Japan has historically been behind the US and EU when it comes to using DCT for drug research. To date, Japanese clinical trials have been only done at a limited number of hospitals. This means that patients oftentimes need to commute a long time to participate thus leading to large travel expenditures or a decline in trial participation. For rare cancers or other genomic diseases, this limits the pool of participants and hence drug research. In addition, while clinical trial information is well-known and easily accessible in the West, Japan’s decentralized clinical trial information makes it difficult for patients to know where and when they need to go to participate.
As a result, Japan is now interested in building a better DCT ecosystem. In this new Japanese DCT system, sponsors, sites, and patients need to see the benefits and coordinate together. One solution includes having vendors or hospitals to meet standard criteria on DCT compliance. By doing this, Sponsors will feel more comfortable with the accuracy of the data. Japan’s DCT wants to utilize and leverage more automation, telemedicine, AI, home-based care, etc. Thus, DCTs in Japan will include more remote screening and online consultations and allow for a more patient-friendly process. Japan’s fifth, 10-year cancer research strategy specifically supports electronic informed consent, home-based trials, data collected remotely, etc.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.