Disclosure Policy of the Astellas Group for Information on Conduct and Results of Clinical Trials.
The Astellas Group *1 (hereinafter collectively “Astellas”) recognises that making clinical trial information and results more widely available to researchers, healthcare professionals, patients, and interested members of the public will benefit public health. Therefore, Astellas is committed to publicly sharing data on clinical trials that are being performed under its responsibility. To meet this commitment, Astellas will comply with relevant laws, regulatory requirements and industry guidance for registration of clinical trial information and disclosure of clinical trial results.
The policy is as follows:
- Astellas commits to registering the existence of all Astellas sponsored phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile of an Astellas owned or in-licensed product. Trials sponsored by Astellas that are covered under this policy will be registered on a publicly accessible clinical trials registry (e.g., http://www.clinicaltrials.gov/). Trials may also be registered on national registries, if required by local laws or regulations. Astellas recognises that there are registries that extract information from various sources. Astellas cannot guarantee these registries are maintained with updated information or their accuracy, and accordingly disclaims any liability arising from use of these registries.
- Astellas commits to disclosing summary results of all Astellas sponsored phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile for Astellas products that have regulatory approval. This policy applies to products that receive regulatory approval after January 1, 2014 consistent with the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) principles for responsible clinical trial data sharing dated July 18, 2013, and includes the summary results for trials covered under this policy and included in the application to support regulatory approval. Summary results for trials completed after January 1, 2014 with products that received regulatory approval before this date will also be disclosed on a publicly accessible clinical trial results database. Summary results will be posted on a publicly available website, including national clinical trial databases as and when required by law or regulation. Astellas is working to provide a summary of clinical trial results for patients who participate in clinical trials and wish to receive a summary of the results. Astellas will continue to establish standards and operating procedures for creating these summaries for patients to ensure these are as useful and informative as possible.
- Astellas seeks to have clinical trial data of its sponsored trials presented and published, regardless of their outcome, at scientific congresses and in peer-reviewed journals.
- Subject to compliance with the applicable laws and regulations relevant to protection of personal data, Astellas will provide a platform where researchers may request access to patient level data, study level data and protocols from Astellas sponsored clinical trials conducted in patients that are completed after January 1, 2010. Access to this data may be 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 will be given by Astellas after review and approval by the Scientific Review Board and execution of a data sharing agreement. Before patient-level data is shared, it will be anonymised to respect the rights of the clinical trial subjects to privacy and to protection of their personal health information in accordance with the applicable laws and regulations.
(*1) Astellas Pharma Inc. and its group companies worldwide