Jul 07, 2020
Meeting of the Research, Development, and Regulatory Roundtable (R3)

12:00 PM to 3:00 PM
Location: Virtual

Dec 04, 2019
MRCT Center Annual Meeting

8:00 AM to 5:00 PM
Location: Loeb House at Harvard University, Cambridge, MA

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.
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Nov 15, 2019
Diversity in Clinical Trials In-Person Workgroup Meeting

8:00 AM to 5:00 PM
Location: Harvard Faculty Club, Cambridge, MA

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. > MORE

Nov 12, 2019
Credit for Data Sharing Webinar

11:00 AM to 12:00 PM
Location: Webinar

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. > MORE

Nov 07, 2019
Meeting of the Research, Development and Regulatory Roundtable (R3)

10:00 AM to 3:00 PM
Location: Washington, D.C.

Discussion topics: (1) Regulatory Challenges for Decentralized Clinical Trials, (2) Revised Common Rule. > MORE

Oct 21, 2019
Health Literacy Website Launch – Webinar

12:00 PM to 1:00 PM
Location: Webinar

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.  > MORE

Oct 17, 2019
MRCT Center Bioethics Collaborative

10:00 AM to 3:00 PM
Location: Ropes & Gray, Boston, MA

Discussion topic: Exploring the Ethics of Complex Clinical Trials > MORE

Aug 01, 2019
Meeting of the Research, Development, and Regulatory Roundtable (R3)

9:00 AM to 2:00 PM
Location: Ropes & Gray, Boston, MA

Discussion topics: (1) Exporting from China for Research: Biospecimens, DNA and Data, and (2) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies. > MORE

Jun 25, 2019
Presentation at DIA Global Annual Meeting

4:15 PM to 5:30 PM
Location: San Diego, California

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”

May 22, 2019
Presentations at AAHRPP Conference

7:00 AM to 6:30 PM
Location: The Ritz Carlton, New Orleans

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.

May 03, 2019
Launch of Proactive Safety Surveillance Project

8:30 to 4:30
Location: Ropes & Gray LLP, Boston, MA

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.

May 02, 2019
MRCT Center Bioethics Collaborative: Impact of Mobile Devices & Wearable Technologies on the Design and Conduct of Clinical Research

10:00 AM to 3:00 PM
Location: Ropes & Gray LLP, Boston, MA

The widespread use of mobile smart devices and wearables has the potential to drastically change how clinical research is conceptualized and conducted. > MORE

Mar 07, 2019
Meeting of the Research, Development, and Regulatory Roundtable (R3)

10:00 AM to 3:00 PM
Location: Ropes & Gray LLP, Washington, DC

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. > MORE

Feb 26, 2019
Health Canada ICH GCP and MRCT Training

9:00am to 5:00pm
Location: John G. Diefenbaker Building (Old City Hall) –111 Sussex Drive, Ottawa, Ontario

The MRCT Center will be facilitating didactic and case-based learning, presentations, and open discussion for regulators from Health Canada (reviewers and inspectors), and individuals from industry, academia, and non-profit organizations > MORE

Jan 22, 2019
MRCT Center Bioethics Collaborative: Impact of Social Media on Clinical Trial Integrity

10:00 AM to 3:00 PM
Location: Ropes & Gray LLP, Boston, MA

Over the last decade, social media has emerged as a medium for conducting research, recruiting and engaging participants, and enabling participants to interact with each other online. > MORE

Jan 07, 2019
Breakfast Roundtable Discussion Regarding GDPR and Clinical Research with Paul Mills from the UK’s NHS Health Research Authority

9:30am to 11:00am
Location: Ropes & Gray LLP, San Francisco, CA

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.  > MORE