Clinical trials are the recognised way in which pharmaceutical companies, medical institutions, academic research organisations and others study potential new medicines to understand the benefits and risks and to fulfil all legal requirements for approval of new drugs.
We take very seriously our responsibility to deliver consistently high standards of ethical practice and scientific conduct in all our trials, wherever they take place.
At any one time, AstraZeneca may have hundreds of clinical trials underway in different locations around 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.
A potential new medicine is tested in humans only after rigorous and extensive pre-clinical research has confirmed its potential efficacy and safety. All medicines have side effects that may affect some people and so the safety of any medicine needs to be assessed in terms of its benefit/risk profile. We can’t eliminate completely the risks to clinical trial participants but we aim to minimise these as much as possible. Our standards require that stringent safeguards are put in place for all our trials to protect participants and avoid serious adverse reactions. We take any deviations or breaches very seriously and investigate incidents rigorously, taking action to correct them and prevent re-occurrence.
We also have strict procedures for making sure that patients fully understand possible benefits and risks before taking part in a trial. Their informed consent to taking part must be obtained before a trial begins and participants are free to withdraw from a trial at any time without explanation.
Our standards are global and apply to all AstraZeneca clinical trials, in all locations, whether they are being conducted by us or on our behalf by external contract research organisations.
We recognise that there is currently some public concern about the conduct of clinical trials, in particular the perceptions that:
- 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.
- Unfavourable trials results are not made public.
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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