Risk-Sharing Lengthen Drug Development Timelines

Tufts CSDD: Risk-Sharing Lengthens Drug Development Timelines

Drug development programs that involve several partners who share clinical development risks accounted for about half of all new therapeutic drug approvals in recent years and experienced longer clinical phase times, as well as longer overall time to approval, according to a study recently completed by the Tufts Center for the Study of Drug Development.

According to the study, mean clinical phase time was 8.9 months longer for new drugs in multi-firm, risk-sharing clinical development relationships, and total (clinical plus regulatory review) phase time was 9.5 months longer, compared to new drugs that did not involve these relationships.