Evolving History of the AstraZeneca Clinical Trials Website
When the 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.
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.
Since February 2013, AstraZeneca voluntarily discloses the research protocol for our clinical trials on this website, when a manuscript relating to an investigational or approved product is published in a peer-reviewed medical journal. The posted protocol includes key sections necessary for evaluating the study, but proprietary information in the protocol is edited before posting. This protocol posting policy also applies to observational studies published in peer-reviewed journals that have relevance to the efficacy or safety profile of an AstraZeneca product.
Since June 2010, trials are registered on the US National Library of Medicine’s web site (ClinicalTrials.gov) prior to the first patient being enrolled in a trial. Basic information is also posted on our dedicated website (AstraZenecaClinicalTrials.com).
Results of trials with already marketed medicines are posted 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 where trials have completed at least one year. 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.
Results are posted on our clinical trials web site, the US National Library of Medicine’s web site and other sites as required by law. 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.