The global pharmaceutical industry has pledged to set up a worldwide clinical trials register in a bid to reassure patients about drug safety in the wake of the furore that has arisen over the issue.
Under proposals drawn up by the world’s major pharmaceutical industry trade associations from Europe, Japan and the USA, the results of all Industry-sponsored clinical trials, regardless of outcome, will be included on the database. Companies will have 21 days from the start of a trial to complete its registration, and results should generally be posted within one year from the product winning approval. Studies beginning on or after July 1 this year will be included in the registry, while ongoing trials that meet the requirements will be added by September 13. The database will also include links to the results of trials that have been published in peer-reviewed journals. Exploratory trials will not be included on the registry.
The move has been heralded by UK Industry body, the Association of the British Pharmaceutical Industry. Director general, Dr Richard Barker, said: “By publishing not just the results of trials that have taken place – whether positive or negative – but also those that are just starting, the industry has made a major step towards achieving greater transparency. It is now up to the other sponsors of clinical trials to commit themselves to follow suit.”
The issue of whether companies actually do disclose all trial data came to a head last summer when New York attorney general, Eliot Spitzer, sued GlaxoSmithKline claiming the firm had withheld negative trial information on the safety and efficacy of its Paxil (paroxetine) antidepressant in children and adolescents [[03/06/04a]]. The UK drug giant has since agreed to pay $2.5 million to settle the claims, and to set a precedent in establishing its own clinical trial registry. Other firms, including Eli Lilly, have since followed suit, and the International Committee of Medical Journal Editors, which represents such prestigious publications as The Lancet, the Journal of the American Medical Association and the New England Journal of Medicine, took the bold move last year, saying they would not publish trial results unless the data are included in a public registry [[10/09/04b]].
Concerns about drug safety have also simmered for years, but arose again late last year when Merck & Co decided to withdraw its top-selling painkiller, Vioxx (rofecoxib), after it was linked to an increased risk of heart attack and stroke [[01/10/04a]]. The firm has since come under fire for not acting sooner – concerns over possible cardiovascular side effects associated with the product’s use first came to light several years ago, but were dismissed at the time [[26/09/01a]], [[09/02/01a]]. The Vioxx withdrawal brought the issue of drug safety back to the fore, as did comments by US Food and Drug Administration scientist, David Graham, that five marketed medicines could pose a risk to human health [[19/11/04a]], [[22/11/04a]]. Regulators on both sides of the Atlantic have since launched investigations into the influence of the pharmaceutical industry [[12/11/04a]], [[21/06/04b]].