Clinical trials – what are they and how do we protect the people taking part?
Monday, 15 March 2010
Clinical trials are the means by which we study the effects of a potential new medicine in humans – after we have confirmed its potential efficacy and safety in pre-clinical research.
The path to a new medicine can take more than 10 years and there are many different 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 which centres on safety and how well the medicine works.
A potential new medicine is submitted for testing in humans only after it has successfully travelled the path of extensive and rigorous pre-clinical research, which includes in vitro testing (laboratory techniques) and animal studies.
Clinical trials represent a significant undertaking, including collaboration with clinicians in many countries and involving thousands of people. Two types of people participate in clinical trials – healthy volunteers and patients. All potential participants are fully informed about all aspects of the trial and their individual consent is gained before they start. All take part on a voluntary basis.
All trial proposals are first subject to stringent internal review and before a trial can begin, it must be approved by the appropriate external independent ethics committee or institutional review board.
Data from our pre-clinical and clinical research studies are required by our regulators to support any submission to them for approval to market a new medicine.
We take very seriously our responsibility to protect the people taking part in our studies from any unnecessary risks.
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 completely eliminate risks to the volunteers who take part in our clinical trials, we seek to make sure that we minimise the potential risks. Throughout the research process, we continuously review, and make judgements on whether the potential benefits of a new medicine continue to outweigh the risk of side effects.
In addition to compliance with all relevant laws, we have strict internal procedures for managing safety issues during clinical trials and making sure that we act in the best interests of participants. Our global standards require that stringent safeguards are put in place for all our trials to protect participants and avoid serious adverse reactions.
We conduct an increasing number of our clinical trials at multiple sites in several different countries.
A broad geographic span helps us to make sure that those taking part in our studies reflect the diversity of patients around the world for whom the new medicine is intended. This approach also helps to identify the types of people for whom the treatment may be most beneficial.
We do not conduct trials in the Lowest Human Development countries as ranked in the United Nations Development Programme and have no plans to do so in the future.
We have global standards that apply to all our clinical trials, wherever they are taking place.
At any one time, AstraZeneca may have hundreds of clinical trials underway in different locations around the world. 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.
Our key principles for conducting clinical trials are outlined in our Global Bioethics policy. Compliance with relevant laws and regulations governing research and development is a minimum baseline and underpins AstraZeneca’s own standards.
We will always work to the highest of the standards required by the external international, regional or local regulations, or our own internal standards.