The Center for the Study of Drug Development at Tufts University has published the results of a survey revealing that over two thirds of postmarketing study sponsors believe that the study results contributed either marginally or not at all to their understanding of the safety, efficacy, or quality of their product.
The results also revealed that 45% of studies are delayed beyond the projected completion date due to enrolment problems, technical difficulties, additional regulatory authority requirements or changes to the scope of the study.
In America, over half of all postmarketing studies are voluntarily initiated by the drugs industry with less than a quarter being requested by regulatory agencies as a condition of approval.
Given the apparent lack of value placed on these studies and the voluntary nature of the majority of these studies it is easy to see why many believe that these studies are designed to encourage greater use of new drugs rather than to genuinely provide greater understanding of the safety, efficacy, and quality of the study drug.
Action: Clinicians who participate in research work should carefully consider the study criteria for each study to ensure the research is appropriate and valid before agreeing to participate in the research.
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