Disclosure Commitment

Clinical Trial Transparency

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.

Registration Information

AstraZeneca ensures clinical research is registered according to all global requirements:

• We register studies on other websites globally within timelines as required by country laws.
• In the US, we register the following on the US National Library of Medicine’s website:
  • Phase 1 to 4 interventional trials
  • U.S. Early Access Programs
  • Observational trials involving AZ drug, or even studies between non AZ drug and other treatment options for clinical outcomes
  • Post Authorization Safety studies
• In the EU, we register all phase 1-4 trials that are conducted in European Economic Area (EEA) on European Union Clinical Trial Registry or the new EU Clinical Trial information System (CTIS), prior to the first patient being enrolled in a trial.
• All AstraZeneca sponsored interventional and above mentioned observational clinical trials are listed on our dedicated clinical trials website, astrazenecaclinicaltrials.com.

Technical Results

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 publish results on websites globally within timelines as required by country laws.
• In the US, we post results for all Phase 2 to 4 interventional studies on the US National Library of Medicine’s website.
• In the EU, we post results on European Union Clinical Trial Registry or the EU CTIS per regulations and timelines:
  • for all Phase 1 to 4 trials that are conducted in EEA.
  • for trials conducted outside the EEA if the trial is included in Paediatric Investigation Plan (PIP).
  • for paediatric studies involving the use of a drug approved for use in the EU and AZ is the Marketing Authorization Holder.
• All aforementioned AstraZeneca sponsored clinical trials results are posted on our dedicated clinical trials website, astrazenecaclinicaltrials.com.

We are continually evolving our processes to ensure we are meeting global regulations around sharing trial results.

Protocols

Protocols are published according to global requirements and in additional situations as follows:

• In the US, the Study Protocol are published for 2-4 clinical trials alongside the results on US National Library of Medicine’s website.
• In the EU, the protocols will be published on EU Clinical Trial information Systems (CTIS) in accordance with the EU Clinical Trial Regulation.
• Since February 2013, we have voluntarily disclosed research protocols for:
  • clinical trials on astrazenecaclinicaltrials.com once the results of the relevant trial on an investigational or approved product are published in a peer-reviewed medical journal.
  • observational studies published in peer-reviewed journals that have relevance to the efficacy or safety profile of an AstraZeneca product.

When publishing protocols, redactions may be applied to protect personal privacy and company confidential information.

Statistical Analysis Plans

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.

Clinical Study Report Synopsis

CSR Synopses are published by AstraZeneca as follows:

• In the US, on US National Library of Medicine’s website:
  • For all observational studies
  • For all phase 2-4 studies completed as of January 1, 2021
• On astrazenecaclinicaltrials.com:
  • For all Observational studies
  • For all phase 1-4 interventional studies completed as of January 1, 2021

When publishing clinical study report synopsis, redactions may be applied to protect personal privacy and company confidential information.

Clinical Document Publication

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.

• In the EU, AstraZeneca prepares a redacted Clinical Report Package in accordance to the European Medicines Agency Policy 0070. For more information on EMA Policy 0070 (October 2014) and the EMA Clinical data portal please refer to EMA portal.
• In Canada, under the Public Release of Clinical Information, a similar Anonymized Clinical Package is published for products under review (since 2019). This policy also allows for retroactive inquiries and publications under the policy. For more information, please refer to the Health Canada portal.

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.

Transparency for Patients and the General Public

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.

Data sharing for Researchers

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:

• AstraZeneca Group of Companies allows researchers to submit a request to access anonymized patient level clinical data, aggregated clinical or genomics data (when available) and/or anonymized clinical study documents through Vivli’s web-based data request platform.
• An independent Scientific Review Board is available to review requests.
• AstraZeneca sponsored studies for products that have been approved in the US and the EU are in scope for data request.
• Additionally, any AstraZeneca sponsored study, with published primary end point results, can be requested and may be considered for data and document sharing, including licensed and unlicensed products.
• The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymisation and sharing of the requested data or documents.

How do we prepare the data for sharing?

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:

• Patients may withdraw their consent for participation in the trial at any point.
• Clinical trial informed consent can prohibit secondary use of the data.
• Patient Privacy commitments require sponsors to manage risks and ensure patients are not identified. AstraZeneca is responsible for measuring the risk before sharing clinical data and documents.
• Other aspects taken into consideration to protect patient privacy (e.g., review of rare clinical events).

Why do we use Vivli?

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.

What are our Data sharing Metrics?

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.