While drug developers over the past six years have stepped up the number of post-marketing studies they conduct on newly approved medicines, sponsors feel that those studies have contributed little to their understanding of safety, efficacy, or quality, a recently completed assessment by the Tufts Center for the Study of Drug Development shows. According to a Tufts CSDD survey, 68 percent of clinical study sponsors and 79 percent of non-clinical study sponsors said results contributed either marginally or not at all to their understanding of the safety, efficacy, or quality of their product. However, 32 percent said clinical studies significantly or very significantly increased their understanding of their products.
"A lot of progress has been made in the area of post-approval studies since 2001, when the U.S. Food and Drug Administration regulation requiring sponsors to provide annual reports on the status of post-marketing studies went into effect," said Tufts CSDD Associate Director Christopher-Paul Milne. "But a major challenge drug sponsors face is completing the studies on time."
- here's the release on the study review