Life Science Compliance Update

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July 17, 2013

JAMA Drops Requirement for Independent Statistical Analysis for Industry Funded Trials

The Journal of American Medical Association dropped its requirement for independent statistical analyses of industry-funded clinical trials. Editor-in-Chief Howard Bauchner, MD, cited improvements in the quality of clinical-trial reporting for making the 8-year-old policy unnecessary.


Bauchner notes that changes in the reporting of clinical trials over the last decade have addressed threats to the validity of research. "In addition, more widespread availability and detailed review of trial protocols and statistical analytic plans has helped clarify the intention of investigators at the time studies are designed, and along with gradual increases in the amount of data sharing, have facilitated the ability of reviewers and journal editors to assess the scientific validity of studies," said Bauchner.


In 2005, The Journal of American Medical Association adopted policies addressing: "conflicts of interest, financial aspects of research, and the role of sponsors in funded research." The policies required that an academic biostatistician conduct independent statistical analysis for industry-sponsored and industry-analyzed studies. The policy was created in response to several high-profile trials that had problems with: "data integrity, inappropriately conducted statistical analysis, and incomplete reporting of major findings."


Some in academia and industry viewed the policy as a barrier to the publication of trial results. In addition, Bauchner notes over the past two years, the Journal has found: "the conduct of additional analyses by independent academic biostatisticians generally did not result in meaningful changes in the study results."


Bauchner cites: "Advances over the past decade in standards of clinical trial reporting, enhanced understanding of the threats to validity of clinical research, increasing data transparency, and our experience support the change in policy." Now, the Journal: "will evaluate and consider for publication clinical trials that are analyzed by statisticians employed by or contracted by the study sponsor, without requiring independent statistical analysis by an academic biostatistician."


The Journal will continue other requirements, including the submission of a copy of the trial protocol and statistical analytic plan with amendments, and trials must be registered with an approved publicly accessible database. Changes to the protocol, analysis plan, or trial registration that occur after the beginning of the trial must be explained in detail and justified with appropriate documentation. Further, if Journal editorial reviews raise concerns: "we reserve the right to request the entire data set from authors to conduct our own statistical analysis," said Bauchner.


The Journal stands by its previous editorial stating a preference that investigators from academic institutions, as opposed to employees from the study's sponsor, prepare the manuscripts and analyze data from clinical trials. Bauchner stressed: "As with all manuscripts, the first priority in decisions about publication will always be the integrity of the research."


This change in standards verifies that company sponsored science is very high quality and that the additional requirement was unnecessary. When JAMA embarked on this additional requirement they had expected other journals to fall in line, but that did not happen.


Negative statements like the original requirement against industry sponsored trials has caused physicians to discredit industries trials and patients have suffered because of this. It is a pity that the JAMA retains the prejudice that studies written and analyzed by academia are by their nature superior to studies written and analyzed by industry. These religious believes run counter to science but at least they were honest enough to admit when they were wrong.


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