New academic study proposes changes to the Early Access pathway in Japan

A recent paper in Patient Preference and Adherence by Hayashi et. al. interviewed 10 pharmaceutical company entities located in Japan to understand their perception and use of the Early Access Clinical Trials (EACT) pathway for compassionate use, and to establish their recommendations for improvements.

The EACT pathway is closely aligned to clinical trials legislation, is intended for groups of patients, requires a specific protocol, a clinical trial notification to the PDMA, and involves a lengthy ethics approval process.

The majority of respondents were in favour of amendments to the EACT legislation to make it more akin to the US Single Patient IND approach, to make the process more straight forward and increase the ease with which promising new medicines can be made available to patients in Japan.