MRCT Projects

Projects

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.

Ethical Frameworks

Protocol Ethics

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

Post-Trial Responsibilities

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.

Ethical Frameworks

MRCT Bioethics Collaborative

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 Individual Results

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.

Data Transparency

Return of aggregate results

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

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

India Regulatory

India Regulatory

Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.

Global Regulatory

China Global Regulatory Program

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

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

APEC Pilot Center of Excellence

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.

Training

Clinical Research Professional Competency

Clinical Research Professional Competency

Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.

Training

Drug & Vaccine development

Drug & Vaccine development

Providing training of the decisions made throughout the drug and vaccine development process .

Training

Pharmacovigilance training

Pharmacovigilance training

Providing training to understand how to effectively monitor for risks of medicines after approval.

Training

Research ethics guidance

Research ethics guidance

Providing training in research ethics that incorporates a solid philosophical framework with practical case studies .

Training

Causality 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

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

Informed Consent

Disseminating templates for informed consent forms and data use agreement for broad data sharing purposes to use prospectively.