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.
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Providing systematic guidance for protocol writers to address ethical considerations in planned clinical trials and for ethics committee members to ensure study protocols have adequately addressed ethical issues
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
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).
The MRCT Center held a 3-day training workshop on International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6(R2) at Harvard Faculty Club last month.
The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.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.
The MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public. It will be held from 8:00 AM – 1:00 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.”