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Policy on Publications

Background

Publications are credible, evidence-based ways for Astellas to communicate the research results for our investigational and marketed products to the medical and scientific community. This policy is our roadmap to ensure that publications on these products are developed in co-operation with external investigators in a transparent, accurate, balanced and timely manner.
This policy adheres to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Research and Manufactures of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) principles on the conduct of clinical trials and communication of clinical trial results.

Policy

The results of Astellas’ clinical trials are made publicly available through both peer-reviewed publications and by disclosing results on public registries or websites. Peer-reviewed publications undergo rigorous review by the authors’ peers before acceptance and subsequent publication.

This policy provides guidance on how we interact and work with authors. Astellas follows the authorship criteria and recommendations set by the International Committee of Medical Journal Editors (ICMJE). Authors are identified early in the publication planning process and before writing commences. Authors have access to all relevant study data and are engaged at all stages of the publication development. Astellas does not compensate authors for the preparation or review of publications. Astellas’ commitment to transparency is further evidenced by our disclosure of study sponsorship, editorial assistance and funding. Likewise, authors must disclose financial support and funding received from Astellas and other organizations. Additionally, Astellas protects its intellectual property rights by mandatory reviews.

Astellas submits results on Astellas-sponsored research in a timely manner, regardless of outcome.


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