Countway Library at Harvard Medical School, Boston, MA
Topic: Ethical Challenges of Phase 1 Clinical Trials.
Dr. Barbara E. Bierer, MRCT Center Faculty Director, will be a commentator at the Harvard Medical School Center for Bioethics’ September Research Ethics Consortium.
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2018 Annual Meeting were:
European Union General Data Protection Regulation (GDPR)
Representation of Diverse Populations
Advancing the Study of Clinical Trials
Capacity Building
Health Literacy in Clinical Research.
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
Dr. Barbara Bierer, MRCT Faculty Director, will co-present at the 2019 DIA Global Annual Meeting: “Conversations with the Participant: Layperson Summaries and Return of Results”
The MRCT Center’s project on Representation of Diverse Populations in Clinical Trials and Research aims to provide a principled, stakeholder approach to optimize the inclusion of diverse populations in clinical research when appropriate.
The focus of the work has been to understand, clarify, and promote the scientific basis for and ethical responsibilities to include participants of diverse populations in clinical trials.
The MRCT Center is excited to host the first face-to-face meeting for members of the workgroup. This event will provide an opportunity for the members to meet in-person to review, revise and discuss the draft guidance document. They will deliberate on points of disagreement, determine gaps that may be missing, and finalize deliverables.
Breakfast and lunch will be provided. Please note that invitees will need to register for the event in advance.
We invite you to join the launch of our Health Literacy in Clinical Research website, through a webinar, on Monday, October 21, 2019, 12:00-1:00 PM EDT.
About the project: Taking a systems-based approach, our MRCT Center workgroup has developed clinical research focused health literacy tools and resources for all clinical research stakeholders including sponsors/funders, investigators and study teams, and institutional review boards/ethics boards to use throughout the clinical trial life cycle. Read more
The MRCT Center Annual Meeting was held in the morning of December 4, 2019 (8:00 AM -1:00 PM). The keynote speaker was Professor Chenguang Wang, Tsinghua University Law School.
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2019 Annual Meeting were:
Life sciences Regulation and Policy in Today’s China
Health Literacy in Clinical Research
Real World Evidence – OPERAND
Representation and Inclusion of Diverse Populations in Clinical Research
EU General Data Protection Regulation (GDPR)
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
The MRCT Center Annual Meeting will be held virtually this year. We will review and discuss ongoing MRCT Center projects and emerging issues. This meeting is open to the public. If interested, please register here.
Agenda to include:
Keynote speaker: Michelle McMurry-Heath, MD, PhD, President and CEO of Biotechnology Innovation Organization (BIO)
Promoting Global Clinical Research in Children: Perspectives on patient/family/carer engagement
Diversity, Inclusion, and Equity in Clinical Trials: Update on MRCT Center Guidance, current and forthcoming activities, and collaborations. The panel will include a discussion of recent PhRMA principles on clinical trials diversity by Dr. Richard Moscicki, a presentation of social determinants of health by Dr. Monica Webb Hooper, NIH, and comments by Dr. Roberto Lewis, Columbia University.
European Union General Data Protection Regulation (GDPR): recent updates
For agenda, speaker biographies, proceedings and slides, please see Annual Meeting page.
Topic: The FDA Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck).
Drs. Bierer and Clark will introduce the recently released MRCT Center’s Diversity Framework, titled Achieving Diversity, Inclusion, and Equity In Clinical Research. After providing a brief introduction, background, and contextual orientation to listeners, Drs. Bierer and Clark will highlight the ways in which stakeholders can contribute to increasing diverse representation in clinical research and, ultimately, improving health equity and public health domestically and abroad.
Topic: “Achieving Diversity, Inclusion, & Equity in Clinical Research” webinar moderated by MRCT Faculty Co-Director Mark Barnes and Ropes & Gray Partner with speakers Dr. Barbara Bierer, MRCT Faculty Director, Dr. Eldrin Lewis, Professor of Medicine at Stanford University and Dr. Paul Underwood, Medical Director at Boston Scientific.