Disclosure Commitment

Evolving History of the AstraZeneca Clinical Trials Website

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.

On this website, since May 2008 AstraZeneca makes information public 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.

AstraZeneca’s commitments to trial transparency is shared by all members of the AstraZeneca group of companies, including all subsidiaries.

Transparency of 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.

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 post results, irrespective of whether they are favourable or unfavourable to AstraZeneca.

Trial Registration

Since June 2010, trials are registered on the US National Library of Medicine’s website prior to the first patient being enrolled in a trial and to other websites within timelines as required by law. We also post basic information on our own dedicated website, astrazenecaclinicaltrials.com. Additionally, AstraZeneca is compliant with all additional global registration requirements.

Trials Results

Since 2005, we have posted results of trials with already marketed medicines. Results of trials with medicines in development are posted within 30 days of first regulatory approval for the new medicine. When a medicine in development has been discontinued, results are published within one year of the public announcement of the decision, unless analysis and interpretation of the data are not sufficiently complete, in which case we post a brief explanation for the delay and the anticipated date when the results will be posted. For marketed medicines and recently approved medicines where we consider there to be good cause to delay posting of results, we will seek necessary approval according to applicable law. Where approved, we post a brief explanation for the delay and the anticipated date when the results will be posted.

Since 2007 we have posted results as required on the US National Library of Medicine’s website and other sites as required by law. Results of our studies of our small molecule products are also published on our dedicated website.

We post clinical trials technical results regardless of drug approval status, in line with EudraCT requirements (12 months after Last Subject Last Visit) and no later than 24 months after Last Subject Last Visit for Phase 1 studies.

We post redacted Clinical Study Synopsis for non-interventional studies on the ENCEPP registry one year after study is completed. We have been posting redacted synopsis for studies as since December 2015.

Trial Protocols

From 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. The posted protocol includes key sections necessary for evaluating the study, and proprietary information in the protocol, or information that could be used to identify a patient, is edited before posting. 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. When sharing any Clinical Trial documents, AZ Redaction Guidelines are applied which are based on industry best practices aimed at delivering the best data utility possible whilst ensuring the protection of personal private data.

Trial Data

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 Data Request Portal (leveraging our existing Trial Transparency System) allows researchers to submit a request to access de-identified patient level data and/or anonymized clinical study reports.
  • An independent Scientific Review Board is available to review and approve requests. The Scientific Review Board will review requests that go back as far as 2009 through this process.
  • All other requests for data prior to 2009 will continue to be reviewed by AstraZeneca on a case-by-case basis.
  • All AstraZeneca Sponsored studies can be requested and will be considered for data and document sharing, including licensed and unlicensed products.

In order for AstraZeneca to fulfill this commitment, AZ Guidelines for de-identification of patient level data are derived from the industry best practices today provided by organizations such as PhUSE,TransCelerate, and EMA Policy 0070 Guidance, Our guidelines are updated as knowledge, tools and best practices continue to evolve in order to achieve anonymization of clinical data. De-identifying 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 study request and can take up to a year upon full submission of the request for analysis, decision, de-identification and sharing of the requested data or documents.

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

  • Clinical consent for some countries prohibit secondary use of the data
  • Patients may withdraw their consent for participation in the trial at any point
  • Less than three quasi identifiers are shared per patient
  • Other aspects might also be taken into consideration to protect patient privacy (e.g. review of rare clinical events where information is aggregated to a higher-level before sharing)

Finally, AstraZeneca shares clinical data through the SAS Multi-Sponsor Environment, which is also an industry best practice solution. This tool allows researchers access to the data and use of a variety of analytical tools such as SAS, R, and other standards through a remote desktop solution. This environment allows AstraZeneca to fulfil our legal and ethical obligations as a good data steward, protecting the data from download and potential misuse.

As of December 2017 AstraZeneca has received 97 requests for sharing of individual patient level data. We have processed 74 of them, resulting is sharing of numerous sets of study data in response to 25 of these requests (34%). The remaining 23 requests were in analysis at year end.

Clinical Study Reports

Patients will receive a Thank You Note for participating in our trials, as well as ongoing study updates for some studies, and the Trial Result Summaries.

In addition to providing Clinical Study Report to requestors through our Data Request Portal, we disclose redacted Clinical Report Package in accordance to the European Medicines Agency EMA Policy 0070. This will be posted to the EU portal per EMA timelines and a link will be made available from our website, www.astrazenecaclinicaltrials.com. The redacted Clinical Report package includes the Clinical Overview, Clinical Summary, CSRs, Protocols, sample CRFs and Study Statistical Analysis Plans. These will be anonymized according to the guidelines and industry best practices.

Patient Communications and Trial Result Summaries

Patients will receive a Thank You Note for participating in our trials, as well as ongoing study updates for some studies, and the Trial Result Summaries.

Trial Results Summary, also referred to as Lay Language Summaries or Plain Language Summaries, explain what happened during a clinical trial in easy-to-understand language. It includes information about the purpose, results, and other facts about the trial. Trial Result Summaries will be made available to all patients that participate in an interventional AstraZeneca sponsored clinical trial in the same language as they received the Informed Consent Form. In addition, all AstraZeneca Trial Result Summaries will be posted to www.trialsummaries.com one to two years after the trial ends. Finally, these Lay Language Summaries will also be posted to the new EU portal per the EU Clinical Trial Regulation when it comes online.

Evolving our Transparency Policy

AstraZeneca will continue to evolve and streamline its policies, processes and systems for Trial Transparency. We monitor our compliance to policy through routine internal audits. We participate in the industry conversations and collaborations with Pharma, EFPIA, Transcelerate, Phuse and other groups around Trial Transparency and Disclosure and seek to continually adopt best practices, new policies such as the upcoming Health Canada Law, and new tools which enable Transparency for researchers, the public and regulatory compliance.

For more information about AstraZeneca’s Clinical Trial Transparency Commitments, please contact us as ClinicalTrialTransparency@astrazeneca.com