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Conduct of clinical trials

The safety and effectiveness of new medicines must be evaluated in clinical trials before they can be approved for marketing.

Regulators will only give approval if trials demonstrate that a product is safe and effective and that its benefits outweigh any risks from potential side effects.

A new product will typically be tested through three stages of clinical trials. These involve both healthy individuals and patients with the relevant disease. In 2004 there were 140 projects in clinical development.

Traditionally most clinical trials have been carried out in Western Europe and the US. It is however becoming increasingly challenging to enrol sufficient patients in these countries as the increasing number and scale of trials is often utilising most of the available investigators and patients. Therefore as clinical trial capabilities in Eastern Europe, Latin America and Asia have improved significantly in recent years, we are starting to conduct more trials in these regions. We also conduct a number of clinical trials in the least developed countries of the world to evaluate medicines for diseases that disproportionately affect these countries.

During any clinical trial the safety of participants and future patients is our first priority. All our trials, wherever they are conducted, are carried out according to international standards of good clinical practice and applicable laws and regulations. The trial protocols are reviewed by external regulatory agencies in the relevant countries when required and all protocols are considered by relevant ethical review committees whose remits cover the sites where studies will take place. Safety data are routinely collected throughout development programmes and are reported to regulators in line with applicable regulations as well as being reviewed by GSK on an ongoing basis for any safety signals. The GSK Global Safety Board is responsible both for approval of pivotal protocols and internal assessment of any issues related to patient safety that arise during the development programme.

Good Clinical Practice standards
All 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. They cover issues such as the selection and training of trial investigators, gaining informed consent from trial participants, monitoring and quality assurance.

All trials must be approved by an independent ethics committee to ensure the trial is justified and that it is designed and will be conducted according to appropriate ethical standards. These committees have the power to reject or stop a clinical trial. An ethics committee is typically composed of lay people, medical professionals and scientists.

We conduct audit activities to ensure clinical trials are conducted to the appropriate standards, see training and auditing for clinical trials.

Clinical trials in Eastern Europe, Latin America and Asia
The pharmaceutical industry is starting to perform more trials in regions such as Eastern Europe, Latin America and parts of Asia.

There are several reasons for this. Clinical trial capabilities in these regions have improved significantly in recent years and trials in these countries can help to speed up the research process and ensure new medicines get to patients more quickly. Fewer patients are enrolled into trials in these countries so it is easier and quicker to find patients to participate. These patients have often used fewer medicines compared with those in Western Europe and the US. This makes them good candidates for a clinical trial because it is easier to assess the effect of the products being tested. Cost is also a factor, with operating costs in these countries being lower. Our objective is to carry out more of our clinical trials in Eastern Europe, Latin America and parts of Asia by 2005.

There are concerns that trials in these regions may not be carried out to the same high standards as those in Western Europe and the US. All GSK clinical trials are carried out to the same standards of GCP everywhere in the world. This is vital to protect patients and ensure that we can gain regulatory approval for new medicines.

Clinical trials in diseases of the developing world
GSK has seven products in clinical development for diseases that disproportionately affect the developing world. For more on R&D for developing world diseases see access to medicines.

Clinical trials for diseases of the developing world need to be carried out in countries where the disease is prevalent, and these can include some of the world’s least-developed countries. All trials that we sponsor, irrespective of location, are conducted according to the standards applied in developed countries.

In some of the least-developed countries extra efforts may be required to ensure that we meet global standards. For example, in areas with low literacy levels it can be difficult to obtain informed consent from trial participants. In these cases investigators work with independent witnesses to make sure that the trial is properly explained to participants and that they understand what is involved.

For more information on our policy and procedures in this area see clinical trials in the developing world.

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