Sponsors of postmarketing studies of new drugs believe such work has contributed little to their understanding. This is so despite the fact that drug developers have increased the number of postmarketing studies they conduct on newly-approved medicines over the past six years.
Such are the findings of a survey carried out by the Center for the Study of Drug Development at Tufts University in Boston, USA.
Researchers said 68% of clinical and 79% of non-clinical study sponsors told them postmarketing study results had contributed either marginally or not at all to their understanding of the safety, efficacy or quality of their new products, although 32% felt the studies had “significantly or very significantly” increased their understanding.
CSDD associate director Dr Christopher-Paul Milne said considerable progress had been made since FDA regulation requiring sponsors to provide annual reports on the status of such studies took effect in 2001, but a major challenge faced by drug sponsors was completing the studies on time.
The survey found that while more than half of all postmarketing studies for which final study reports were submitted were finished by their projected completion date, 45% were delayed due to enrolment problems, technical difficulties, additional FDA requirements or sponsors expanding the scope of their own studies.
Other findings included that: clinical studies took an average of 10 months longer to complete and cost nearly nine times as much as non-clinical studies; postmarketing studies are typically the responsibility of applicable R&D and not marketing departments, as some critics of the US Prescription Drug User Fee Act (PDUFA) have claimed; and during 1998-2005, drug sponsors spent an average of US$5.3m per clinical postmarketing study, compared to US$610,000 for each nonclinical study.