Our commitment to clinical trial transparency
As a science-led biopharmaceutical company, our clinical research is crucial to the development of potentially innovative and life-changing medicines and vaccines we aim to deliver to the people who need them most.
People who volunteer to participate in clinical trials are generously sharing their time and experience with the aim of helping to better advance treatments for everyone. This is why we are deeply committed to their safety and to maintaining the highest standards of conduct across all our clinical trials.
We firmly believe that being transparent about our research and development allows other researchers to access the data, as well as serving the best interests of the people and patients who use our medicines.
Working ethically and openly
We established our commitment to clinical trial transparency in 2005, making information about our clinical research publicly available on our dedicated website astrazenecaclinicaltrials.com. We are also committed to disclosing our trial summary data on external public registries such as ClinicalTrials.gov and the EU Clinical Trials Register.
It is important we respect and uphold the principles developed by world health and regulatory organisations, as well as the pharmaceutical industry throughout our clinical trials. These include the Declaration of Helsinki, PhRMA Principles for Responsible Clinical Trial Data Sharing and the International Federation of Pharmaceutical Manufacturers & Associations Principles for Responsible Clinical Trial Data Sharing. All our clinical trial transparency policies meet industry standards while ensuring patient privacy and trial integrity.
We publish results from all our clinical trials on public registries such as ClinicalTrials.gov and the EU Clinical Trial Register, as well as in peer-reviewed medical and scientific journals, regardless of the outcome to support scientific advancement. We also publish easy to understand clinical Trial Result Summaries for study participants and the general public for at www.trialsummaries.com. AstraZeneca also has a long standing history of sharing anonymised individual patient level data with qualified researchers from trials of approved products in the US and EU, in support of our commitment to the Principles for Responsible Clinical Trial Data Sharing.
Bioethics is also a central component of our commitment to transparency in the way we conduct our biological and medical research and the care we take to act ethically and in full compliance of external regulations.
Maintaining the integrity of trials
Good Clinical Practice (GCP) and regulatory standards dictate the tight control of information around a clinical trial. While a trial is ongoing, it is imperative that certain details are not disclosed, in order to ensure the integrity of the trial. This is absolutely vital because the uncontrolled or premature release of information by researchers could inadvertently influence or bias the outcome of the trial, and thus make the results uninterpretable.
Many trials are ‘randomised’ which means study participants are randomly assigned into either a group receiving the investigatory medicine or a control group, also known as the placebo group. A ‘blinded’ trial means a participant does not know if they are receiving the investigatory medicine or a placebo. And a ‘double-blind’ clinical trial is where neither the participant nor the investigator knows if the participant is receiving the investigatory medicine. Blinding is an important component of many clinical trials to ensure that a subject’s knowledge of what treatment they have been assigned does not influence how they respond to emerging symptoms, jeopardising the validity of the trial.
The safety and efficacy of a medicine is continually being assessed against the entirety of all data collated for a medicine under development. Any potential signal that changes the overall benefit-risk profile of the medicine, as judged by the researchers and regulators may lead to modifying the study design, new safety monitoring, stopping the study, or possibly expedited approval.
During large clinical trials where thousands of participants are enrolled, people can fall ill for a multitude of reasons, even by chance. In order to understand if these events are caused by the investigatory medicine or not, it is critical to compare the event rate of any serious adverse effects in the group who received the medicine with those given a placebo. When events occur at a very low frequency, it is often not possible to ever conclusively determine what caused them
To ensure oversight of safety during the course of our clinical trials, a separate team of clinical experts, unrelated to the the trial is responsible for reviewing ongoing safety reports. Furthermore, the safety of the entire study can be overseen by an external, independent Data and Safety Monitoring Board (DSMB) responsible for monitoring patient safety and treatment efficacy data while a clinical trial is ongoing. Any new serious and unexpected events are immediately reported to health authorities, as well as to investigators at the trial sites, and also reported to all trial participants in the Informed Consent, when appropriate.
Patients are at the heart of our research
The Declaration of Helsinki clearly states: ‘It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.’
In an ongoing trial it is important that trial investigators and participants have relevant anonymised information shared with them in order for that medical research to progress to its full potential, while in the best interests of public health.
Safety data is always made public once every trial for the investigatory medicine has been completed. Upon approval of any new medicine by the health authorities, Patient Information is provided in appropriate, simple language alongside a marketed product. As a requirement to continue to market our medicines, we also commit to ongoing safety monitoring post marketing authorisation and keeping the Product Information up-to-date with any new information relating to the safe and effective use of our products.