Transparency of trial information
AstraZeneca is committed to making information about our clinical trial activities publicly available.
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. These disclosure requirements are set out in our global Bioethics Policy and compliance is mandatory across the Company.
Because we operate in an ever-changing environment, we continue to monitor closely developments and advances in this area so that AstraZeneca remains at the forefront of best practice in clinical trial transparency.
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.
Trial results
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. 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 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.