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.

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.

Trials Results

Since 2005, we have posted results of trials with already marketed medicines within one year of completion. 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.

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.

We have now evolved our support for external requests for data sharing by implementing the following:

  • AstraZeneca Group of Companies – Data Request Portal (leveraging our existing Trial Transparency system) to allow researchers to submit a request to access de-identified patient level data.
  • An independent Scientific Review Board 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 beyond that will continue to be reviewed by AstraZeneca on a case-by-case basis.

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 and TransCelerate, and updated as they continue to evolve 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.

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 allow 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.

Evolving our Transparency Policy

As a result of the EFPIA/PhRMA Responsible Data Sharing Principles as well as emerging EMA Policy and the new EU Clinical Trial Regulation, AstraZeneca continues to evolve and streamline its policies, processes and systems for Trial Transparency. In 2015, we implemented the following:

  • The production of Patient Engagement communications and Lay Language Summaries of clinical trial results, to be made available to all patients that participate in an interventional AstraZeneca sponsored clinical trial in the same language as their signed Informed Consent Form. Patients will receive a Thank You Note for participating in our trials, as well as ongoing study updates for certain studies, and the Lay Language Summary a year after the trial ends. In addition, all AstraZeneca Trial Result Summaries will be posted to www.trialsummaries.com and then to the EU portal when it comes online in 2017.
  • The reporting of clinical trials technical results regardless of drug approval status, in line with EudraCT requirements (12 months after Last Subject Last Visit).
  • The production of a redacted Clinical Report Package in accordance to the European Medicines Agency policy of October 2014. This will be posted to the EU portal within 30 days of Marketing approval (or MAA withdrawal) and a link will be made available from our website, www.astrazenecaclinicaltrials.com. The redacted Clinical Report package will include the Clinical Overview, Clinical Summary, CSR, Protocol, sample CRF and Study Statistical Analysis Plan and will be edited to remove proprietary information, or information that could be used to identify a patient.