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Research and innovation

New medicines and vaccines have brought huge benefits to the health and quality of life of millions of people over the last 100 years. But continued R&D remains as important as ever. There are still many serious, debilitating and life threatening illnesses for which there are no effective treatments or where treatments could be significantly improved.

The most important element of corporate responsibility for us is the contribution our products make to health. Our goal is to build the best research pipeline in our industry by developing new medicines and vaccines for unmet medical needs.

We have 158 prescription medicines and vaccines in clinical development – including many for diseases disproportionately affecting developing countries.

We know that biomedical and pharmaceutical research can raise ethical concerns, from the use of new technologies to the objective reporting of clinical trial results. The nature of our business makes it critically important that we meet high ethical and scientific standards in our work.

Here we explore how we make results of our clinical trials available, our approach to authorship of journal articles and our investment in research to improve patient safety. More details are provided in our full CR report.

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

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.

In addition there is a need to use other ways to appropriately communicate the results of our clinical trials. 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. At the end of 2006 we had published results from 2,760 trials.

We also post protocol summaries of all clinical trials, irrespective of the countries involved, to the US National Institutes of Health website.

Our approach to authorship of journal articles
There have been concerns about ghost writing of journal articles, where doctors put their names to articles written by pharmaceutical companies. GSK’s policy is that:

• Authorship and acknowledgements for articles must be consistent with journal guidelines and be determined 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, lead the content development, and retain 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.

Patient safety
Monitoring, investigating and evaluating patient safety is critical, both during development of new compounds and after a new medicine or vaccine has been approved for use.

As well as implementing robust systems for monitoring and reporting side-effects from GSK medicines, we are investing in a number of areas of emerging science that have the potential to enhance patient safety. Pharmacogenetic research is one example.

Pharmacogenetics is the study of genetic variations that predispose individuals to respond differently to medicines. It is a research area with the potential to improve the effectiveness of medicines and patient safety, by identifying which patients are more likely to benefit from a medicine and which may be susceptible to side-effects

Pharmacogenetics relies on analysing the DNA of participants in clinical trials. We collect blood samples for potential DNA analysis in the majority of our Phase I, II and III drug development trials. Pharmacogenetic research always requires ethics committee reviews and approval, as well as informed patient consent.

Number of summaries of GSK clinical trials on the GSK Clinical Trial Register (cumulative total)