Clinical trials

A clinical trial only takes place once we have gathered satisfactory safety and efficacy information from pre-clinical research and the regulatory authorities have given us approval to run the trial.

We take very seriously our responsibility towards the people taking part in our clinical trials and we have global standards that apply to all our trials wherever they take place.

The safety and privacy of participants is a top priority, as is ensuring that they fully understand the nature and the purpose of the trial before they give their consent.

We make clinical trial registration and results information concerning new and ongoing trials available on public websites – irrespective of whether the results are favourable or unfavourable to AstraZeneca.

We take very seriously our responsibility to deliver the highest standards of ethical practice when conducting clinical trials anywhere in the world. Our top priority is to make sure that that those taking part in our studies are not exposed to any unnecessary risks and that, before they give their consent, they understand fully what taking part in a trial means.

It takes between 10 and 15 years to develop a new medicine. There are many stages of research. We investigate thousands of compounds at the start of the process but only a few complete the journey to become a new medicine because of the demanding criteria of the ongoing selection process. Research can be discontinued at any time if we find that a compound isn’t proving to be sufficiently effective in treating the target disease or it has unacceptable side-effects.

A candidate medicine is submitted for testing in humans (clinical trials) only after we have confirmed its potential efficacy and safety in extensive and rigorous pre-clinical research, which includes in vitro testing (laboratory techniques) and animal studies.

All medicines have side effects that may affect some people and the safety of any medicine needs to be assessed in terms of its benefit/risk profile. While it is not possible to entirely eliminate risks to volunteers who take part in our clinical trials, we seek to make sure that we minimise the potential risks. Our global standards require that stringent safeguards are put in place for all our trials to protect participants and avoid serious adverse reactions.

Read more on protecting participants.

We recognise that there is currently some public concern about the conduct of clinical trials, in particular the perceptions that:

• Commercial interests may be allowed to influence research findings and pharmaceutical companies may have an incentive to conceal negative results or exaggerate the benefits of their products
• Trials may be held in less developed countries to reduce costs and that this may affect the quality of research or expose participants to medicines not intended for use in those communities
• Participants may not fully understand the risks involved or realise they are taking part in a trial, due to a lack of education or language and literacy difficulties.

This section explains how we run trials in AstraZeneca to protect the people who take part and maintain the integrity of our research results. We describe the standards we have in place to ensure that our commitment is applied consistently wherever a trial is conducted. You can also read about how we make information publicly available about our new and ongoing clinical trials, whether or not results are favourable to AstraZeneca.

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At 21-Nov-2009 06:25  GMT