See All Focus Areas

Global Regulatory Engagement

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.

Graphic_Global_reg_mission

Current projects in this area include:

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

India Regulatory
In 2013, Indian regulators moved towards implementing a series of clinical trial regulations that had significant impact on the Indian clinical research industry. Since then, the MRCT Center has worked closely with governmental officials, industry stakeholders, and others to develop alternative reforms that would reinvigorate the industry and ensure the welfare of trial participants.  Read more

Real World Evidence 
In partnership with Optum Labs, the MRCT Center launched project OPERAND (Observational Patient Evidence for Regulatory Science And uNderstanding Disease) to develop empirical evidence for the use of real world data studies for regulatory science and medicine. The MRCT Center is also working with the Duke-Margolis Center on the Real World Evidence Collaborative. Read More