Review of current authorship guidelines and the controversy regarding publication of clinical trial data.
Publication of clinical trial data is the final step in the scientific method and an important method by which pharmaceutical and biotechnology companies, i.e., drug sponsors, disseminate information about their products. Because of the nature of large, multicenter trials, multiple investigators from many institutions may be considered as authors of these papers. Controversy concerning the rights of academic institutions and the rights of drug sponsors has been widely debated. This chapter summarizes the controversy and the current policies.
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MaryAnn
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Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. mfoote@amgen.com
D001319:Authorship; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods / Q000592:standards*; D003142:Communication; D004282:Documentation / Q000941:ethics / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D010067:Ownership / Q000331:legislation & jurisprudence / Q000592:standards*; D010506:Periodicals as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D011643:Publishing / Q000941:ethics / Q000592:standards*; D015871:Scientific Misconduct; D014481:United States