Corporate Responsibility Report 2008

Performance

We have continued to improve our patient safety systems, safety databases and monitoring processes. Examples from 2008 include:

Established two more Clinical Toxicities Strategy Panels (comprising internal and external experts) to provide expert safety input throughout the medicine development process. We now have expert panels in four areas: cardiovascular, hepatic, renal and haematological
Implemented a clinical trials signal detection (CTSD) tool for review of completed study data, in partnership with Lincoln Technologies. This has enhanced our ability to identify and explore safety signals in our clinical trials. The system won a BIO IT award
Launched a prototype for our Molecular Clinical Safety Programme (MCSP). MCSP is a tool that seeks to better inform decision-making in medicine development by integrating chemistry, pre-clinical and human safety data and enabling us to look for patterns across the different types of safety information. In October 2008 the GSK team won the Wall Street Journal Technology Innovation Award for Healthcare IT for developing this system. The entry was selected by an independent panel of judges, who reviewed more than 700 applications for the awards

Working with others

We work with government officials, industry partners and policy makers in efforts to build an enhanced safety system. For example GSK is the industry lead in the benefit-risk project consortium of the European Commission’s public-private partnership, the Innovative Medicines Initiative, which aims to develop methodologies to enhance the assessment of the benefit-risk profile of new medicines.

GSK is a key partner among the US Food and Drug Administration, other pharmaceutical companies and academia in the US to explore the development of a new system for the detection of adverse events and benefits of medicines using large healthcare system databases.

Read about our collaborative research on emerging technologies.

Serious Adverse Events Consortium

In 2007, we co-founded the Serious Adverse Events Consortium (SAEC), a collaboration involving more than 20 partners. The SAEC is working to improve patient safety by identifying genetic variants that predict adverse events such as drug-induced liver injury and a rare but serious severe skin rash called Stevens Johnson Syndrome. GSK scientists co-chair the SAEC scientific management committee and have a seat on the board of directors.