We gratefully acknowledge Hui-Hsing Wong (ASPE) and Amber Jessup (ASPE) for their leadership, guidance, and input throughout this study. We also would like to thank Patrick Archdeacon (FDA) and Trini Beleche (FDA) for their insightful comments and advice. Medidata Solutions provided the data for the analysis of clinical trial costs. We would like to thank Lori Shields, Frank Cattie, Rafael Campo, and Joshua Hartman at Medidata Solutions for accommodating our data requests and answering our questions.
We also would like to acknowledge the contributions of our subject matter experts, Michael Silverman, Sheldon Brookman, and David Bristol (independent consultants to ERG) to formulating our interview questions and the clinical trial decision-making parameters.
Many people involved in clinical research, including pharmaceutical/biopharmaceutical company representatives, CRO personnel, and industry experts, provided valuable information for the study. We are grateful to all of them for sharing their expertise and experiences with us.
This report was prepared by ERG, under contract to the Assistant Secretary for Planning and Evaluation. The findings and conclusions of this report are those of the author(s) and do not necessarily represent the views of ASPE, FDA or HHS