The MRCT Center 2018 Annual Meeting was held on December 5, 2018 and convened a diverse group of approximately 80 stakeholders focusing on global clinical trials.
The principal topics discussed at the MRCT Center 2018 Annual Meeting were: (1) European Union General Data Protection Regulation (GDPR), (2) Representation of Diverse Populations, (3) Advancing the Study of Clinical Trials, (4) Capacity Building, and (5) Health Literacy in Clinical Research.
On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
Transparency has been a special focus of the MRCT Center’s 2016 efforts. We introduced detailed plans for Vivli – an independent Center for Global Clinical Research Data – and we developed a principled framework for the return of individual research results to study participants. The 2016 Impact Report also highlights our work on harmonized core competencies for clinical research professionals, post-trial responsibilities, Bioethics Collaborative, and global regulatory efforts in India and China.
The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.
The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency. The Post-Trial Responsibilities (PTR) Working Group developed an Ethics Framework with two main deliverables: a PTR Guidance Document and a PTR Toolkit. Invited speakers shared their perspectives and suggestions for revisions. The Data Sharing and Data Transparency Initiative’s current progress on developing a blueprint for a new, not-for-profit entity was presented. Invited speakers shared their perspectives on the project vision to date.
MRCT Center at Harvard 2014 Annual Meeting was held on 3 December 2014 and was attended by by more than 60 stakeholders from governmental agencies, pharmaceutical industry, academia, patient advocates, media representatives and others. MRCT Center at Harvard’s Annual Progress Report 2014 was released at the meeting.
The meeting focused on returning aggregate results to research participants. MRCT Center at Harvard faculty co-directors presented drafts of the Return of Results Guidance Document and Toolkit which was followed by perspectives from various stakeholders. In addition, the faculty co-directors gave an overview of MRCT Center at Harvard’s work in India addressing regulatory issues, causality determination, and compensation calculation. Presentations and Proceedings from this meeting are now available
