It’s Time to Harmonize Clinical Trial Site Standards

S. Claiborne Johnston, MD, PhD, Dell Medical School, University of
Texas, Austin; Freda Lewis-Hall, MD, DFAPA, Pfizer Inc.; Arti Bajpai,
MBA, Compliance and Quality Integration Consulting; Tracy Harmon
Blumenfeld, MBA, RapidTrials; Peter Goldschmidt, MD, DrPH, DMS,
Health Improvement Institute; Greg Koski, MD, PhD, Alliance for
Clinical Research Excellence and Safety; Grace Lee, Health Enovation,
Inc.; Roslyn Schneider, MD, MSc, Pfizer Inc.; Pamela Tenaerts, MD,
MBA, Clinical Trials Transformation Initiative; Andrew Womack, PhD,

October 9, 2017

ABSTRACT | Climbing costs and lengthy time frames of clinical trials are significant
bottlenecks in medical product development. Despite the fact that scientific discoveries
yield many new possible targets for developing into therapies, the capacity
and resources with which to develop these targets are limited, thereby leaving potentially
valuable discoveries undeveloped and unrealized. Under the aegis of the
Clinical Trial Site Standards Harmonization Action Collaborative (“the Collaborative”)
of the Forum on Drug Discovery, Development, and Translation of the National
Academies of Sciences, Engineering, and Medicine, clinical research stakeholders
set out to discuss opportunities to improve clinical trial site functioning, with the
goal of increasing productivity in medical product development. Our conclusion:
harmonization of standards for clinical trial sites has significant promise in improving
clinical trials. Standards would also be essential to the formation of a site accreditation
system in the United States, should a consensus emerge on the need
for such a system. This paper synthesizes the results of the work conducted to
inform discussions of the Collaborative. This paper may serve as a launching point
for harmonizing requirements applied to clinical trial sites and the development of
standards. A clinical trial infrastructure that reduces redundancies and increases efficiencies
would, in turn, accelerate the pace and productivity of new product development,
to the benefit of patients and society.