Home  Clinical trials
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Transparency of data
As part of our commitment to provide patients and healthcare professionals with meaningful information about our products, we make details about our clinical trials available on public websites. At the end of 2007, we had published information on the registration and results of more than 400 trials. These included hypothesis testing clinical trials, trials conducted in patients with a serious or life-threatening disease or condition, or non-interventional studies as defined by AstraZeneca.
In May 2008, we extended the scope of our disclosure to include information about the registration and results of all AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued.
Our commitment to publishing results, irrespective of whether they are favourable or unfavourable to AstraZeneca, remains unchanged.
Trial registration
Any new trial is posted within 21 days of the start of patient enrolment on the US National Library of Medicine's website ClinicalTrials.gov. Basic trial information is also posted on this website.
Trials results
Results of trials with already marketed medicines are published within 1 year of completion and results of trials with medicines in development will be published within 30 days of first regulatory approval for the new medicine or, when development has been discontinued, within 1 year of the public announcement of the decision. 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 this website, ClinicalTrials.gov and, for US approved medicines, the PhRMA website ClinicalStudyResults.org. Information is also provided on the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) portal ClinicalTrials.ifpma.org, which provides a single entry to trial registration and results information across the pharmaceutical industry.
Because we operate in an ever-changing environment, we will continue to monitor closely developments and advances in this area to ensure that AstraZeneca remains at the forefront of best practice in clinical trial transparency.
Please refer to the Glossary for further details of some of the terms used above.
Information from clinical trials posted on this website may, or may not, relate to uses that have been studied and approved by various regulatory agencies around the world. All countries have their own regulatory authority that undertakes a thorough review of clinical trial (and pre-clinical) data for all potential new pharmaceuticals. Due to differences in laws and regulations, national medical practice and culture, different regulatory authorities may reach different conclusions about the indications, patient population and usage for any given product within their jurisdiction.
The information contained in this site is not intended to promote or otherwise commercialize (directly or indirectly) any off-label or unapproved uses of AstraZeneca medicines. Prescription medicines must always be prescribed by healthcare professionals on the basis of the approved prescribing information in the relevant country. Clinical trials on AstraZeneca products may also be sponsored and reported by parties other than AstraZeneca and reported in other clinical trial registries.
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