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.
Since June 2010, trials are registered on the US National Library of Medicine’s website (clinicaltrials.gov) 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. Information is also provided on the International Federation of Pharmaceutical Manufacturers and Association’s portal, which provides a single entry to trial registration and results information across the pharmaceutical industry.
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.
We have been, and continue to, consider requests for 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.
Calls for ‘open access’ to clinical data raise complex practical, legal and ethical issues around full disclosure of patient information. Decision-makers, as well as academia and industry have a duty to consider all the implications that could arise from such proposals. These include ensuring scientific rigour, safeguarding patient privacy and protecting innovation and medical progress. We continue to engage with regulators, legislators, industry, medical and scientific bodies to streamline and implement policies, standards, processes and systems to support responsible clinical trial data sharing that deliver real benefits to medical science and patients.
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. During 2015 we are working towards implementing the following:
- A Data Transparency Portal (leveraging our existing Trial Transparency system) to allow researchers to submit a request to access de-identified patient level data through a portal from www.astrazenecaclinicaltrials.com.
- A Scientific Review Board to review and approve requests. Once the request has been approved access to the de-identified data will be provided through a secure mechanism. We will support requests for trials starting in 2009 or later. Requests for data from earlier trials will be reviewed on a case-by-case basis.
- Lay Language Summaries of clinical trial results, to be made available to all patients that participate in an AstraZeneca sponsored clinical trial in the same language as their signed Informed Consent Form. These Lay Language Summaries will be posted to our website, www.astrazenecaclinicaltrials.com and then to the EU portal when it comes online in 2016.
- The ability to post Clinical Study Reports (CSR) and related documents to our website, www.astrazenecaclinicaltrials.com and then to the EU portal when it comes online in 2016. The CSR package will include the CSR, Appendix, 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.
What's next in this section
2013 data on our clinical trials activity.Read more