Policy on Sharing Clinical Trial Data
Chugai Pharmaceutical believes that posting information about our clinical trials and sharing clinical trial data by an appropriate
method is vital for increasing the transparency of our clinical trials and gaining the trust of society.
Sharing clinical trial data with researchers also allows analysis based on the latest science and enables dissemination of findings about the applicable drugs and diseases, thus benefiting patients and improving healthcare.
In line with this stance, Chugai will post information about our clinical trials and share clinical trial data in accordance with Principles for Responsible Clinical Trial Data Sharing issued by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) on July 18, 2013, while observing the laws and regulations of individual countries and industry guidelines.
Posting of Clinical Trial Protocols and Results
Chugai will post a summary of the clinical trial protocol for trials in patients (excluding protocols for observational
research studies, as a rule) on the Chugai website and clinical trial registration websites.
Chugai will also post a summary of the results of trials of approved drugs on the Chugai website and clinical trial registration websites, irrespective of the results, if the protocol has been posted.
Sharing Clinical Trial Data with Researchers
- Chugai will share data from clinical trials in patients with external researchers. Access to clinical trial data will be provided after conclusion of an agreement with the researcher on clinical trial data sharing, provided that review by an independent review panel of experts concludes that the researcher qualifications, research objectives, and research protocol are all valid. This applies to clinical trial data (for trials conducted in Japan, the US, or Europe, including global trials) for drugs approved on or after January 1, 2014 (the effective date of Principles for Responsible Clinical Trial Data Sharing). However, data will not be shared if it is deemed that there is any risk of patients being identified.
- Data from clinical trials of products developed jointly with Roche may be shared with Roche. ( https://www.roche.com/)
- Data from clinical trials of products developed jointly with other entities will be shared only if the consent of the co-developer is obtained.
Disclosure of Clinical Study Reports
Chugai will provide external researchers, etc., with access to clinical study reports for drugs approved on or after January 1, 2014. However, reports will not be disclosed if it is deemed that there is any risk of patients being identified.
Publication of Clinical Trial Results
Chugai will publish the results of clinical trials in patients (including clinical trials of drugs for which development has been discontinued) in formats such as scientific papers if the clinical trial results are deemed to be medically important.