ABPI moves to increase data transparency

by | 4th Jul 2005 | News

The Association of the British Pharmaceutical Industry has made its own contribution to the effort to promote openness in the conduct of clinical trials, with the publication of links to several clinical trial databases on its website.

The Association of the British Pharmaceutical Industry has made its own contribution to the effort to promote openness in the conduct of clinical trials, with the publication of links to several clinical trial databases on its website.

The Industry has come under considerable criticism of late for what is perceived as a lack of transparency in clinical trial disclosure, which in turn has led to accusations that companies have selectively published positive trial results whilst hiding negative ones. The ABPI said its move “clearly demonstrates our very real desire to make this information readily available to those who want it.”

The issue of clinical trial disclosure came to the fore last summer, when New York Attorney General, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline, alleging that the UK drugmaker had suppressed negative results showing its antidepressant Paxil (paroxetine) was linked to an increased risk of suicidal thoughts and acts in children and adolescents [[03/06/04a]].

The Industry responded to this controversy by committing to a worldwide clinical trials register [[07/01/05a]]. Meanwhile, some individual pharmaceutical companies have unilaterally established their own databases, including GSK [[02/09/04c]], Merck & Co [[06/09/04e]], Forest Laboratories [[10/02/05d]], Eli Lilly [[04/08/04b]], and Roche [[24/01/05a]].

In a statement, the ABPI said that its hyperlinks go through to databases covering more than 4,000 clinical trials, of which 1,349 are still recruiting patients.

The moves have also been spurred on by the actions of the International Committee of Medical Journal Editors, representing top medical journals such as The Lancet, Journal of the American Medical Association and New England Journal of Medicine, which set a July 1 deadline for the setting up of a public database [[24/05/05c]]. Last September, the ICMJE said it would stop publishing trial results unless the data were included on a public database [[10/09/04b]].

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