 11 AM – 12 PM ET for a joint webinar with the MRCT Center and CDISC. Learn about MRCT Center’s robust process of developing the plain language glossary, the CDISC public review, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
