Improving regulatory capacity to provide a unified standard for conducting clinical trials.
Identifying, recruiting and training leaders from emerging regions who have expertise in medicine or statistics and experience in clinical trials, to equip them to serve on Data Monitoring Committees (DMCs).
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Developing an ethical framework and toolkit for addressing post-trial responsibilities related to access to investigational product, access to medical care, and access to infrastructure.
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture and to returning individual results.
The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.
The Joint Task Force (JTF) for Clinical Trial Competency has updated and released its Core Competency Framework Version 2.0 for use by clinical research professionals and staff worldwide.
Aug 28, 2017
Post-Trial Responsibilities Framework Released
We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) .
The MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public. It will be held from 8:00 AM – 12:45 PM at the Harvard Faculty Club. For registration, please click here.
Dr. Barbara Bierer, MRCT Center Faculty Co-Director, will be presenting at the KoNECT International Conference on “Emerging Ethical Issues in Clinical Trials.”
Dr. Barbara Bierer, MRCT Center Faculty Co-Director, will be presenting at the 6th International Oda Memorial Symposium on “Multi-Regional Clinical Trials in the USA: ethical, operational, and regulatory challenges.”