Clinical trials develop understanding of how a new compound works in humans. Whether working on a new medicine or a new vaccine, a research team will have typically examined many hundreds of compounds before arriving at a single candidate to be considered for testing in humans during clinical trials.

Clinical trials demonstrate whether or not the new treatment is able to deliver the intended therapeutic or disease prevention effect. They also clarify the most appropriate doses to administer.

The first trials cannot take place until an independent ethics committee has evaluated and approved the initial research work in the laboratory.

Though GSK is responsible for all clinical trials that we sponsor, they are organised in association with independent doctors and hospitals.

Details of the trials we are carrying out are available to everyone. Find out more about our current programme by visiting our clinical studies register.

Who takes part?

Everyone who takes part in a trial must have volunteered for it.

Trials are planned in a series of stages identified as Phases. Initially, in Phase I the compound being investigated will be given to a small group of volunteers to get a first indication of how the preparation interacts with the human system.  As a trial programme progresses, the efficacy of a potential medicine or vaccine will be monitored. This is done by giving the experimental medicine or vaccine to volunteers who already have the disease that is being targeted, or at risk of contracting it. The whole programme may take several years and involve many thousands of volunteers from different parts of the world before a new vaccine or treatment can receive formal approval for use. If, at any time, it becomes clear that patient safety may be compromised, the trial will be halted. 

If you are interested to know more about taking part in a trial visit our section on How you can volunteer.

How do we ensure safety?

No medicine or vaccine, even one that has been in use for some time, is without side-effects.  Introducing any externally generated chemical into the human system will have different effects on different people. 

The various phases of clinical trials help us understand the benefits of a new preparation against any risks of adverse effects.

This benefit-risk profile is monitored continuously as more and more patients are treated. With a rare side-effect, it may take many years to show, but these early clinical trials are the essential links between our development of a potentially promising compound in the research laboratory and regulatory approval for use by patients.

Our Global Safety Board (GSB) reviews the safety of GSK products once they are approved for prescription by doctors and all of the board's decisions are guided by the need to ensure that our medicines and vaccines have a positive benefit-risk profile.

Learn more about our commitment to patient safety by visiting our review of research practices.