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Rising Protocol Complexity Is Hindering Performance while Driving Up Cost of Clinical Trials, According to the Tufts Center for the Study of Drug DevelopmentBOSTON, July 17, 2018 (GLOBE NEWSWIRE) -- Rising protocol complexity is hindering clinical trial performance and efficiency, and helping to drive up the cost of developing new drugs, according to a recently completed analysis by the Tufts Center for the Study of Drug Development. "Protocol design scope and complexity have steadily increased, and this trend will continue—and likely accelerate—as pharmaceutical and biotechnology companies target more difficult-to-treat and rare diseases, enroll more stratified patient populations, and collect higher volume and more diverse data," said Ken Getz, associate professor and director of sponsored research at Tufts CSDD, who led the analysis. He said that in addition to increasing clinical costs and inefficiencies, current protocol design practices increase the burden on internal and external staff to execute trials and hinder study volunteer recruitment and retention rates. The analysis was based on an assessment of 9,737 protocols from 178 global pharmaceutical and biotechnology companies. Key findings stemming from the study, summarized in the July/August Tufts CSDD Impact Report, released today, included the following:
ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT Established in 1976, the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) is a multidisciplinary, academic research group that provides data-driven analyses and strategic insight to help developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers CME-accredited professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bimonthly newsletter focusing on critical drug development issues. Contacts: Tufts Center for the Study of Drug Development Business Communication Strategies |