A medical device or drug has gone a long way through its development before making it to the crucial clinical trial stage, and it has an even longer journey through the approval phase before doctors can treat patients with it. With so many components and resources going into each device submitted by an OEM, one might think that following the mandatory requirement of registering trial result summaries within a year would be closely followed in order to raise product interest, and therefore hopefully sales, but a study recently conducted by research fellows at the University of Nottingham (Nottingham, UK) published in the British Medical Journal shows that less than a quarter of U.S. clinical trials are posted in a publicly available database.
In an attempt to make clinical trials more transparent, the U.S. has led the way in creating legislation, such as the FDA Modernization Act of 2000, which created a national clinical trials registry. For studies of devices, drugs, or biological agents that have at least one site in the U.S., the FDA Amendments Act (FDAAA) of 2007 requires that in most cases trial result summaries are registered within a year. Since not all trials end up published in academic journals, the ClinicalTrials.gov website was created to allow researchers to publish clinical trial results for free.
In the study examining compliance rates, clinical research fellow Andrew Prayle and his colleagues selected trials that were subject to mandatory reporting completed between January 1 and December 31,2009. By cross referencing the investigational drug for each clinical trial with the Drugs@FDA database of approved drugs, the team found that just 163 of 738 trials subject to mandatory reporting had actually reported results, which is only 22 percent.
The study also showed that industry funded trials subject to mandatory reporting were far more likely to report results when compared to other funders, showing that there may be a considerable influence of the sponsor or funding body for compliance with the regulation. But the researchers found that the legislation may be increasing the number of reported trials since only 10 percent of trials not falling under the legislation chose to report results. The researchers noted that the legislation has only recently been enacted, and hope that result reporting will increase in the future.
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