Drug developers implementing new strategies for use of clinical trial comparator drugs

Drug developers are aggressively implementing new strategies to improve their access to and use of comparator drugs, which are used in clinical trials to determine how development candidates compare to existing therapies, according to leaders from the research-based drug industry who recently participated in a roundtable discussion convened by the Tufts Center for the Study of Drug Development.

"The challenges obtaining the right drugs for clinical trials-in the right quantity at the right time, and at the right price-are formidable," said Tufts CSDD director Kenneth Kaitin, adding: "The lack of fully robust supply chain management practices, growing emphasis on expensive biologics, changing regulatory requirements, and growth of counterfeit medicines are forcing drug sponsors to rethink and redesign their comparator drug supply chains to support drug development that, increasingly, crosses international borders."

Despite these hurdles, Mr Kaitin noted, the industry has embraced pro-active approaches, including improvements in communication between internal R&D and commercial operations, and a willingness to sell commercially available products to other developers, which are bearing fruit.