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 Bioethics Policy and include:
- AstraZeneca will safeguard the interests of all participants in our clinical trials.
- AstraZeneca’s informed consent process must give subjects, parents and legal guardians sufficient information about the benefits and risks, prior to enrolment.
- All research proposals must be reviewed by ethics committees, and regulatory authorities (where required) in the countries where the study will take place.
- Compensation for research participants must be consistent with the principle of voluntary participation in clinical studies.
- Payments to clinical study organisations and investigators must be based on the work they perform and costs incurred.
- All data must be recorded, handled and stored in a way that protects participants’ privacy, and enables accurate and transparent reporting, interpretation and verification.
Compliance with relevant laws and regulations governing research and development is a minimum baseline and underpins AstraZeneca’s own standards. This includes compliance with international standards of good practice, such as Good Clinical Practice, Good Manufacturing Practice and Good Laboratory Practice.
We work to the highest of the standards required by the external international, regional or local regulations, or our own internal standards.
How do you protect the impartiality of doctors involved in your trials?
Doctors and other healthcare professionals play a key role in our clinical trials. We rely on their expertise to provide high quality, objective research. Many studies are double-blind so that neither the patients nor the doctor will know which participants are receiving the compound being tested and which are receiving alternative treatment or placebo. Payments to clinical study organisations and investigators must be based on the work they perform and costs incurred. Appropriate levels of payment are determined on a local basis.
How do you make sure your policies are implemented in practice?
Our standards apply to all AstraZeneca sponsored clinical trials, in all locations. Compliance with our standards is monitored regularly in all our studies, overseeing the progress of the trial and ensuring that the trial is conducted, recorded and reported according to the standards. We have robust systems in place to monitor regularly the conduct of our clinical trials to ensure they meet international and our own high standards. This includes regular monitoring visits by AstraZeneca or the CRO working on our behalf to confirm conduct of the study according to the protocol, and review of the informed consent process and documentation. In addition, our independent compliance organisation conduct a wide range of audits of our clinical research-related activities, whether they are being done in-house or by third parties. This includes audits at investigator trial sites as well as audits of systems and processes and external providers. There may also be inspections by regulatory authorities, which are usually linked to sites involved in trials where data submissions for regulatory approval have been made.
Any identified deviations or breaches are taken very seriously and investigated thoroughly, and action taken as appropriate to correct them and prevent reoccurrence. Examples of action we might take include training of internal staff or investigators and changes in procedures or documents to clarify processes. If necessary, we would discontinue the use of sites or investigators in further trials. Ethics Committees and regulatory authorities are informed, as appropriate.
The conduct of our trials in emerging countries is a specific focus for our compliance monitoring and assurance activities, in line with our high level commitment to working to global standards that apply wherever a trial takes place. Our monitoring and auditing are key to ensure our trial sites are adhering at all times to these rigorous standards.
Do you use contractors and how do you make sure they apply your standards?
It is common practice in the pharmaceutical world for companies to work with third party organisations – particularly to add resource when needed and where they have a strong clinical geographic presence. These organisations work to very rigorous regulatory and AstraZeneca standards. Before they become a provider of services to AstraZeneca, Clinical Research Organisations have to successfully complete a thorough evaluation process that includes reviews of their facilities and staff and an evaluation of their clinical practice to ensure that it is GCP (Good Clinical Practice) Compliant. They must also have a proven record of meeting regulatory requirements. Studies carried out on behalf of AZ are overseen by an AZ medical director within that geography and the work monitored to ensure adherence to good clinical practice and regulatory and AZ standards.
The percentage of studies we place with CROs varies, depending on the number of trials we have underway and the amount of internal resource available to do the work. The 2013 percentage can be found in the annual data section.