Fujitsu says Japan needs digital trials ecosystem to combat ‘drug loss’
Fujitsu will leverage its partnership with Paradigm Health to make Japan more attractive for global trials and tackle the “drug loss” phenomenon that sees some international medicines fail to reach the local market.
The conglomerate said it will work with drug companies and medical institutions to build a data ecosystem for global trials in August, citing its partnership with US study tech startup Paradigm Health as key.
Fujitsu explained that combining Paradigm’s system with its own Healthy Living Platform and Kozuchi AI service will allow it to process data stored at medical institutions more efficiently, thereby accelerating the trial planning service it offers customers.
The Tokyo-headquartered firm also outlined plans for an automatic trial document creation service that uses its proprietary large language model (LLM) to help global trial sponsors comply with Japanese regulations.
Fujitsu will launch these solutions in September 2024, beginning with providing support to core clinical research hospitals.
Lag and loss
Winning drug approval in Europe and the US is faster than in Japan. According to recent analysis, Japanese approvals take an average of 1,547 days longer than in the US.
The difference, known as “drug lag,” is usually attributed to the combined impact of strict Japanese regulations requiring local studies and the country’s burdensome review processes.
“Drug loss,” in contrast, is when a developer decides not to launch a medicine that is approved elsewhere in Japan. Clearly there are many reasons for not launching in a particular market but, in Fujitsu’s view, the country’s trial rules are again at fault.
“In Japan, patients who participate in clinical trials are dispersed across multiple hospitals, making the process costly and time consuming. There has been an increasing number of cases in which Japan is excluded from regions targeted for global clinical trials. The impact of Japan’s drug pricing policy is also contributing to this situation.”
According to data from the Ministry of Health, Labour and Welfare of Japan, as of March 2023, 143 drugs that are in use outside of Japan have not been approved in the country.
Clinical revenue
Fujitsu framed its plan as part of a wider effort, explaining that it also plans to provide sponsors with clinical trial planning and implementation services. The firm predicted it would secure 20 billion yen in revenue in fiscal 2030.
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