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Clinical trials

New medicines are evaluated thoroughly before they can be prescribed to treat patients - this evaluation often takes many years.

A medicine is a chemical compound that can treat or prevent a disease or condition. Compounds that have the potential to treat disease are first evaluated in the laboratory. This can include the use of computer models, cells and animal research. If the results are promising the medicine will then be evaluated in humans, in what are called "clinical trials".

Clinical trials are compulsory for all new medicines. Regulators will only give approval for a new medicine if these trials demonstrate it has a favourable benefit:risk profile.

Clinical trials are carefully planned to make sure that participants are protected and that the research yields valid results. A detailed plan for a clinical trial, known as a "protocol", is prepared by the company and reviewed and approved by an independent ethics committee before trials can go ahead.

All GSK-sponsored clinical trials are conducted according to the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH). These guidelines provide an internationally accepted ethical and scientific quality standard for designing, conducting, recording and reporting trials.

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