Bridging Community And Central Hospitals With Japan's DCT Model

By Takuma Matsunaga, consultant in clinical trial digital transformation, Japan

In Japan, momentum for DCT adoption is steadily growing, particularly in oncology. Regulators issued guidance on eConsent in 2023, followed by recommendations on the use of remotely collected data in clinical trials in 2024. Discussions have also begun on requiring major hospitals to establish DCT-ready infrastructures, and several case examples have already been reported. Against this backdrop, a uniquely Japanese method has drawn attention: the “partner site model,” a community-based DCT framework developed to reflect the country’s regulatory and healthcare environment.

Differences From U.S. Satellite Sites: Japan’s Pragmatic Framework, The Partner Site Model

While the concept of satellite sites has long been familiar in the U.S., the Japanese approach represents a distinct framework that should not be confused with the same terminology. In the U.S., a satellite site is typically staffed with a sub-investigator (Sub-I), and contracts are executed directly between the principal investigator (PI) at the main site and the Sub-I at each satellite site. In Japan, however, under Japan’s GCP (J-GCP), clinical trial agreements must be executed between the sponsor and the director of each participating hospital.

Given these constraints, Japan has developed an alternative framework known as the partner site model. A partner site is not a trial-conducting institution but a regional hospital or clinic delegated with certain trial-related tasks. Legally, this model is grounded in Article 39-2 of Japan’s GCP, which allows task delegation through formal agreements.¹ In practice, partner sites perform supplementary functions that do not require advanced protocol or investigational drug expertise, and where operational variability across institutions is deemed acceptable. Because these activities remain under the oversight of the PI, the partner site model enables rapid network expansion and improved patient accrual without multiplying the number of full trial sites.

For example, in oncology trials targeting specific gene mutations — where patient enrollment can be particularly challenging — partner sites may conduct patient referrals and online prescreening. Patients in remote areas may undergo routine tests and follow-up visits at their local partner hospital, while connecting with the PI at the main trial site through telemedicine. This approach enhances patient accessibility while preserving the compliance and oversight required under Japanese regulations.

Advantages Of The Model

Although the partner site model requires additional effort during the initial contracting and infrastructure setup phase, it offers several important advantages:

• Broader patient access with fewer trial sites: The model enables wider geographic reach and patient participation without significantly increasing the number of full trial institutions.
• Psychological reassurance for patients: Allowing patients to join a trial through their familiar local hospital means their trusted physicians and staff remain actively involved. This helps offset the potential decline in patient engagement sometimes seen in fully remote DCTs where face-to-face visits are reduced.
• Continuity of care after the trial: When regional providers are already engaged during the study, follow-up and post-trial treatment can be more smoothly coordinated.
• Cost-effectiveness through existing community networks: Leveraging established regional infrastructures makes it possible to build a more efficient network-based DCT framework.
• Expanded role for local physicians: Partner physicians can present trial participation as one of the treatment options for their patients, further integrating clinical research into routine care.

In Japan, media reports have already highlighted fully remote oncology trials conducted in rural areas using this model.² These examples demonstrate how partner sites can lower the barriers to trial access, enable direct trial referrals to potentially eligible patients, strengthen community collaboration, and ultimately accelerate patient recruitment.

Looking ahead, further institutional clarification and standardization of the partner site model are expected as DCT adoption expands in Japan. Importantly, regulatory reforms are also under discussion. For instance, the upcoming 2025 revision of Guideline for Japan’s GCP is set to allow “partner pharmacies” under formal contracts to dispense investigational drugs to patients.³ This policy shift would significantly enhance the flexibility of Japan’s DCT ecosystem, enabling investigational product management not only at hospitals but also at regional pharmacies and partner medical institutions.

Overcoming Challenges In Implementation

To operate this model effectively, two elements are indispensable: a reliable framework for information sharing across institutions and robust quality management. The primary trial site must ensure consistency of data collected across multiple locations and appropriately integrate and share results from procedures and tests performed at partner sites. Japan’s clinical trials have long been recognized for their high data quality, and this cultural strength can also benefit DCTs. At the same time, however, the introduction of new IT tools and operational adjustments risks adding to the workload at trial sites. In practice, some sites have raised concerns about inefficiency when sponsors bring their own proprietary DCT systems, requiring staff to learn different tools for each trial. To address these challenges, Japan has begun promoting the concept of a standardized and interoperable “DCT ecosystem.” This approach seeks to build mechanisms that allow DCT implementation while leveraging systems that sites are already familiar with, thereby reducing the operational burden.

Another challenge lies in contracting and network establishment. Currently, each trial requires separate contracts between the lead hospital and its partner sites, resulting in lengthy preparation times. Building cooperative hospital networks during non-trial periods and making greater use of centralized IRBs (single reviews) could simplify contracts and review procedures.

From an operational perspective, risk management planning is particularly critical in industry-sponsored trials. Because experience with partner site trials in Japan is still limited, thorough discussions are necessary to establish clear delegation, oversight, and safety assurance frameworks with each institution. Safeguarding patient safety must remain the top priority. From the standpoint of data reliability, appropriate sharing and management of source documents between institutions is essential. Moving forward, the development and adoption of systems that comply with GCP requirements while minimizing the workload for partner sites will be crucial to sustainable implementation.

5 Keys To DCT Success In Japan

In shaping this model in Japan, several perspectives are essential — not only for advancing DCTs but also as lessons for companies seeking to launch new businesses in the Japanese market:

1. Build Trust Beyond Contracts

Rather than relying solely on contractual relationships between institutions, success depends on cultivating trust among healthcare professionals. By positioning sites as true partners, digital solutions can become a catalyst for activating broader regional collaboration. A true partnership is not merely a contractual relationship, but rather a commitment to breaking down barriers between institutions, building mutual trust, and working together toward shared goals. In practice, this means openly sharing information and challenges, supporting one another beyond assigned roles, and advancing clinical research as a collective effort across the entire region.

2. Navigate Institutional Consensus, Or “Nemawashi”

Understanding the consensus-building process unique to each Japanese hospital is critical. Nemawashi — the Japanese practice of informal, step-by-step consensus-building before formal decisions — highlights the importance of supporting early-stage adoption in a collaborative and hands-on manner, stakeholders can lower barriers to implementation.

3. Deliver “Operational Omotenashi”

Omotenashi is the Japanese spirit of thoughtful hospitality — anticipating needs before they are spoken. Applied to DCT, this means designing operations and tools that proactively ease the burden on CRCs and staff, creating a more supportive, patient-centered trial environment.

4. Communicate with Empathy

Instead of emphasizing “efficiency” or “cost reduction” from the sponsor’s perspective, communication should highlight patient access improvements and site workload relief. This patient- and site-centered framing is essential to enhancing site experience and driving adoption.

5. Invest in Sustainable Partnerships

Building relationships trial by trial often yields limited returns relative to the burden. Establishing continuous, long-term collaboration with regional sites creates a sustainable ecosystem for DCTs in Japan.

The Potential Of Japan’s DCT Model For Patient-Centered Trials

The partner site model is increasingly viewed as a promising approach to transform Japan’s clinical trials into more patient-centered studies while balancing two critical requirements: reducing operational burden and ensuring data quality. In selecting partner sites, human relationships remain just as important as technology. Rather than relying solely on remote tools, this model represents an approach aligned with Japan’s medical culture and institutional practices. Because facilities are geographically dispersed and often include regional hospitals with limited prior experience in clinical research, successful implementation requires intuitive UI/UX systems and operational excellence that can be applied consistently across diverse institutions. As operational experience grows, the partner site model has the potential to establish itself as a sustainable standard framework for DCTs in Japan.

If successful, this model could also strengthen Japan’s presence in global clinical development by demonstrating how patient-first trial designs can coexist with efficiency and compliance. Ultimately, the partner site model may become a key enabler of broader patient access to clinical trials, opening new doors of hope for patients who might otherwise be excluded.

References:

1. Japan MHLW “Handling of Medical Expenses Combined with Treatment Outside Insurance Coverage in Decentralized Clinical Trials” Published July 2024：kouseikyoku.mhlw.go.jp
2. “Kochi’s First Online Cancer Clinical Trial: Fully Remote Administration of Anticancer Drugs – Kochi University Hospital” August 2025: https://news.yahoo.co.jp/articles/236643c4cac8469193fffb94b09f224a76a6740c
3. Yakuji Nippo “MHLW Considers Allowing Investigational Drugs to Be Dispensed at Pharmacies as Part of GCP Revision.” Published March 26, 2025: https://www.yakuji.co.jp/entry116825.html

About The Author:

Takuma Matsunaga has over 10 years of experience in the healthcare and clinical research industry, with involvement in 50+ clinical trials across traditional, hybrid, and fully decentralized models. Actively involved in advancing DCT in Japan, he spearheads business growth and digital transformation of clinical trials at MICIN, Inc. He also supports the tele-oncology committee at the Japanese Telemedicine Society, helping to expand remote clinical trial capabilities. A frequent speaker at academic conferences and industry events, he shares insights on DCT implementation, regulatory challenges, and best practices. His mission is to advance patient care by transforming clinical trials through digital and remote innovations, making them more efficient and accessible than ever before.