Summary
It is unclear where this debate is headed and how it will be resolved. It is important to remember that patients’ needs are quite different from the research community’s when it comes to clinical trial registries. The patient is interested in the number of different trials, the enrollment criteria, and the geographical proximity of the trial site so that he/she can make a decision about whether the trial is of potential interest. These are a mere subset of the 20 data elements that are under discussion and have little bearing on the transparency of clinical research that the remaining data elements are designed to address. p ]Finally, the role of the FDA must be fully recognized for what it is, an impartial review of all the data required to support a marketing application. Those who castigate the pharmaceutical industry indirectly impugn the integrity of the FDA. Pharmaceutical industry clinical research goes forward with the full knowledge that trial design and results will be critically examined. A product will not be licensed for marketing nor will an advertising claim be permitted unless the data support it.
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© 2006 Birkhäuser Verlag Basel/Switzerland
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Goldhammer, A. (2006). Transparency and validity of pharmaceutical research. In: Foote, M. (eds) Clinical Trial Registries. Birkhäuser Basel. https://doi.org/10.1007/978-3-7643-7583-6_7
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