Project:

Informing ICH E6 Renovation

overview icon Overview

Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders. Recently, CTTI conducted research to help inform the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as it revises ICH E6 Good Clinical Practice (GCP).

 

As part of this work, CTTI conducted a global, multi-stakeholder survey with 327 research professionals in 20 different global regions on areas of GCP in need of renovation. Preliminary findings were presented to the FDA and EMA in advance of the first ICH E6 work group meeting in November 2019. A final report highlighting these findings was developed to help the ICH in its efforts to improve various topics within GCP.

Project Team Members

Role Namesort descending Affiliation
Social Science Lead Amy Corneli Clinical Trials Transformation Initiative
Project Manager Annemarie Forrest Clinical Trials Transformation Initiative
Team Member Fergus Sweeney European Medicines Agency
Team Member Fred Feldstein Johnson & Johnson/Janssen
Team Member James Riddle Quorum Review IRB
Team Member Janette Panhuis Population Health Research Institute-McMaster University
Team Member Ji-Eun Kim Northwell Health
Team Member Jiyoung Choi Northwell Health
Team Member Lawrence Calais Department of Veterans Affairs
Team Member Martin Landray University of Oxford
Team Member Maryam Sadat Amgen Inc
Team Member Melissa Bomben Syneos Health
Team Member Michele Russell-Einhorn Advarra
Team Member Pamela Gonzalez Department of Veterans Affairs
Team Member Patricia Hurley American Society of Clinical Oncology
Team Member Peter Marks Merck & Company, Inc
Team Member Sarah Mizrahi Medidata Solutions
Team Member Theresa Mullin Food and Drug Administration/CDER