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Single trial data point

The international pharma industry is launching a central internet search portal in a bid to ease concerns over how clinical trials data are made available to the public.

The international pharma industry is launching a central internet search portal in a bid to ease concerns over how clinical trials data are made available to the public.

The portal, which is the brainchild of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), aims to provide a one-stop-shop gateway for patients and doctors on information about ongoing and completed clinical trials. It will establish links to pharma company-owned websites and other commercial or government-sponsored sites which contain drug information provided by the industry.

Last January, drug companies in the US, Europe and Japan agreed on a voluntary code designed to make the clinical trials process more transparent.

The move came after sustained media criticism of the industry, culminating in eleven editors of major medical journals (including the New England Journal of Medicine, the Journal of the American Medical Association and the Lancet) agreeing not to publish any studies not listed in a national registry when they began.

Daniel Vasella, IFPMA president and also chief executive of Novartis, said the site would provide an important benefit to the doctors, patients and families when evaluating the latest biomedical research information and details on clinical trials.

ìThe internet portal will ensure that we help those in need and the medical community to rapidly and easily find the data that can facilitate medical decisions about therapies and future potential treatments,î he noted.

While individual companies declined to comment on the initiative, it is thought most chief executives are keen to get behind the scheme, which could help to improve the industry's tarnished image.

The website stops a long way short of full disclosure: early stage phase I trials are exempt and companies are under no obligation to reveal results of studies before drugs receive regulatory approval. Last year, the US pharma industry association decided against a mandatory registry of phase I trials, saying it might prove commercially damaging.

Some pharma firms, such as GlaxoSmithKline and Eli Lilly, have already set up their own publicly available registries and two years ago, the Association of the British Pharmaceutical Industry (ABPI) launched a voluntary clinical trials database for members. However, up till now only seven companies have entered information.

IFPMA said the website, which is being developed by IBM, would be launched in September this year.

30th September 2008

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