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 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?
Whilst all our AstraZeneca sponsored clinical studies are conceptually designed and finally interpreted in-house, a percentage of them are run for us by external contract research organisations (CROs).
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 2011 percentage can be found in the annual data section.
Our clinical data handling is outsourced to Cognizant, a business process solution company and we have a strategic partnership with Quintiles Transnational to provide integrated services for the majority of our clinical pharmacology studies. These sourcing decisions have helped us to drive resource efficiency, promote consistency and, importantly, helped to speed up our internal data interpretation and decision-making.
All our suppliers are required to apply our standards and this is specified in their contract. Before they can become a provider of services to AstraZeneca, CROs must complete a thorough evaluation process. We review their facilities and staff and evaluate their processes and procedures to ensure compliance with regulatory and AstraZeneca standards. We have ‘Responsible Procurement’ processes which assess a range of risks including a CRO’s commercial stability, reputation, management systems, business principles and R&D ethics. We also assess compliance with regulatory guidelines and Good Clinical Practice, whether the CRO has proven experience and capability, and any specific risk factors related to the region or country in which it operates. These factors are assessed through Request for Information documents, facility inspections and capability reviews. We regularly monitor and audit ongoing work at suppliers involved in our clinical trials.