Keeping an eye on NCCAM research may become easier if new NIH policy adopted

According to JAMA,  a recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completing the research.  Why? 

The scientific community has a disappointing track record for dissemination of clinical trial results. Numerous factors may contribute to these poor publication rates, including some that are beyond the control of researchers. Despite the best efforts of investigators, the results of some trials may never reach the threshold deemed necessary to merit the attention of journal editors and readers.

A big step forward in clinical trial transparency was made in November when the Department of Health and Human Services and the National Institutes of Health published proposals requiring researchers to report the results of certain trials at ClinicalTrials.gov.  

 

HHS (which has jurisdiction over the FDA) proposed new rules. The NIH proposed a new policy.  Each has a different scope.  HHS's rules apply to certain interventional studies of drugs, biological products, and devices that are regulated by the FDA.  A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products. Of course, both positive and negative results must be reported.  This should cut down on the unnecessary duplication of research which occurs when researchers don't know the results of other trials that could impact their own.  

Of particular interest to fans of science-based medicine is the proposed rules' application to biologics, which includes stem cell therapy.  David Gorski (also here), Steve Novella and I have all blogged about the extravagant claims for some stem cell therapies.  Because there is a dearth of published research, and because so few of these therapies have been approved by the FDA, any knowledge that adds to the publicly-available database is welcome.  It won't stop all patients from stem cell tourism and its promise of miracle cures, but it can't hurt either.  

But the real news for the science-based medicine fan is the NIH's proposed policy. The NIH wants to require that results of all clinical trials funded by the NIH be reported at ClinicalTrials.gov.  

This Policy applies to all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by NIH, regardless of study phase, type of intervention [or whether the intervention is subject to FDA jurisdiction]. For purposes of this Policy, a clinical trial is defined as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."

This means that NCCAM-funded research would be subject to the reporting requirements if it fell within these fairly broad parameters.  All dietary supplement research, all acupuncture research, all "mind-body" research.  All research at chiropractic, naturopathic and acupuncture schools.  If it's funded in whole or in part by NCCAM, it must be reported.  

NCCAM's website focuses on published research.  Who knows how many tax dollars were given out to fund research that never saw the light of day, in the form of publication or reporting on ClincalTrials.gov. Or anywhere else, for that matter.  The policy is not retroactive, as far as I can tell, but I sure wish it were. 

Not that negative results would make any difference to CAM practitioners or their allies.  Even the most implausible of interventions with published results of ineffectiveness have been adopted by "integrative" medicine centers with otherwise stellar reputations. 

I was particularly struck, in this context, by one of the rationales used to support the new reporting requirements.  

“Medical advances would not be possible without participants in clinical trials,” said NIH Director Francis S. Collins, M.D., Ph.D. “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.”

How true.  Unfortunately, the entire rationale for NCCAM -- that it exists to "validate" alternative medicine -- is necessarily a deviation from that laudable commitment.  No one is going to benefit from research into interventions that are doomed from the start by their utter implausibility.  At least now, if the proposed policy is adopted, "maximal use of this knowledge" can perhaps be achieved by yet another confirmation that acupuncture and reiki, for example, aren't effective.  It might not stop integrative medicine centers from employing it, but maybe the negative studies will make good blog posts.  

If you'd like to put in your two-cents worth, according to the NIH:

Written comments on the proposed NIH Policy should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at This email address is being protected from spambots. You need JavaScript enabled to view it., mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or by fax at 301-496-9839. The agency will consider all comments in preparing the final rule and final NIH Policy.

 

 

Points of Interest 12/29/2014
Points of Interest 11/27/2014

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