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.
Sarah White, MRCT Center Executive Director, will co-present (1) ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure Requirements and (2) Ideas and Practices for for Compliance and Auditing of Single IRB Studies at the Advancing Ethical Research Conference.
Ropes & Gray and the MRCT Center will be co-hosting a breakfast roundtable discussion regarding the impact of GDPR on clinical research with Paul Mills from the United Kingdom’s National Health Service Health Research Authority on Monday, January 7, 2019 from 9:30 a.m.-11:00 a.m. at the Ropes & Gray office in San Francisco.
Dr. Mills, who is an official within the United Kingdom’s primary human research and clinical trials regulatory agency, has been working for the past nine months in advising commercial and non-commercial sponsors of research on approaches to take in implementing GDPR in research across the United Kingdom. As part of this process, he has reviewed the transparency language of approximately 170 research sponsors from around the globe and has helped to implement processes to minimize any disruption imposed by GDPR on the conduct of health research in the United Kingdom.
Dr. Mills has agreed to address questions from attendees during the roundtable. Please send questions in advance to David Peloquin (david.peloquin@ropesgray.com) and Leslie Thornton (leslie.thornton@ropesgray.com), the two Ropes & Gray attorneys who will be moderating the roundtable. We expect a frank and engaging discussion.
Dr. Barbara Bierer, MRCT Center Faculty Director, will co-present in two sessions at the 2019 AAHRPP Annual Conference: May 22, 2019, 10:30-11:45 AM: GDPR: Considerations for Implementation May 23, 2019, 2:15-3:30 PM: Is There a Right Not to Know Your Genetic Data? Panel Discussion
800 Boylston Street Boston,
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As the official launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today.Dr. Robert Califf, former Commissioner of FDA, delivered the opening keynote entitled, ‘New Possibilities for Medical Product Safety in the Digital Revolution.’ The conversation that followed was expansive, thought-provoking, and dynamic. Diverse perspectives on many topics were considered, including the sources, curation, and use of data; the importance of understanding the benefit to risk and not simply a safety risk; communication of the balance of benefit and risk to patients; and communication between stakeholders, regulators, and the global population. The MRCT Center will continue to explore the themes identified during the meeting to develop a concrete plan for the future.
Vivli, the Multi-Regional Clinical Trials Center (MRCT Center) and Association of American Medical Colleges (AAMC) present a discussion on methodologies for appropriating credit in data sharing.
Dr. Barbara Bierer, MRCT Center Faculty Director, is one of the presenters. The webinar will be held Tuesday, November 12th at 11 AM EST.
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.
