Wednesday 16 July 2008

New source for research results

The passing of a law in the US is going to have a massive impact on the way that clinical trial results are disseminated.

The Food and Drug Administration (FDA) Amendments Act 2007 mandates the public disclosure of trial results on the clinicaltrials.gov website within a year of completion.

The law will have far reaching consequences as it applies to all trials 'if the products concerned need approval by the FDA.' That means it doesn't matter who sponsors the trial, or where it's conducted : if the product is on the radar of the FDA, which reglates medicines in the USA, the responsible parties risk a fine of $10,000 for non-compliance.

The law comes into effect in September 2008.

For more on the FDA Amendments Act, see:
Editorial in the BMJ Use your NHS Athens
Editorial in PLoS Medicine

For more on trial resgistration, see
Ottawa statement on trial registration

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