Low reporting of clinical trial data in key US database, study shows - The ...
22.02.12
“Recent legislation in the USA requires some clinical trials to publish their results on the website within a year of the trial finishing. We cross-referenced the ClinicalTrials.gov database and another database called Drugs@FDA to identify trials which should have reported results, and found that around a quarter had uploaded results to the 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 and that, on completion of the study, 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 has lead the way in legislation to make clinical trials more transparent. In February 2000, the Food and Drug Administration (FDA) Modernization Act in the US 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 for 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 visionary legislation will revolutionise access to clinical trial data, as it is free for all to access.
Source: HealthCanal.com