Show Us the Data

If a clinical trial is run, but the results are never published, what benefit is there to patients, physicians, or the public?

The British Medical Journal (BMJ) took on this topic by publishing several articles that demonstrate how haphazard and incomplete the public disclosure of clinical trial data is. The FDA Amendments Act of 2007 made publication of a results summary on ClinicalTrials.gov within 12 months of trial completion mandatory for all eligible trials in the US initiated or ongoing as of September 2007. In a paper published in the January issue of BMJ, Prayle and colleagues  looked at studies completed between Jan 1, 2009 and Dec. 31, 2009, and found that only 22% had been reported on ClinicalTrials.gov by January of 2011. A second article by Ross and colleagues looked at NIH-funded trials, and found that of 635 trials completed by December 2008, only 46% had been published in a peer-reviewed journal 30 months later.

The omission of data can affect how the remaining data are interpreted. Conclusions about a particular drug’s efficacy are sometimes based on meta-analyses, where data from several independent studies are integrated to get a better idea of treatment effects. A study by Hart and colleagues reanalyzed 41 meta-analyses of efficacy incorporating unpublished data from FDA, and found the outcome to be the same in only 3 cases.

In an accompanying editorial, Richard Lehman, senior research fellow in the department of primary care at the University of Oxford and Elizabeth Loder, clinical epidemiology editor at BMJ underscore the seriousness of these lapses. “We are not dealing here with trial design, hidden bias, or problems of data analysis-we are talking simply about the absence of the data,” they write. “And this is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems. Moreover, researchers or others who deliberately conceal trial results have breached their ethical duty to trial participants.”

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