The U.S. Department of Health and Human Services (HHS) and consulting firm Eastern Research Group, Inc. (ERG) leveraged Medidata’s Clinical Cloud for research-driven analysis on costs related to the design and execution of clinical trials. Recently published in the edition of Clinical Trials: Journal of the Society for Clinical Trials, the analysis identifies different factors, such as therapeutic area, patient recruitment, administrative staff, and clinical procedure expenditures, and their contribution to pharmaceutical clinical trial costs in the U.S. by clinical trial phase.
 
HHS and ERG utilized Medidata’s databases of negotiated investigator grants (PICAS available through Medidata Grants Manager and CROCAS available through Medidata CRO Contractor). The databases currently contain information from more than 331,000 negotiated site grants and contracts and 30,000 protocols in nearly 2,000 indications. Based on this comprehensive data, the research revealed that therapeutic area as well as number and types of clinical procedures involved are the key drivers of costs in Phase I through Phase III studies.

Key research findings cited the therapeutic area with the highest combined average per-study costs across Phases I, II and III is pain and anesthesia ($71.3 million), followed by ophthalmology ($49.8 million) and anti-infective ($41.2 million) trials. Trials in dermatology, endocrinology, and gastroenterology have the lowest overall costs. Overall, the top cost drivers of clinical trials across all three trial phases include clinical procedures (15 to 22%), administrative staff (11 to 29%) and site monitoring (9 to 14%).
 
Aylin Sertkaya, vice president, ERG, said, “As the industry’s largest repositories of real-world negotiated trial costs, Medidata’s databases were vital to our research efforts. Analyses such as this support our goal of driving impactful change for the life sciences industry and the patients it serves.”
 
“Medidata shares HHS and ERG’s commitment to advancing clinical development so that safe new therapies can reach patients sooner,” said Mike Capone, Medidata’s chief operating officer. “We’re proud that the rich data assets available through our platform supported this important research initiative, which will guide new strategies that help the industry transform drug development by optimizing clinical trial processes and reducing their costs.”