Focus Area: Ethics, Conduct, and Oversight
The MRCT Center Bioethics Collaborative is a neutral forum to foster the discussion of bioethical issues among stakeholders involved in global clinical trials for drug and device development. Meetings bring together individuals from academia, industry, patient groups, ethics committees, and government to share, define, study, and propose ethical frameworks to address issues arising in the context of the design, conduct, and oversight of multi-national clinical trials. The MRCT Center runs the Bioethics Collaborative as a cooperative endeavor that meets three times per year.
A planning committee chooses discussion topics in advance. The MRCT Center then prepares a case statement of the topic to be discussed and circulates the case statement, relevant examples and readings prior to the meetings. The meetings themselves follow modified “Chatham House Rules,” by commentary will not be attributed to any individual, not to their institutional affiliation. After the meetings, the MRCT Center generates a summary of the issues and discussion for participants. At each meeting, the attendees decide whether and how the summary will be adapted for broader distribution or publication.
The MRCT Center is grateful to the following sponsors of the MRCT Bioethics Collaborative:
- Genentech, Inc.
- Johnson & Johnson
- Merck & Co., Inc.
- Pfizer Inc.
- Takeda Pharmaceuticals International, Inc.
Current status: Active
Impact: Discussion forum for pressing ethical issues in multi-regional clinical trials
- Encourage careful discussion and collective understanding of bioethical issues related to global clinical trials
- Develop approaches to address emerging bioethical issues
- October 2016: Inaugural meeting: Expanded access to investigational products
- January 2017: Early termination of clinical trials
- May 2017: Ethnic and gender diversity in clinical research
- October 2017: Fair payment to and recruitment of international research participants
- December 2017: Released Expanded Access: A Practical Approach for Sponsors, Physicians and Institutional Review Boards
- January 2018: Enabling informed selection of clinical trials: institution, provider, and participant responsibilities: Summary notes available
- April 2018: The Return of Individual Results to Research Participants and Axes of Communication: Summary notes available
Project Coordinator: Emily Statham