News

JAMA relaxes requirements on industry sponsored studies

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f4121 (Published 25 June 2013) Cite this as: BMJ 2013;346:f4121
  1. Michael McCarthy
  1. 1Seattle

The journal of the American Medical Association, JAMA, will no longer require independent statistical analyses of industry sponsored studies by an academic biostatistician.

The journal adopted the requirement in 2005 “during a time when several high-profile trials had evidence of problems with data integrity, inappropriately conducted statistical analyses, and incomplete reporting of major findings,” wrote the journal’s editor, Howard Bauchner, in an editorial announcing the new policy posted online 20 June.1

Under the 2005 policy, studies sponsored by the drug industry in which data were analysed only by statisticians employed by the company sponsoring the research would not be accepted unless an additional independent analysis had been carried out by statisticians at an academic institution, such as a medical school, or a government research institute.

At the time the journal’s editors wrote, “We recognize that this requirement for an independent statistical analysis of industry-sponsored studies entails additional effort, time, and cost, but in our view, this additional verification of the data and the analyses, as well as an additional layer of institutional oversight for these studies, are essential.”2

In announcing the change in policy Bauchner pointed to a number of changes in the reporting of clinical trials, including the introduction of clinical trial reporting guidelines, greater access to trial protocols and statistical analytic plans, and proposed regulations requiring that companies seeking new product approvals provide complete access to clinical trial datasets.

“Collectively these changes have led to a substantial improvement in reporting, assessment, and transparency of clinical trials,” Bauchner wrote.

The old policy had “been perceived by some in academia and industry as creating barriers to publication of important trial results,” Bauchner wrote. “Moreover, over the past 2 years, our experience has been that the conduct of additional analyses by independent academic biostatisticians generally did not result in meaningful changes in the study results.”

“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,” he wrote.

Notes

Cite this as: BMJ 2013;346:f4121

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