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Corporate Responsibility Report 2008

Clinical research

We carry out a series of clinical trials to evaluate investigational medicines for their potential to become new medicines. The effect of the potential medicine will often be compared against marketed medicines or in some cases an inactive substance (a placebo). Successful clinical trial programmes usually have three or four phases, and safety is evaluated throughout the clinical trials process.

We have rigorous procedures and assurance processes to ensure our clinical trials of our medicines are conducted according to the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH) and the principles contained in the World Medical Association Declaration of Helsinki on the ‘Ethical Principles for Medical Research Involving Human Subjects (2008)’. GSK-sponsored clinical trials are conducted to the same ethical standards irrespective of whether they take place in developed or developing countries.

The safety of those who participate in our clinical trials is of paramount importance. Our informed consent procedure ensures that all volunteers are informed of aspects of the trial that are relevant to their decision to participate.

All GSK employees involved in conducting trials receive training on regulatory requirements and GSK policies and trials are subject to audit by our internal audit department and regulators.