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
For more information, click here.
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”
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.
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 This event will provide an opportunity for the members to meet in-person to review, revise and discuss the draft guidance document.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.
Please register here
For more information, please see our flyer.
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
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.
Read more – https://vivli.org/uncategorized/credit-for-data-sharing-webinar/
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.
The principal topics discussed at the MRCT Center 2019 Annual Meeting were:
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 use for clinical trial recruitment purposes of data that were originally collected for another business purpose raises several legal and regulatory questions, including whether health care providers may receive payment for permitting secondary uses of their data, the extent to which third-party payors, or agents of those payors, may be involved in research recruitment, and which entities may contact patients directly to discuss possible enrollment in a clinical trial. During this session, roundtable participants discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.
The R3 meeting took place on Thursday, March 7, from 10:00am – 3:00pm at the Washington, D.C. offices of Ropes & Gray LLP.
For more information, please email at MRCT@BWH.HARVARD.EDU
