The Japan Pharmaceutical Manufacturers Association (JPMA) announced the project today, explaining that it will use Medidata software to model site-to-site cost variation and compare the findings with data from the UK, the US and 17 Asia-Pacific countries.
The collaboration follows a JPMA report (here in Japanese) highlighting the various cost calculations and payment methods in use at different investigator sites, which it suggests are holding back drug development in the country.
Shingo Haseto, leader of the JPMA’s clinical evaluation taskforce, said: “As the Japanese clinical trial landscape evolves, it is increasingly important that we ensure consistent and fair payment—both for sponsors and sites.”
He added that a better understanding of the cost discrepancies will result in “increased transparency around clinical trial costs related to site performance.”
J-GCP vs ICH-GCP
Japan has its own good clinical practice standard – J-GCP – which while similar to International Conference on Harmonisation GCP standards (ICH-GCP) differ in some key respects.
The key differences – as they apply to trial sites in Japan – is the requirement that, in most cases, sites have their own institutional review board and the rule that site heads are responsible for signing all financial contracts.