Our projects span across our five 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.
Training
APEC Pilot Center of Excellence
The MRCT Center received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection.
Ethical Frameworks
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.
Data Transparency
Return of Individual Results
The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project will focus on returning individual results to study participants.
Global Regulatory
India Regulatory
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Training
Clinical Research Professional Competency
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Ethical Frameworks
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
Ethical Frameworks
MRCT Bioethics Collaborative
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Data 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 and to returning individual results.
Data Transparency
Data Sharing & Transparency Initiative
Defining and realizing a vision of developing an international non-profit entity to promote, coordinate and facilitate clinical trial data sharing, access and transparency.
Global Regulatory
China Global Regulatory Program
Providing scientific justification for when the utilization of a multi-regional clinical trial is sufficient to demonstrate safety and efficacy in a particular population.
Training
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).
Training
Drug & Vaccine development
Providing training of the decisions made throughout the drug and vaccine development process .
Training
Pharmacovigilance training
Providing training to understand how to effectively monitor for risks of medicines after approval.
Training
Research ethics guidance
Providing training in research ethics that incorporates a solid philosophical framework with practical case studies .
Training
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.
Data Transparency
Global Clinical Research Data
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.
Ethical Frameworks
Informed Consent
Disseminating templates for informed consent forms and data use agreement for broad data sharing purposes to use prospectively.