Not Reporting Results of a Clinical Trial Is Academic Misconduct | Annals of Internal Medicine | American College of Physicians

peter.suber's bookmarks 2019-05-12


"Failure to report the results of clinical trials threatens the public's trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports” (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based on trust, that the evidence generated will inform clinical science (2). Health care providers and medical societies, who are responsible for evaluating and synthesizing evidence and filling the gap between research and practice, need for investigators to fully report their results in a timely manner. The utility of the diligent search for truth in the medical literature depends on its completeness. However, when research findings are not consistently disseminated, the literature provides a skewed view of the science, which may bias reviews of the evidence....

The conduct of research in humans comes with inviolable responsibilities, including the commitment to share what has been learned. No reason exists for the topline results of a clinical trial not to be made public. Failure to report is detrimental to the scientific process. When trial results are not publicly available for years after study completion, patients, institutional review boards, clinicians, researchers, and the public must rely on incomplete evidence, which may lead to misconceptions about the efficacy and safety of interventions. The time has arrived to address this threat to trust and science."


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Tags: oa.pharma oa.medicine oa.misconduct oa.ethics oa.paywalled

Date tagged:

05/12/2019, 10:34

Date published:

05/12/2019, 06:34