Disclosure Commitment

Transparency of Clinical Trial Information

AstraZeneca has a long-standing commitment to making information about our clinical research publicly available. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients.

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 by responding to global regulations, policies and industry best practices.

We meet transparency requirements globally during a study and for all health authority submission activities. We publish information on the registration and results of all 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. We are committed to the Principles for Responsible Clinical Trial Data Sharing.

Trial Registration

We register all Phase 1 to 4 interventional trials and qualifying non-interventional trials on the US National Library of Medicine’s website and European Union Clinical Trial Registry prior to the first patient being enrolled in a trial and to other websites globally within timelines as required by law. Additionally, all AstraZeneca sponsored clinical trials are listed on our dedicated clinical trials website, astrazenecaclinicaltrials.com.

Trial Results

We post clinical trial results in accordance to current global regulations, irrespective of whether they are favourable or unfavourable to AstraZeneca. We post results for all Phase 2 to 4 interventional studies on the US National Library of Medicine’s website and all Phase 1 to 4 trials on European Union Clinical Trial Registry per regulations and timelines. Additionally, all applicable AstraZeneca sponsored clinical trials results including Clinical Study Report Synopsis are posted on our dedicated clinical trials website, astrazenecaclinicaltrials.com. We continually evolve our process to ensure we are meeting result posting regulations globally.

  • Starting in 2005, we posted results of trials on clinicaltrials.gov, with already marketed medicines within one year of completion.
  • Since 2007 we have posted results for Phase 2-4 interventional studies, including observational studies, as required on the US National Library of Medicine’s website and other sites as required by law.
  • Starting in 2015, we posted clinical trials technical results to the EU Clinical Trial Registry, in line with EudraCT legal requirements.
  • Since 2017, we have posted results information of all 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.

Clinical Data and Clinical Study Reports Sharing

AstraZeneca is committed to the Responsible Data Sharing Principles as established by EFPIA and Pharma. Up until the start of 2015 we considered requests for de-identified patient level data from other parties 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.

Today we support external requests for our clinical study data and documents. We are committed to sharing in the following ways:

  • AstraZeneca Group of Companies allows researchers to submit a request to access anonymized patient level clinical data, aggregate clinical or genomics data (when available) and/or anonymized clinical study reports through Vivli 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 results, can be requested and will be considered for data and document sharing, including licensed and unlicensed products, when available.

In order for AstraZeneca to fulfill this commitment, AstraZeneca guidelines for anonymizing patient level data are derived from the industry best practices provided by organizations such as PHUSE, TransCelerate, Health Canada PRCI and EMA Policy 0070 Guidance. Our guidelines are updated as knowledge, tools and best practices evolve in order to achieve anonymization of clinical data. Anonymizing datasets enables us to fulfill our legal and ethical obligation to protect our patients whilst at the same time, utilizing patient’s data in progressing medical research to its full potential in the best interests of public health.

The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymization and sharing of the requested data or documents.

In the case of sharing anonymized patient level data, please note that the full dataset may not be shared in view of the following:

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

Finally, AstraZeneca has shared clinical data through the SAS Multi-Sponsor Environment historically and is using the Vivli research Environment to support new requests as of November 1, 2020. Both tools allow researchers access to the data and use of a variety of analytical tools through a remote desktop solution. Both environments allow AstraZeneca to fulfil our legal and ethical obligations as a good data steward, protecting the data from download and potential misuse.

As of 31 December 2020, we shared anonymized individual patient-level data from 160 studies, with 59 different research teams, in response to 199 requests for data.

Protocols, Statistical Analysis Plans and Study Synopsis

Starting in February 2013, we have voluntarily disclosed the research protocol for our clinical trials on astrazenecaclinicaltrials.com once a manuscript relating to results of the relevant trial on an investigational or approved product is published in a peer-reviewed medical journal. This policy also applies to observational studies published in peer-reviewed journals that have relevance to the efficacy or safety profile of an AstraZeneca product.

Currently the Study Protocol, Statistical Analysis Plan and CSR Synopsis are published with the results posting on applicable websites for clinical trial disclosure.

When sharing these clinical trial documents, redactions are 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 this means that AstraZeneca prepares a redacted Clinical Report Package in accordance to the European Medicines Agency Policy 0070 from October 2014. For more information on EMA Policy 0070 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 also published for products under review starting in 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 Summary, Clinical Study Reports and other types of reports such as PK/PD reports, Protocols, sample CRFs and Study Statistical Analysis Plans. The packages are anonymized to remove company confidential information and personal private information according to global privacy laws.

Transparency for Patients and the General Public

AstraZeneca is committed to transparency for all stakeholders. As such, AstraZeneca made a decision in 2015 to adopt the use of Lay Summaries as defined in the EU Clinical Trial Regulation, as well as additional transparency measure (EU No 536/2014).

As of 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 then to the EU Clinical Trial Information System (CTIS) when it comes online.

Additionally, participants will receive a Thank You Card as well as additional communications in some studies.

Transparency with patients is one of many patient centricity activity. For more information about patient centricity within AstraZeneca, please refer to the information enclosed in Our Commitment to Patients, on AstraZeneca’s corporate website.

History of AstraZeneca Clinical Trials Results Website

AstraZeneca’s commitments to transparency continue to evolve with regulations and best practices. The information contained within AstraZenecaclinicaltrials.com has evolved over time.

When this web site was first launched in 2005, AstraZeneca committed to post the key results of AstraZeneca-sponsored hypothesis-testing global clinical trials completed since April 1999 and local trials completed since January 2005 for all our approved medicines. The website also included local trials conducted under a US IND or NDA and completed since October 2002 and results of core safety and efficacy registration trials for medicines approved since the formation of the company in April 1999.

Since 2005, AstraZeneca has continually expanded the trial information it makes public, providing information about the registration and results of hypothesis testing trials, trials in patients with a serious or life-threatening disease or condition, and non-interventional trials as defined by AstraZeneca.

As of May 2008, AstraZeneca has made public information on all new and ongoing AstraZeneca-sponsored clinical trials for all products in all phases, including approved medicines, drugs in development and drugs whose further development has been discontinued.