Japan is rapidly moving into a society with a standardised digitalisation approach with modernised public services. This helps Japan to reinforce international competitiveness and also improves the convenience for Japanese citizens. This government led initiative towards digital transformation has helped in achieving a single administrative framework across Japan through the latest ‘Digital Agency’ initiative.

Japan’s vision to implement a digital society is to reform a user-friendly digitalisation culture. It helps government agencies, public entities and business operations to form a digital society which would help with sustainable development.  This revival is expected to change the working frame of many industries and sectors, with a positive impact on the healthcare and clinical research industry of Japan too. As positive measures by the Digital Agency, there is recognition of laws in protecting personal information and use of numbers for identifying specific individuals in administrative tasks and a national data strategy plan. 3H has already implemented operations in conducting de-centralised clinical trials and this initiative by the Digital Agency would rapidly give a new facelift to the traditional way of clinical trial conduct.

Digitalisation of healthcare in Japan: The healthcare sector of Japan is expected to further expand through digital transformation. The healthcare industry of Japan is worth 43.4 trillion yen. With the impact of the pandemic, the healthcare strategies and economy are further expected to increase, and Japan expects the industry to grow to 100 trillion yen by 2040. The government is expected to yield significant socioeconomic benefits through the process of digitalisation. Japan is promoting digitization of data in the long-term care, as well as disability fields, setting up systems for issue of digital prescriptions and the digitization of welfare services. These initiatives will improve services in telemedicine, tele-pharmacy, medical apps, devices, and the implementation of smart hospitals with artificial technology use.

3H has in-depth knowledge and expertise in conduct of de-centralised clinical trials. With the transformation of digitalisation in medical care, it is expected that the conduct of clinical trials will phase into a new era where decentralisation of clinical trials will increase. The factors to improve de-centralisation of clinical trials is enhanced by the initiatives of Digital Agency. It helps to make Japan more competitive in the global platform for clinical trial conduct.

Importance of going digital in clinical trial conduct: There are many shortcomings in the traditional clinical trial conduct. As clinical trials are the first step in introducing medical innovations and devices to the public, it is important that the conduct of clinical trials adheres to safety, compliance and data quality. These benchmarks help to overcome clinical trial conduct challenges and pitfalls.

Time: Time is a crucial factor in clinical trial conduct. It takes time in setting up systems and processes to generate clinical trial data and validate device safety and effectiveness. However, unlike before, digitalisation has helped to speed up enrolment and accelerate trial conduct. When the duration to complete a trial is less, the pharmaceutical agencies get to market the drugs and devices faster.

Enrolment: Digitalisation of clinical trials has helped with electronic consenting and passing of information electronically. This has accelerated the enrolment process and reduced costs associated with printing manual documents. The process of digitalisation helps patient evaluation from the comfort of home by using medical apps and devices. This flexibility helps in better patient participation and retention.

Infrastructure: Paper based processes are time consuming and cumbersome. There is a lot of financial burden involved with the conventional conduct of clinical trials. The process of digitalisation has helped in virtual conduct of clinical trials and the concept of patient-centricity, is improved through de-centralised clinical trial conduct. Digitalisation also helps with clinical trial data been stored securely. Developing documentation and setting up data capture systems, and ensuring compliance helps to speed the pace of study conduct.

3H’s contribution towards de-centralised digitalised clinical trial conduct in Japan: 3H is a pioneer in de-centralised clinical trial conduct in Japan. This patient-centric virtual clinical trial conduct has been possible through the use of digitalisation and latest technology. Use of home-based nursing care has assisted in having de-centralised satellite clinical sites where trained nurses visit clinical trial subjects in their homes. Smart wearables connected to a centralised system ensures patient vital signs are monitored on a real time basis by a physician. There is electronic source documentation by the nurses and the website Seikatsu-Kojo web helps in maintaining a database and pool of potential patients even in rare diseases and oncology.

Thus, in conclusion, the speed of digitalisation in the Japanese society is happening as a fast-track process following the pandemic. The recent initiative by the Digital Agency would streamline the administrative processes and digitalisation would ultimately improve healthcare and clinical trial conduct. Digitalisation has improved the rate of conduct of clinical trials, eased enrolment challenges and provided appropriate infrastructure to add flexibility to clinical trial conduct. 3H as a pioneer in modernising clinical trial conduct in Japan, is equipped with the latest technology knowledge and trained resources to support in conducting your clinical trials.

To learn more about how we may help you and your study, kindly reach us at imran@3h-ms.co.jp