09/16/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/japans-hybrid-dct-approach-shaped-by-unique-regulations-healthcare-system-and-geography 

Study finds only 18 Japanese institutions have hosted decentralized trials since 2021, with most combining traditional and remote elements.

Japan’s adoption of decentralized clinical trials has been slower than elsewhere, according to the authors of a new analysis, who suggest that investigators in the world’s third largest pharmaceutical market are pursuing a cautious approach.

The study surveyed more than 200 institutions about investigator-initiated decentralized trials and found that only 18 had hosted such studies since 2021.

It also showed that most of the 36 studies in question had been conducted at a Clinical Research Core Hospital or a National University Hospital.

The involvement of first-tier institutions makes sense, according to the authors, who wrote, “They are equipped with dedicated infrastructure, experienced research personnel, and well-established support systems for investigator-initiated clinical research.

“These institutional characteristics may have facilitated the adoption of novel trial methodologies such as DCTs [decentralized clinical trials], which require organizational capacity and expertise to implement.”

The analysis also indicates that, to date, few fully decentralized studies have been carried out in Japan. Instead, the focus is on combining certain decentralized elements — such as electronic informed consent — with more traditional trial designs.

For example, the analysis indicates that most of the studies — 75% — incorporated only one or two decentralized elements.

The focus on hybrid studies may, in part, be linked to the country’s demographics, according to the authors.

“Japan’s relatively compact geography and well-developed transportation infrastructure may mean that there is less need for fully remote trials than in larger, geographically dispersed countries.

“This could explain why the reported DCTs in our study predominantly adopted a hybrid model, integrating a limited number of decentralized elements into site-based trials, rather than pursuing fully remote designs,” they wrote.

DCT caution
The authors also noted that most studies covered in the analysis were conducted under ethical guidelines – which are a framework for research - rather than under the PMD Act or the Clinical Trials Act, which they suggest is indicative of a degree of caution.

“This pattern suggests that institutions may be cautiously experimenting with decentralized components in less stringently regulated research, potentially building experience before applying these methods to more complex IICTs [investigator-initiated clinical trials] or interventional studies under the Clinical Trials Act.

“This cautious approach is consistent with global reports that DCTs are more commonly used for lower-risk trials, such as those involving behavioral interventions, and that a substantial portion of DCTs globally is still focused on evaluating decentralized methods themselves rather than implementing them in further investigations,” the authors wrote.

Future
Whether the adoption of decentralized trials in Japan accelerates remains to be seen. However, a better understanding of the country’s clinical trial landscape will be critical, according to the authors.

“The adoption of DCTs is increasing, but appears to be characterized by a cautious, hybrid approach, primarily using eConsent and online consultations. This adoption pattern may reflect an approach adapted to Japan’s unique regulatory, healthcare, and geographical circumstances.

“Understanding the factors that have shaped this cautious, hybrid approach will be essential for informing future strategies to advance DCT implementation in Japan,” they wrote.