Dear AAU and Member Institutions:
As you all know, omitting or withholding data from the research record may constitute a form of research misconduct. Such omission might apply to the nonpublication of negative clinical trial results. When a decision is made to withhold rather than publish findings, the practice also falls squarely under the umbrella of conflict of interest, because the failure to publish negative results is directly attributable to the relationship between investigators, investigating universities, and industry sponsors. As a matter of institutional integrity, and in the interest of science and the public, AAU and its member institutions should be concerned about anything that undermines or distorts the scientific record on which further research, and important public health and policy decisions, is made.
I first learned about the problem of nonpublication of clinical trial results at an Institute of Medicine conference on conflict of interest in 2001 in a presentation by Tom Bodenheimer (with Steven Cummings) that presented published study data on missing and manipulated trial design from as early as 1986. Many institutions are aware of some of the more public cases, such as the Nancy Olivieri/University of Toronto case, or those that were exposed during the Vioxx scandal. But these are not isolated instances, as studies related to the responsible conduct of research increasingly affirm.
After more than 25 years, the long-running effort to make data about the outcomes of all clinical trials, regardless of findings, is gaining serious traction. The All-Trials Petition, managed by physician and science writer Ben Goldacre in coordination with the British Medical Journal and others, has now been signed by over 40,000 individuals from around the world, and hundreds of organizations, including the Royal Society of Medicine, Wellcome Trust, PLoS, American Medical Student Association, numerous physician groups/associations and rare/complex disease associations that need all information available, the Centre for Evidence-based Medicine, the British Medical Association and BMJ Group, BioMed Central, among many other domestic and international organizations (although I must say the U.S. is a little underrepresented). A major pharmaceutical firm, Glaxo Smith Kline, has signed.
The campaign’s motto is “All Trials Registered, All Results Reported.” No research institution worth that name could disagree with this call for an open and unbiased scientific record. It’s important.
The government is not enforcing an existing requirement to publish clinical trial results, and the problem continues to grow (here is an overview of the problem and extent of missing trial data). And right now is an appropriate time: Monday was International Clinical Trials Day.
So will you and your member institutions sign, AAU? And you too, NIH? You are on record, over and over, as supporting objectivity in science. Here is a chance to act on those assertions. Physicians, patients, the public that supports you in expectation of research integrity, the other researchers and companies that rely on the record, thank you in advance for your courage and commitment. Think how right it will feel to publicly support the real work of science—pursuit of the truth, wherever it may lead, whosever interest it turns out not to be in.
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