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Archive for September 23rd, 2008

FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine

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