As a science-led biopharmaceutical company, our clinical research is crucial to the development of potentially innovative and life-changing medicines 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 have a long-standing commitment to making information about our clinical research publicly available. We believe that being transparent about our research and development allows other researchers to access the most up to date and relevant medical evidence, as well as serving the best interests of the people and patients who use our medicines.
Our vision is to be trusted for clinical trial transparency by regulators, investigators, participants, and society.
We deliver Clinical Trial Transparency by making clinical trial data, documents and results accessible to all within the framework of global regulations, policies, and industry best practices, and ensuring patient privacy and trial integrity. Our clinical trial transparency framework is guided by the Declaration of Helsinki and the EFPIA (European Federation of Pharmaceutical Industries and Associations) and PhRMA (Pharmaceutical Research and Manufacturers of America) joint Principles for Responsible Clinical Trial Data Sharing.
We meet our transparency commitments by publishing information on the registration, results and health authority submission activities relating to new and ongoing AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued.
AstraZeneca ensures clinical research is registered according to all global requirements:
We publish results from all our clinical trials on public registries, and, as often as possible in peer-reviewed medical and scientific journals, regardless of the outcome to support scientific advancement as follows:
We are continually evolving our processes to ensure we are meeting global regulations around sharing trial results.
Protocols are published according to global requirements and in additional situations as follows:
When publishing protocols, redactions may be applied to protect personal privacy and company confidential information.
In the US, the Statistical Analysis Plan are published for phase 2-4 clinical trials alongside the results on US National Library of Medicine’s website.
When publishing statistical analysis plans, redactions may be applied to protect personal privacy and company confidential information.
CSR Synopses are published by AstraZeneca as follows:
When publishing clinical study report synopsis, redactions may be applied to protect personal privacy and company confidential information.
In addition to sharing approved clinical documents with researchers on request, AstraZeneca is committed to meeting health authority requirements globally for the publication of clinical documents upon product review.
Both packages include the product Clinical Overview, Clinical Summaries of Safety and Efficacy, Clinical Study Reports and other types of reports such as PK/PD reports, Protocols, sample case report forms (CRFs) and Study Statistical Analysis Plans. The packages are anonymized to remove company confidential information and personal private information in line with global privacy laws.
In clinical research, it is important that trial investigators and participants have relevant anonymised information shared with them in order for medical research to progress to its full potential within the best interests of public health. AstraZeneca is committed to transparency for all stakeholders and voluntarily adopted the use of Lay Summaries as defined in the EU Clinical Trial Regulation (EU No 536/2014) in 2015.
Since April 1, 2015, all interventional clinical trials phase 1-4 with new protocols include the production of a Trial Result Summary, also referred to in the EU Clinical Trial Regulation as the Lay Summary of clinical trial results. These are made available to all patients that participate in an AstraZeneca sponsored clinical trial in the same language as their signed Informed Consent Form. All AstraZeneca Trial Result Summaries are posted to www.trialsummaries.com and to the EU Clinical Trial Information System (CTIS).
For all interventional studies started as of January 1, 2021, we are also committed to providing patients information about their treatment through the distribution of Unblinding cards after the study has completed.
Additionally, participants receive a Thank You Card and additional relevant communications in some studies.
For more information about patient centricity in clinical research at AstraZeneca, please read Our Commitment to Patients.
AstraZeneca is committed to the Responsible Data Sharing Principles as established by EFPIA and PhRMA. We have a long standing history of sharing anonymised individual patient level data with qualified researchers from trials of approved products in the US and EU.
Prior to 2015 we considered requests for de-identified patient level data from external researchers on a case-by-case basis, following consistent criteria to establish if and how the information provided will be used for valid scientific purposes and to benefit patients.
Since 2015, we support external requests through a more standardized process. We are now members of the Vivli platform and manage our requests as follows:
Anonymising datasets ensures we can fulfil our legal and ethical obligation to protect our patients when using patient data to advance medical research to its full potential. AstraZeneca guidelines for anonymising patient level data are derived from industry best practices provided by organizations such as PHUSE, TransCelerate, and EMA Policy 0070 Guidance. Our guidelines are regularly updated as knowledge, tools and best practices evolve in order to achieve integrity and anonymization of clinical data.
When sharing anonymised patient level data, complete datasets may not be shared as a result of any one of the following:
AstraZeneca supports requests for data using Vivli research platform. Vivli allows researchers access to data and the use of variety of best in class analytical tools through a remote desktop solution.
This platform supports compliance with our legal and ethical obligations as good data stewards to ensure protection of the data from download and potential misuse.
As of 31 December 2021, we have shared anonymized individual patient-level data from 165 studies, with 64 unique research teams and responded to 255 requests from external researchers.
These metrics are updated yearly in the first quarter of each year to reflect the previous year.