January 6, 2012

Many NIH-Funded Clinical Trials Go Unpublished

At first reading, my reaction was maybe the studies arrived at conclusions not looked for and maybe were not news or worthy of publication. With many studies that do make the press and even some that do make the journals being highly suspect, we do need to be aware that many more studies never see print because of poor results. Are our researchers so agenda driven that when a study does not obtain the desired results, they bury the results.

These are just a few of the questions that need to be asked. These studies were funded by taxpayer dollars and therefore should be published. Even if they are not news or worthy of publication, there are alternative methods for providing timely public access to study results, including the results database at Clinical Trials.gov that was created in response to Federal law.

The study, which appears in the January issue of the British Medical Journal, states that less than one-half of the trials funded fully or in part by the National Institutes of Health were published within 30 months of completion and that one-third of trials remained unpublished 51 months after completion. This is a very poor return on investment and if the results were actually unworthy of publication indicates that approval needs to be reviewed to prevent poorly premised studies from being funded.

Science Daily again published their second report on January 5 on the same study and this report is more telling in the lack of reporting the their article of January 3. “They found that out of 738 trials that were classified as subject to mandatory reporting, just 163 (22 per cent) had reported results. The study found that the influence of the funding body or sponsor seemed to be considerable -- industry funded trials subject to mandatory reporting were far more likely to report results compared with other funders. Importantly a positive effect of the legislation was noted -- where trials did not fall under the legislation only 10 per cent of them had reported results.”

Another argument voiced in the press release says that when research findings are not disseminated, the scientific process is disrupted and allows redundant studies to be funded. Not only does this permit a waste of funds available for research of many pressing studies, but also it has far-reaching effects for policy decisions and even institutional review board assessments of risks and benefits associated with future research studies.

We all know that non-publication and delayed publication (and even burying of results) happens for studies and trials funded by the pharmaceutical and medical device industries, as well as by non-profit organizations. While the authors state more work needs to be done to understand the problems leading to publication, no mention is made of why poorly designed studies are allowed to be funded in the first place and the results buried when the researchers arrive at conclusions other than what they wanted. A procedure for determining who receives funding also needs a thorough review.

Then January 4, 2012 from the NIH makes this announcement “National Institute of General Medical Sciences reorganizes.” Make one wonder if they are taking this study seriously. This is highly doubtful as is clearly stated here, “The amount of money allocated to programs in the new divisions will not change as a result of the reorganization or transfer of NCRR programs. Most grants in the new divisions will continue to be managed by the same staff members.”

Will we see changes in publishing of studies? Highly doubtful! Just more layers of governmental bureaucracy.

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