Many clinical trials in the US are failing to report their findings in a publically available database, says a study by researchers at the University of Nottingham, published in the British Medical Journal (BMJ). This is despite a recent law that makes such a reporting mandatory.
The study was carried out by Dr. Andrew Prayle, Dr Matthew Hurley and Prof. Alan Smyth in the University's Division of Child Health. It showed that out of the studies completed in the US during the course of 2009, less than one-quarter had logged their results on the ClinicalTrials.gov website.
A key principal of best practice in the conduct of clinical trials is that a summary of the trial should be freely available while the study is ongoing. On completion, the results should also be easily and quickly accessed. However, until recent times, there was no legal obligation for scientists to offer access to the results of their trial, many of which go unreported by scientific or medical journals.
The US is seen to have led the way in legislation to make clinical trials more transparent. In February 2000, the Food and Drug Administration (FDA) Modernization Act prompted the creation of a national clinical trials registry, ClinicalTrials.gov. The FDA Amendments Act (FDAAA) of 2007 made it a mandatory requirement for the registration of trial result summaries within a year in most cases. This applies to studies that have at least one site in the US, are of a drug, device or biological agent and had started or were ongoing as of September 2007. This legislation was expected to revolutionise access to clinical trial data, as it is free for all to access.
To check compliance with the US law, the Nottingham team selected trials subject to mandatory reporting within one year which were completed between January 1 and December 31, 2009. The timeframe was chosen because all the studies completing within the year would have had at least one year to report results.
They then cross-referenced the investigational drug for each of the applicable clinical trials with the FDA database of approved drugs, Drugs@FDA. They found that out of 738 trials that were classified as subject to mandatory reporting, just 163 (22 percent) 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. A positive effect of the legislation was noted — where trials did not fall under the legislation only 10 percent of them had reported results.
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