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