Global Regulatory ENGAGEMENT

Context

Regulatory issues in different countries and in different regions of the world impact the conduct, efficiency, and oversight of clinical trials. 

Challenge

There is a need for targeted engagement with regulators and influential thought leaders to develop trusted partnerships with a shared mission of improving the ethics, design, conduct, and oversight of multi-regional clinical trials.

MRCT Center Projects

Our approach has been to work with representatives of the global clinical trial ecosystem to identify major issues in international clinical trial practice. We strive to promote a country-specific and culturally-relevant approach: the global perspective is important to the mission of the MRCT Center.

projects in this area include:

Promoting Global Clinical Research in Children: Aligning Ethical, Pragmatic, and Regulatory Approaches
Given the practical challenges of executing multi-regional clinical trials, the regulatory challenges of working across jurisdictions, and the ethical challenges of enrolling children in research, global innovation in pediatric drug development is lacking. The MRCT Center is convening a workgroup of diverse stakeholders from academia, industry, regulatory agencies, not-for-profit organizations, trial networks, patients and patient advocacy organizations, and existing pediatric research initiatives to create a comprehensive set of harmonized tools for global pediatric research. Read more

Impact of GDPR on Clinical Research
The European Union’s General Data Protection Regulation (GDPR) took effect on May 25, 2018. The regulation focuses on the processing of personal data of individuals located in any member state of the European Economic Area (EEA). The GDPR applies extraterritorially in a broad range of circumstances and has disrupted US-based research. The MRCT Center is leading an effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health. Read more

Real World Evidence 
In partnership with Optum Labs, the MRCT Center launched project OPERAND (Observational Patient Evidence for Regulatory Approval and uNderstanding Disease) to develop empirical evidence for the use of real world data studies for regulatory science and medicine. After securing funding, two separate institutions, Brown University and Harvard Pilgrim Health Institute, were selected to replicate two trials. In addition, the MRCT Center worked with the Duke-Margolis Center on the Real World Evidence Collaborative to define a framework to establish best practices for utilizing RWE for regulatory decision-making. Read More

India Regulatory
Since 2013, the MRCT Center has worked closely with Indian leaders to determine tractable solutions to regulatory reform issues, many of which have deterred both for-profit and not-for-profit sponsors from conducting trials in the country.  Read more

China Clinical Regulatory Program
Beginning in early 2015, the MRCT Center, in collaboration with Peking University, developed scientific principles upon which to ground decision-making for MRCTs. A focused effort on training has continued to drive efforts in China.   Read more