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Conduct of clinical trials

The safety and effectiveness of new medicines must be evaluated in human 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 2005 there were 149 projects in clinical development.

All clinical trials, wherever they are carried out, 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’ (2004). The ICH 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.

We have policies to ensure that medical practitioners running GSK-sponsored clinical trials are selected and recompensed appropriately. Our policy on Payments to Healthcare Practitioners and Institutions Conducting GSK-Sponsored or GSK-Supported Clinical Studies states that clinical trial investigators must be selected solely on their qualifications to conduct clinical research. Their history of using GSK products must not be taken into account. Payments to practitioners reflect fair market value for the work performed and no payments are offered or made that could influence their judgement on whether to enrol or maintain a participant in a clinical study

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Standards for clinical trials
Trial protocols (the plan for how a clinical trial will be conducted) 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.

An ethics review committee is composed of lay people, medical professionals and scientists. They assess whether a trial is justified and whether it is designed and will be conducted according to appropriate ethical standards. Ethics committees have the power to reject or stop a clinical trial.

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. We audit clinical trials to ensure they are conducted to the appropriate standards, see Training and Auditing for Clinical Trials.

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Clinical trials outside Western Europe and North America
GSK conducts clinical trials to answer scientific questions and to meet regulatory requirements. We seek to conduct clinical trials where:

• The population is relevant to the scientific question and where the results can be generalised to broader populations.
• High quality data can be obtained.
• Costs can be minimised.

Most clinical trials take place in Western Europe and North America. Trials in developing countries are also conducted to evaluate new medicines for many different diseases. These include diseases that were previously considered as only prevalent in the developed world, but which are now common in developing countries. We are therefore looking to increase the number of patients we recruit into trials in Central and Eastern Europe, Asia, South America and South Africa. In addition, GSK has an ongoing commitment to invest in research and development that targets diseases which disproportionately affect developing countries (e.g., malaria). Clinical trials in developing countries are usually required to develop these investigational compounds. It is important to note that clinical trials of investigational medicines are not conducted in countries when it is known at the outset that there is no intent to pursue registration and make the medicine available for use in that country.

Development of medicines
GSK is starting to perform more trials in regions such as Central and Eastern Europe, South Africa, Latin America and parts of Asia. There are several reasons for this:

• Healthcare infrastructure and clinical trial capabilities in these regions have improved significantly in recent years. For example, many physicians, now working in developing countries, have been trained and educated to global standards. Therefore, clinical trials can now be more readily conducted and effectively monitored in these countries.
• Changes in living standards mean diseases previously common only in the developed world (e.g., hypertension and diabetes) are now becoming prevalent in developing countries. Including patients from many ethnic backgrounds enables us to develop medicines in a truly global fashion and helps us to evaluate whether new treatments are suitable for different ethnic groups.
• As the number and scale of trials taking place in North America and Western Europe increases it is more difficult to find experienced investigators who are able to start trials and recruit suitable patients quickly. Fewer patients are enrolled into trials in other countries so it is easier to find participants. This speeds up the research process and helps ensure new medicines get to patients more quickly.
• Patients in these countries have often used fewer medicines than those in North America and Western Europe. This makes them good candidates for a clinical trial because it is easier to assess the effect of the medicine being tested.
• Regulators around the world now require significant amounts of clinical data to approve a medicine. This impacts both the pool of available patients in North America and Western Europe and increases the costs associated with conducting clinical trials in these countries. Recruitment costs per patient in countries outside North America and Western Europe are lower, thereby allowing pharmaceutical companies to meet regulatory requirements and financial demands.

Relevant populations
GSK is committed to investing in R&D for diseases disproportionately affecting developing countries, see Access to Medicines. These compounds must usually be tested through clinical trials in developing countries where the disease is prevalent and the medicine is relevant for the local population. For example, the incidence of malaria in the developed world is very low. This means we can only conduct scientifically robust clinical trials for new malaria treatments in developing countries.

There are concerns that trials in these regions may not be carried out to the same high standards as those in Western Europe and North America. GSK-sponsored clinical trials are conducted to the same ethical standards irrespective of the location. All studies meet international and national regulatory and legislative requirements and are conducted in accordance with principles of Good Clinical Practice (GCP) and the principles contained in the World Medical Association Declaration of Helsinki on the ‘Ethical Principles for Medical Research Involving Human Subjects’ (2004).

In some of the least-developed countries additional measures are often needed. For example, in cultures other than those in Western society, while still complying with ethical and legal requirements, additional steps are taken to match the objectives of informed consent to local culture. For example local leaders and/or family members may need to be involved.

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Post-trial treatment
We are sometimes asked what happens to a patient’s treatment at the end of a trial.

It is important to realise that GSK is not, in general, responsible for the provision of nationally licensed medicines (treatments already approved for use) after a trial. For this reason, GSK-sponsored clinical trials in chronic conditions will not be carried out unless we are assured at the outset that the national healthcare system is able to provide, and is responsible for, the continued care of trial participants, after the trial. Importantly where patients are initiated on nationally licensed medicines during a trial in a chronic disease, we need to be assured that, where there are no suitable alternatives, these medicines will be made available after the trial to those patients who derived a measurable medical benefit.

GSK also recognises that there may be circumstances when there is a compelling medical rationale for patients who have derived a measurable medical benefit from an investigational compound (a medicine that has not yet been approved) during a clinical trial to continue to receive that compound. For example, if the illness being treated is life threatening or seriously debilitating and there are no other treatments available or there are significant risks in switching patients to alternative treatments. When this is the case, post-trial treatment with the investigational compound is provided with appropriate oversight, for example in a clinical trial setting. GSK commits to provide the investigational compound for as long as necessary or until the compound is approved and licensed in that country.

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