Informing the Update of ICH E6

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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).


Through a global, multi-stakeholder survey with 327 research professionals from 154 countries, in-depth interviews, and a public open comment period, CTTI determined that the areas requiring the most focus pertained to sponsors, essential documents, and investigators. This – along with co-hosting a public event with the FDA – is helping the ICH in its efforts to improve various topics within GCP.

Project Team Members

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