The MRCT Center engages diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Defining and realizing a vision of developing an international non-profit entity to promote, coordinate and facilitate clinical trial data sharing, access and transparency.
Providing scientific justification for when the utilization of a multi-regional clinical trial is sufficient to demonstrate safety and efficacy in a particular population.
Providing training to ensure those tasked with adjudicating causality are up-to-date on latest methods in causality determination and have practical scenarios.
Developing an ethical framework and toolkit for addressing post-trial responsibilities related to access to investigational product, access to medical care, and access to infrastructure.
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture and to returning individual results.
Mar 30, 2016
Conference on the Future of Data Sharing
On March 21-22, 2016 at an invitation-only meeting at the Wellcome Trust in London, the MRCT Center and collaborators shared plans to launch a new not-for-profit organization, Vivli, charged with directing, implementing and governing a global clinical trial data-sharing platform. The plans for an approach whereby data from multiple sources can be integrated, enabling researchers […]
Mar 01, 2016
Launch of Bioethics Collaborative
The MRCT Center is launching a new initiative–the Bioethics Collaborative. The MRCT Bioethics Collaborative is a forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development. Our meetings will bring together scholars, executives, and scientists from academia and industry to share, define, study, and propose ethical […]
Feb 17, 2016
Proceedings, Presentations and Annual Report Available from MRCT Center’s 2015 Annual Meeting
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.
Discussion of real world applications, future revisions and future objectives for core competencies framework for clinical researchers.
Jul 12, 2016
Guidance for Medical Writers for Returning Aggregate Results -3rd Clinical Regulatory Medical Writing Forum
Carmen Aldinger, MRCT Center Program Manager, will be giving a presentation on “Guidance for Medical Writers for Returning Aggregate Results to Participants Using Lay Language” at the 3rd Clinical Regulatory Medical Writing forum on Tuesday, July 12 in Philadelphia.