JAMA : the journal of the American Medical Association
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Biography Historical Article
Key witness against morning sickness drug faces scientific fraud charges.
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Historical Article
The existence of publication bias and risk factors for its occurrence.
Publication bias is the tendency on the parts of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or strength of the study findings. Much of what has been learned about publication bias comes from the social sciences, less from the field of medicine. In medicine, three studies have provided direct evidence for this bias. ⋯ If treatment decisions are based on the published literature, then the literature must include all available data that is of acceptable quality. Currently, obtaining information regarding all studies undertaken in a given field is difficult, even impossible. Registration of clinical trials, and perhaps other types of studies, is the direction in which the scientific community should move.
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Substantial numbers of clinical trials are never reported in print, and among those that are, many are not reported in sufficient detail to enable judgments to be made about the validity of their results. Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions. Investigators, research ethics committees, funding bodies, and scientific editors all have responsibilities to reduce underreporting of clinical trials. An extended use of prospective registration of trials at inception, as well as benefiting clinical research in other ways, could help people to play their respective roles in reducing underreporting of clinical trials.
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To gain a better understanding of the problem of dealing with publications whose integrity is subsequently challenged, experience in a well-documented case of research fraud was reviewed. At the University of California San Diego, a faculty committee evaluated 135 publications of Robert Slutsky, MD, and reported to each of the corresponding 30 journals whether each article was valid, questionable, or fraudulent, requesting publication of the criteria and the conclusions. Journals responded slowly to this request; half required additional letters over a 2-year period to elicit a reply. ⋯ Journals' inconsistent identification of published statements made it difficult to retrieve them by electronic searching. Only 7 notices covering 15 articles were found by searching under the Medical Subject Heading "Retraction of Publication"; scanning the entire bibliography retrieved 18 articles with retraction notations. A poll showed that journals rarely have written procedures for responding to allegations of research misconduct; in our experience, journals were reluctant to accept authorized retractions or corrections when coauthors failed to act.