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ShareTEST Act to increase clinical trial result reporting
08/23/12
Earlier this month, Congressman Edward Markey introduced The Trial and Experimental Studies Transparency (TEST) Act (H.R. 6272). The legislation is a reflection of recent journal article results indicating that the results of clinical trials are not being publicly reported. A study published in Biomedical Journal (BMJ) found that only 22% of eligible clinical trials reported clinical trial results on the ClinicalTrials.gov data bank within 1 year of completion even though the FDAA Act of 2007 already made reporting results within 12 months mandatory. Another study reported that 30% of trials registered in ClinicalTrials.gov remained un-published in peer-reviewed journals over 4 years after the studies had been completed; indicating a significant loss of clinical data.
Therefore, the TEST Act requires that clinical trials must be registered in the ClinicalTrials.gov database no later than 30 days after approval by the NIH. In addition, results of the clinical trials must be reported in the registry no later than 1 year after the study has been completed - although the responsible party can file for a delay if the drug or device fits specific criteria (see original legislation below). This would also apply for all clinical trials completed outside the U.S. if the trial data will be used in a FDA application (PMA, 510(k), IND). A summary of the clinical trial database will be reported by the FDA and NIH yearly to the House and Senate to ensure compliance and monitor progress.