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Policy on Disclosure of Clinical Trial Data

Policy

At Astellas, we recognize 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 increasing transparency and sharing of clinical trial data. Realizing the full value of clinical trial data, such as scientific advancement and increasing innovation, requires that the data be accessible to the research community and others who might be able to use it. For this reason, Astellas has updated its global policy on the disclosure of clinical trial data. Astellas will comply with relevant laws, regulatory requirements and industry guidance, as well as the Astellas Global Code of Conduct, regarding the registration of clinical trial information and disclosure of clinical trial results.

This policy applies to all Astellas products, including those in-licensed from non-Astellas companies, and pertains to phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile of an Astellas product. For products where Astellas has a co-research, co-development or co-marketing/co-promotion agreement, it is recognized that the responsibility for disclosure is dependent on the agreement between parties. Astellas will endeavor to gain agreement on the principles set forth in this policy in arrangements with third parties, but at all times Astellas will comply with the relevant laws and regulatory guidance.

This policy does not apply to investigator-initiated trials for compounds in development or investigator sponsored research for marketed compound, as such trials are not sponsored or conducted by Astellas. Astellas, however, encourages the registration of these trials and the disclosure of results.

What is the Astellas policy for registering clinical trials?

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. Trials may also be registered on national registries, if required by local laws or regulations.

Astellas recognizes 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.

What is the Astellas policy for disclosing results of clinical trials?

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 EFPIA/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.

What is the Astellas policy for publishing results of clinical trials?

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.

How can the scientific community access clinical trial data?

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 anonymized 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.


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