With PDUFA up for renewal, drugmakers are kvetching about some provisions, such as the one requiring post-marketing studies. In a not-so-subtle attempt to pooh-pooh the need for such things, the Tufts Centers for the Study of Drug Development, which gets a big chunk of its funding from industry, recently released a survey suggesting post-marketing studies are almost useless.
According to Tufts, 68 percent of clinical study sponsors said results contributed either marginally or not at all to their understanding of the safety, efficacy, or quality of their product. But 32 percent said clinical studies significantly or very significantly increased their understanding of their products.
More than half of all postmarketing studies, for which final study reports were submitted, were supposedly finished by their projected completion date, but 45 percent were delayed due to enrollment problems, technical difficulties, additional FDA requirements, or sponsors expanding the scope of their own studies.
In other words, why bother? Well, here's a good reason: properly designed follow-up studies may provide more safety and effectivness info. That's a worthwhile investment; not only does it build goodwill, it also may yield crucial insights that benefit public health. Drugmakers should stop whining. If studies are problematic, design better ones.
The analysis also found that:
* Clinical studies, on average, took 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 departments, not marketing departments; * Between 1998 and 2005 sponsors spent, on average, $5.3 million per clinical postmarketing study, compared to $610,000 per non-clinical study.
Source: Tufts CSDD