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 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.
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.
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.
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.
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:
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:
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.
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.
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: