Pilot Training on International Conference on Harmonisation Good Clinical Practice (ICH GCP): The MRCT Center is hosting a 3-day training for international regulators and professionals on ICH GCP.
Clinical trials are closed prematurely for a variety of reasons, including for scientifically-driven reasons of efficacy, safety, and futility wherein there is no justification for continuing to enroll participants. The majority of clinical trials, however, terminate early as a result of operational issues—such as inadequate recruitment, commercial product viability, insufficient funding or resources, or de-prioritization by an investigator, institution, or sponsor. The decision to terminate a trial raises complex ethical questions regarding the appropriate communication with and responsibilities owed to participants.
Released on: February 27, 2020
Developed by: MRCT Center Bioethics Collaborative
See Meeting Summary
Efficacy and safety of medicines can vary depending on a number of intrinsic and extrinsic factors, such as an individual’s genetic background, ethnicity, lifestyle, and age. In appreciation of these differences and in the interest of generating generalizable knowledge—the participant population enrolled in a clinical trial ought to be representative of the general population. Despite this normative ideal, underrepresentation of gender, sex, ethnic, and racial minorities in clinical trials persists.
Presently, there is no operational framework to guides investigators in designing, and IRBs in evaluating, recruitment methodologies and payment proposals to international research participants. This lack of guidance has been a cause for concern amongst regulators, trialists, advocacy groups, and research participants –especially when conducting clinical trials in low-and middle-income countries (LMICs).
July 2021: Fair payment and just benefits to enhance diversity in clinical research
November 2020: On Measuring Attitudes About Payment for Research
February 2020: Economic Vulnerability and Payment for Research Participation
October 2019: Ethics of Payment in Clinical Research
August 2019: Relocation of Study Participants for Rare and Ultra-Rare Disease Trials: Ethics and Operations
April 2018: Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials
February 2018: A Framework for Ethical Payment to Research Participants
MRCT Center 2017 Annual Meeting Agenda
MRCT Center 2017 Annual Meeting Proceedings
MRCT Center 2017 Annual Meeting Slides
MRCT Center 2017 Annual Meeting Keynote Slides
Key themes of the meeting included MRCT Center projects:
The MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public.
1:00 PM- 4:30 PM, the MRCT Center Executive and Steering Committee met in closed session.
