Clinical Trials Information
Policy on Disclosure of Clinical Trial Data
Astellas is committed to increasing transparency and sharing clinical trial data. Realizing the full value of clinical trial data, such as scientific advancement and increasing innovation, requires that the data be appropriately accessible to the research community and others who might be able to use it. We recognize that making this clinical trial data accessible to researchers, healthcare professionals, patients, and interested members of the public will benefit public health.
Astellas complies with relevant laws, regulatory requirements and industry guidance for registration of clinical trials, posting of clinical trial information, and disclosure of clinical trial results.
Registration of Clinical Trials
Astellas commits to registering all interventional clinical trials sponsored by Astellas that seek to evaluate the safety and/or efficacy profile of an Astellas owned or in-licensed product. Clinical trials sponsored by Astellas that are covered under this policy are registered on a publicly accessible clinical trial registry (e.g., www.clinicaltrials.gov). In addition, other Astellas sponsored studies (e.g., non-interventional studies) are registered on national registries, if required by local/regional laws or regulations.
Posting of Clinical Trial Results
Astellas commits to disclosing summary results for all phase 1 to 4 interventional clinical trials sponsored by Astellas, conducted in the target patient population, with Astellas products that have health authority approval. In addition, summary results for other Astellas sponsored studies (e.g., non-interventional studies) are disclosed on national registries, if required by local/regional laws or regulations.
Summary results and a plain language summary are posted on the Astellas clinical trial results website (www.astellasclinicalstudyresults.com) for clinical trials conducted with products that receive initial health authority approval after January 1, 2014. Summary results are publicly disclosed within 3 months after initial health authority approval is granted or within 12 months after trial completion for clinical trials conducted with product formulations and indications that previously received health authority approval. Additionally, summary results are posted on a publicly accessible clinical trial results website for trials conducted with products that received initial health authority approval from November 1, 2008 through December 31, 2013.
Summary results and a plain language summary are also disclosed on the Astellas clinical trial results website for clinical trials conducted with compounds that are terminated during development after January 1, 2014. Results are disclosed for completed trials within 12 months after compound development is terminated. Results are disclosed within 12 months after trial completion for clinical trials that are ongoing at the time that compound development is terminated.
Scientific Community Access to Study Data
Subject to compliance with the applicable laws and regulations relevant to protection of personal data, Astellas provides a platform (www.clinicalstudydatarequest.com) where researchers may request access to participant level data, trial level data and protocols from Astellas sponsored clinical trials conducted in patients that are completed after January 1, 2010.
Access to this datais granted for products and indications approved in any country after the request has been reviewed and approved by an independent panel of experts (“Scientific Review Board”) based on scientific merit and the qualifications of the researcher. Access is given by Astellas after review and approval by the Scientific Review Board and execution of a data sharing agreement.
Before participant-level data is shared, it is anonymized to respect the rights of the clinical trial subjects to privacy and to protection of their personal health information.