Clinical trial conduct is a substantial investment requiring the right mix of resources and time. With the pharmaceutical industry facing many challenges in the Western world due to escalating costs and challenges in meeting the recruitment and retention of subjects, there is a trend in navigating clinical trial options in the Asian continent. Contract research organisations like 3H Medi Solutions help pharmaceutical companies in smoothly sailing through complex clinical trial processes and planning the right recruitment and retention strategies. Outsourcing has become an integral part of the biopharmaceutical industry, and in the Asian context the future trends in clinical research direction towards de-centralised clinical trial conduct with home-based nursing services to improve patient-centricity.

Drivers of Clinical Research in Asia: The Asia-Pacific CRO market is forecasted to expand to $11.9 billion by 2025. Some of the prominent indications are:

Improved regulatory efficiency: The faster regulatory approval processes today have helped clinical trials to be more available in a shorter time frame. 3H supports can accelerate pharmaceutical companies in obtaining clinical trial approvals within the stipulated timelines in Japan.

Large patient pool: Asia has a significantly large population with a heavy disease burden which makes it easy to identify and enrol subjects into the relevant clinical trials. The population is also inclusive of diverse ethnicities which represent a large gene pool. 3H has an established subject data base which helps to easily identify eligible subjects into the clinical trials.

Cost Effective: Service charges in conducting clinical trials in Asia is comparatively lower when compared to the West. Asia has a growing base of key opinion leaders who maintain high quality standards in clinical trial conduct. This gives pharmaceutical companies great value for money invested.

Clinical trial conduct: Trial activities can be de-centralised by using electronic consenting, re-consenting and withdrawing consenting of patients. Subject assessments can be done electronically using smart wearables. There is over 11000 units of smart wearables in use at the moment. And tele-medicine dispense. Subject monitoring can be done remotely too.

Decentralisation of clinical trials in Japan has helped the function of clinical trials by:

・ Enhancing the recruitment rate by 15 times making it easier to find potential subjects.

・ Improving retention of subjects by 28% due to improved patient centricity.

・The clinical trials have been able to recruit three times more subjects with diverse ethnicities than in the past.

・ Data reliability has improved while the workload of clinicians has decreased, improving clinician satisfaction levels.

Japanese subjects have an option to be part of decentralised clinical trials like in the western world

Highlights of 3H as a pioneer in de-centralised clinical trials in Japan: 3H is a clinical research company established in 2005. The company has come a long way and remains updated with the new trends in the clinical research industry to produce the desired outcomes for the pharmaceutical sponsors. The company has pioneered in initiating decentralised clinical trials in Japan. Some of the key highlights include:

・3H has executed 30+ Home Nursing Support projects in Japan

・Experienced in executing 24 hours of decentralised clinical trial support, performed during the pandemic

・ The exclusive partner of pioneer decentralised platform Global company in Japan

・Established a system support for the new corona vaccines and therapeutics drugs in Japan

・ Improved the quality of recruitment of new subjects while bringing in cost effectiveness

・ Joined the M3 Group on 1 Feb 2022 to strengthen its foundation

The Japanese landscape of clinical trial conduct is expected to move into digitalisation with the PMDA establishing guidelines for decentralisation of clinical trials. This moves Japan into embracing decentralisation of clinical trials.

3H collaboration with vendors to improve De-centralised Clinical Trial Experience: Nationwide there are over 970,000 registrants who have shown interest in participating in clinical trials in Japan and the 3H flagship website gains over 2 million views per month with referrals being made to the respective clinical trials. Thus, to improve the subject experience in participating in decentralised clinical trials, 3H has collaborated with global DCT vendors.

Partnering with Global DCT companies have helped 3H to become more agile in clinical trial conduct providing timely clinical trial solutions to pharmaceutical sponsors in meet the recruitment, retention and quality data which is needed for clinical trial success as well as it helped 3H to access an effective clinical trial technology system providing an end-to-end technology platform for e-consent, patient management, telemedicine and home-visit nursing.

Higher Subject Satisfaction Levels being part of De-centralized Clinical Trials: The subjects who take part in de-centralised clinical trials are happy with the shift of moving from a clinical trial site-based activity to a hybrid or virtual setup. A survey conducted by 3H showed that 60% of the respondents thought that decentralised clinical trials were a good initiative. The elderly subjects were however a little apprehensive on what to expect. The subjects were happy that decentralised clinical trials are a flexible option, with no wait time in hospitals while providing safety from the pandemic by cutting down on unnecessary travel. However, the subjects had a few concerns on being prepared to welcome the clinician at home and if the same doctors would be serving them. Privacy and security concerns were another concern.

Thus, with decentralisation of clinical trials happening rapidly the world over, Japan too is ready to walk with the world. 3H has already taken the necessary initiatives in partnering with technology giants to improve the experience and agility of clinical trial conduct. 3H welcomes pharmaceutical sponsors to join hands in conducting de-centralised clinical trials in Japan.

To learn more about how we can support your study, kindly reach us at imran@3h-ms.co.jp