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Public disclosure of trial results

The pharmaceutical industry is 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 after approval. Safety and efficacy information is provided to doctors through prescribing information which is approved by regulators.

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

GSK has taken a significant step this year to respond to concerns about access to trial results.

Our approach
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 clinical 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.

In 2004 there were 374 such publications describing the results of GSK’s clinical trials. The number of publications each year depends on the number of trials completed and the number accepted for publication.

 

Number of publications of GSK clinical trials
Y2001	Y2002	Y2003	Y2004
549	364	437	374

GSK cannot guarantee publication of trial results by these methods since this is at the discretion of journal editors and conference organisers. That is why we launched our online Clinical Trial Register in 2004, to supplement prescribing information and publications in the scientific literature (see Clinical Trial Register).

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.

By the end of 2004 results for 143 clinical trials had been published on the site. We aim to post, by the end of 2005, the trial results from all clinical trials of marketed products completed since the merger of GSK as well as earlier trials of these products if they are likely to inform medical judgement. Trial results for new products approved for marketing will be posted on the register by the time that medicine is first launched in a major market.

To maximise access to our clinical trial data, we have also committed to posting trial results on the PhRMA clinical trials results database (www.clinicalstudyresults.org).

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 (www.ClinicalTrials.gov) when the trials initiate enrolment. This provides information about the trial's purpose and contact details for further information, enabling patients and investigators to take part. In addition to posting summary protocols for serious or life-threatening diseases, in 2004 we made an additional commitment to post summary protocol information for all other GSK-sponsored clinical trials on the site. This will facilitate participation and enable interested parties to track the trials taking place and the subsequent public disclosure of their results.

We are dedicated to assuring that our results Register and our posting of summary protocol information of trials initiating enrolment are consistent with our stated commitments. To that end, we are establishing a means of providing third-party compliance verification that information being posted to the public databases is in agreement with the principles that we have established. This will be conducted with the assistance of an external organisation - we expect to complete the first full compliance verification exercise in Q3 2005.

Additionally, GSK will assemble an international advisory board to provide input on matters related to the public disclosure of information arising from our clinical research activities.

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