Our projects span across our four focus areas, with a focus on our mission – to engage diverse stakeholders in global clinical trials and to create and implement ethical, actionable, and practical solutions.
Transparency
Academic Credit for Data Sharing
Developing criteria and systems for recognition of generators of data in a way that is meaningful, appropriate, standardized, and accepted by researchers, academic institutions, journals, and funders
Ethics, Conduct, and Oversight
Advancing the Quality of Clinical Trial Enterprise
Improving the design and the quality of clinical trial reporting will result in a reduction in the number of non-informative trials that are initiated.
Transparency
Balancing Data Anonymization with Data Utility
Defining key principles of data protection and anonymization and working towards international harmonization of standards to enable clinical data sharing
Ethics, Conduct, and Oversight
Bioethics Collaborative
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Capacity Building
Causality training
Providing training to ensure those tasked with adjudicating causality are up-to-date on latest methods in causality determination and have practical scenarios.
Capacity Building
Data monitoring committees
Identifying, recruiting and training leaders from emerging regions who have expertise in medicine or statistics and experience in clinical trials, to equip them to serve on Data Monitoring Committees (DMCs).
Ethics, Conduct, and Oversight
Diversity, Inclusion, and Equity in Clinical Research
Developed a systematic guidance document and supplementary toolkit to enhance diversity in multi-regional clinical trials
Capacity Building
Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
Global Regulatory Engagement
Global Regulatory Engagement
Working closely with international regulators to determine tractable solutions to regulatory reform issues.
Ethics, Conduct, and Oversight
Health Literacy in Clinical Research
A collaborative project to support the development of tools and resources that more fully incorporate health literacy concepts into clinical research materials created for participants.
Global Regulatory Engagement
Impact of GDPR and Privacy Laws on Clinical Research
An effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health
Capacity Building
Joint Task Force for Clinical Trial Competency
Promoting a set of harmonized competencies for training and qualification purposes of clinical research professionals.
Ethics, Conduct, and Oversight
Post-Trial Responsibilities
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.
Ethics, Conduct, and Oversight
Proactive Safety Surveillance: A Global Approach
Improving upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s).
Global Regulatory Engagement
Promoting Global Clinical Research in Children
Identifying and advancing ethical approaches, guidance, and actionable tools to enable effective enrollment in pediatric studies and responsibly analyzed, interpreted and communicated data.
Ethics, Conduct, and Oversight
Protocol Ethics
Providing systematic guidance for protocol writers to address ethical considerations in planned clinical trials and for ethics committee members to ensure study protocols have adequately addressed ethical issues
Global Regulatory Engagement
Real World Evidence
Investigating the reliability of evidence from retrospective database studies of medical claims and electronic medical records by engaging diverse stakeholders to determine study design
Ethics, Conduct, and Oversight
Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP
Ethics, Conduct, and Oversight
Resources for Patients and Participants
Accurate health and research information from trusted, reliable sources is needed. The MRCT Center created a website specifically for patients, potential participants, and the public.
Transparency
Return of Aggregate Results
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture
Transparency
Return of Individual Results
Providing Principles, Recommendations Document and Toolkit for returning individual results to study participants
Transparency
Tools for Data Sharing
Developing harmonized governance tools for data sharing, enhance data transparency and collaboration, reduce administrative barriers, shorten the time to new discovery
Transparency
Global Clinical Trial Data Sharing
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.