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Progress On Clinical Results Transparency

Friday, February 2, 2007

Since the International Committee of Medical Journal Editors (ICMJE) announced in September 2004 that it would consider for publication an article about a research project only if it was posted to a central registry before September 13, 2005, pharmaceutical companies have committed significant personnel, time and money to the issue of clinical trials transparency. And their efforts are paying off.

According to an editorial published recently in the New England Journal of Medicine, only 8% of clinical trials listed in the first 11 months of 2006 on clinicaltrials.gov, the National Institutes of Health’s registration web site, had incomplete information, compared to 26% of trials listed before 2006.

Thomson CenterWatch estimates that industry spending on trial registries will continue to rise. In 2005, the top 15 biopharmaceutical companies spent $89 million for various efforts to disclose clinical trial information, and CenterWatch estimates that they will spend $97 million this year…

At a time when big pharma is under pressure to keep down headcount, major biopharmaceutical companies have dedicated anywhere from 25 to 40 full-time equivalents (FTEs), depending on the retrospective work required, to clinical transparency efforts.

As biopharmaceutical companies move forward with providing clinical trials information to the public, through registries and results databases, the industry faces a multitude of challenges: how to collect information internally and how to get it into the right format for posting; meeting staffing requirements for processing, posting and maintaining this information; guarding against competitors using detailed clinical trial information to make adjustments to their own strategies; and deciding which results, positive or negative, are statistically significant enough to report.

As the issues of transparency and increasing pubic trust in the conduct of clinical research have grown in importance, so has the number of web sites disclosing clinical trials and clinical trial results. Another critical challenge involves explaining to the public what all the clinical trial information available on web sites truly means.

In addition, for true transparency, the industry needs more commitment not only from small to medium-sized biopharmaceutical companies, which often lack internal resources needed for these types of initiatives, but also from academic sites doing clinical research.

The recent statistics from NEJM paint a promising picture, but the ultimate goal is for the industry to be truly transparent.

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