The Way Forward for Decentralise Clinical Trials in Japan: As Decentralized clinical trials, brings participants the opportunity of participating in a clinical trial from the ease of their home or a local healthcare facility which is different to the traditional clinical trial site location far from the participant’s home. 3H, a Home-based clinical trial leader in Japan and in Asia has announced their subsidiary “Home Visit Uchiken” achieving accreditation on November 1st, 2023. This milestone strengthens 3H’s dedication to top-tier healthcare delivery in Japan. Traditionally, clinical trials have been limited to medical facilities only in prominent cities, making participation difficult for some living in the interiors. To address this, 3H has championed “home-based clinical trials” with visiting nurses since 2019. Through collaboration with Nursing Station, Medical institutions, and sponsors, 3H has established a unique system for home trials, partnering with local visiting nurse agencies. By October 2023, 3H had supported around 100 such trials.

3H as a reliable provider of decentralised clinical trials (DTC) in Japan has empowered participants through the use of latest technology. Seikatsu-Kojo Web hosts information on clinical trials held within Japan. It also contains information on from Food Product Development related information to clinical trials and health related information. Technology empowers patients, making them active partners through informed decisions and accurate data collection. Electronic diaries and wearables capture real-time, unbiased data from daily life, offering deeper insights compared to conventional clinical trial conduct.

Decentralised Clinical Trial Design Considerations: While the Covid-19 pandemic forced a rapid shift towards decentralized clinical trials (DCTs), 3H conducted a survey for acceptance of home healthcare support at the time of COVID. This was well accepted and successful.  Some strategies which helped DCT’s to success is

1.     Considering an Agile Design: 3H recognizes DCTs aren’t one-size-fits-all, thus prioritizing elements appropriate for decentralization is essential. Hybrid options like telemedicine for remote monitoring is in use while retaining in-person visits for specialized assessments. It is also helpful to consider offering both conventional and DCT arms within a single trial for wider participation.

2.      Developing a Proactive Strategy: It’s important to move beyond isolated, reactive efforts to a centralized, scalable plan for incorporating DCTs across programs. 3H leverages decentralised clinical trials through multiple investigator and patient networks to streamline site start-up and utilize remote teams for efficiency. Patient engagement proactive strategies help improved participation and better reporting of patient-reported outcomes.

3.     Regulatory Support: Regulatory support for DCTs are increasing as agencies actively encourage novel designs. It is important to engage with regulatory bodies early and often for smooth oversight, data collection, and safety adherence which 3H already does.

4.     Patient Centricity Takes More Than Technology: While technology enables patient-centricity, its deployment alone isn’t sufficient. It’s important to continuously  dialogue with patients, caregivers, and advocates to understand their needs and experiences. 3H uses social media platforms for patient and caregiver engagement. The decentralised clinical trial platforms are used to harmonize data, orchestrate interactions, and connect patients with relevant personnel. The level of patient-centricity is ultimately determined by human actions and interactions, not just technology. Thus, by proactively embracing these steps, we can ensure DCTs deliver on their promise: efficient, accessible, and patient-centered clinical trials that accelerate medical progress.

Keeping Trials on Track: Recruitment and Retention Strategies of 3H in DCT Recruitment and retention challenges affect clinical research at every stage, from patients to investigators and institutions. 3H has been able to provide innovative solutions to ensure smooth study flow and remove the below participant hurdles.

• Consent and understanding: Empowering participants on web platforms to extend knowledge of research awareness and remove the fear of clinical trials participation.
• Retention challenges: Pre-existing conditions, transportation issues, family support gaps, and side effects can lead to dropouts. This has been addressed by 3H’s P-Guardian application technology.

Overcoming Recruitment Challenges : Clinical trials often face hurdles in recruiting and retaining participants. 3H tackles these challenges with several solutions:

• Clinical Trial Educators (CTEs): 3H experts bridge communication gaps, ensuring patients understand the trial and make informed decisions.
• Decentralized & Hybrid Trials: Mobile services and home visits by 3H address logistical difficulties, increasing patient comfort and engagement.
• Home-based Participation: This option removes distance barriers, expanding recruitment and attracting a more diverse pool of participants.
• Patient-Centric Approach: Patient Recruitment expert champions patient needs, fosters collaboration with advocacy groups, and promotes inclusivity through decentralized trials and user-friendly technologies.
• Off-site Imaging & Monitoring: Utilizing home-based vitals monitoring and centralized facilities allows wider participation while maintaining data quality.

These solutions has helped 3H to promote efficient and inclusive clinical trials, ultimately accelerating medical progress.