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Shire’s Responsible Clinical Trial Data Sharing Commitment

April 9, 2015

Code of EthicsFor patients and physicians, participating in a clinical trial offers an opportunity to advance knowledge and treatment of life limiting illnesses.  Especially in the rare disease community, the enrollment and outcome of studies are closely followed.  Shire recognizes the importance for transparency in the conduct of clinical studies, notably the public access to trial information and the responsible sharing of data with patients, physicians, and researchers.

www.ShireTrials.com provides access to Shire-sponsored clinical trials and to answer questions about Shire’s approach to the sharing of clinical trial data. The website is designed to meet the Principles for Responsible Clinical Trial Data Sharing set forth by the European of Pharmaceutical Industries and Associations Federation (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

As part of these Principles, Shire has been working to enhance public access to clinical study information such as study design, entry criteria, study start and end dates, and study locations.  The website launched with a handful of studies and now has over 100 Shire-sponsored clinical studies listed. While some of these studies are actively recruiting patients, others represent completed studies dating back to 2004.  Additionally, Shire has established an internal infrastructure to ensure the efficient and consistent sharing of clinical trial information across websites such as ClinicalTrials.gov and ShireTrials.com. 

In addition to the sharing of study information, Shire has been focused on developing a process for sharing clinical trial results with patients and physicians as outlined in the Principles.  ShireTrials.com will provide links to clinical trial result summaries for a number of studies.

Shire’s commitment to transparency is evident in the steps taken to openly share the process and progress in clinical trials. We have a long-term commitment to patients and physicians and to the conditions our medicines treat. To learn more visit www.ShireTrials.com.