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Clinical trial information and results

We make the results of our clinical trials widely available to healthcare practitioners and others who use or evaluate the use of our medicines. We also publicly disclose information on ongoing trials.

Ongoing clinical trials
Publicly available internet-basedregistration of ongoing clinical trials can provide a stimulus for increased participation in clinical research. It also provides an important reference point so interested parties can track the subsequent disclosure of clinical trial results.

GSK is legally required to post summary protocol information for ongoing studies of treatments for serious or life-threatening diseases conducted under a US Investigational New Drug Application on the National Institutes of Health website. During 2005, we made an additional commitment to post protocol summaries of all patient clinical trials, irrespective of the countries involved, initiated on or after 1 November 2004 or ongoing as of 1 July 2005 to clinicaltrials.gov. At the end of 2005 there were 159 protocol summaries of actively recruiting clinical trials on the
NIH website.

Our postings meet the requirements of the International Committee of Medical Journal editors. For non-phase III trials, our policy is to delay registration of certain data elements on an exceptional basis when they are competitively sensitive.

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Clinical trial results
Pharmaceutical companies are legally required to disclose all relevant data from clinical trials to the appropriate regulatory authorities when seeking approval for a new product.

After approval, sponsors have a continuing obligation to provide regulatory authorities with updated safety information from clinical trials. This ensures regulators can accurately assess the safety and effectiveness of new medicines and monitor their safety. Safety and efficacy information is provided to doctors through prescribing information which is approved by regulators.

In addition there is a need to use other ways to appropriately communicate the results of our clinical trials to healthcare practitioners and others who use or evaluate the use of our medicines.

GSK follows the PhRMA Principles on the Conduct of Clinical Trials and the Communication of Clinical Trial Results and is committed to timely communication of results for all products approved for marketing.

Wherever possible we publish our trial results in peer-reviewed scientific and medical journals, or in conference abstracts and proceedings. These are used by research and healthcare communities to obtain the latest information on treatments.

GSK cannot guarantee publication by these methods since this is at the discretion of journal editors and conference organisers. For this reason, we launched the GSK online Clinical Trial Register in 2004, to supplement prescribing information and publications in the scientific literature. The register contains results and protocol information from GSK-sponsored trials of marketed medicines. It also provides references to publications that have appeared in medical journals. Anyone can use the internet to access the register.

There have been concerns about ghost writing of journal articles, where doctors put their names to articles written by pharmaceutical companies. GSK’s approach is that authorship and acknowledgements for articles must be consistent with journal guidelines and must be determined based on the level of contribution to study design, data acquisition, analysis and interpretation, and writing or revising the manuscript. The named senior author for a paper must actively participate in the drafting process and lead the content development of manuscripts. The senior author works closely with co-authors and retains final approval authority for the manuscript. Any GSK staff or contractors who contribute to the development of manuscripts for external authors must be named in the article.

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Activity in 2005
At the end of 2005 there were 2,125 clinical trial summaries on the GSK Clinical Trial Register. This includes over 98% of the clinical trials of our major marketed products which have been completed since the merger of GSK or were completed before the merger and are likely to inform medical judgement. We are continuing to populate the register with clinical trials that relate to other marketed medicines and this will be completed during 2006.

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Our objective is to publish trial results for all new products within 10 months of the product reaching the market and to publish the results of trials completed after a product is approved for marketing within one year of trial completion.

An independent assessment of documentation processes and procedures used by GSK in populating the Clinical Trial Register has been conducted by an external organisation. We will continue to engage the services of this organisation to ensure that GSK complies with the corporate policies and procedures that it has established to fulfill our commitment to make information from our clinical research activities available to the public. In addition we are actively involved in sharing our views and experiences on clinical trial registration through an advisory board process established by the World Health Organization which is establishing an International Clinical Trials Registry Platform.

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