Protocol Design Optimization Is Starting to Improve, According to Tufts CSDD

Efforts by drug companies to streamline and improve the execution of clinical study designs-to counter mounting costs and shorten development times associated with bringing new drugs to market-are yielding positive benefits, according to an assessment recently completed by the Tufts Center for the Study of Drug Development and reported in the September/October Tufts CSDD Impact Report.

According to Tufts CSDD, greater emphasis by drug sponsors on upfront planning and governance to assess and challenge protocol feasibility and new approaches to development, including facilitated review mechanisms and greater use of adaptive trial designs, are helping to improve data quality and success rates, while cutting costs. Other findings from the analysis, include the following:

• On average, approximately one-quarter of a total study budget's direct costs was dedicated to procedures that collect non-core data.

• Although non-core data do not support primary and key secondary endpoints, sponsor companies include the non-core data they collect in 92% of their clinical study reports and in 95% of the tables, listings, and figures included in their regulatory submissions.
• Sponsor companies use simple adaptive trial designs, including early terminations and sample size re-estimations, in 21% of active clinical trials to improve success rates and reduce operating costs.

Read the full release here.