Are Decentralized Clinical Trials Taking Root in Japan?

Science 37 is advocating to improve patient participation and diversity via decentralized clinical trials. The American company has announced it is partnering with two Japanese contract research organizations (CRO) to expand its initiative in the country.

The new collaboration involves CMIC, the largest CRO in Japan, and 3H Medi Solution. While exact terms of the deal were not disclosed, it brings the two companies into Science 37’s CRO certified network, which provides training and commercial support for decentralized clinical trials. Furthermore, they will gain access to Science 37’s clinical trial Operating System (OS).

Science 37 believes its OS could help partners accelerate clinical studies by streamlining workflow and integrating data on a single platform.

Need for Decentralized Clinical Trials 

Clinical trials typically take place at a physical site, which could inconvenience participants who live farther away. In addition, this limits the number and diversity of patients enrolled in a study.

The ongoing COVID-19 pandemic further challenges the site-based model with restrictions on travel and face-to-face interactions. On the flip side, it is encouraging trial sponsors to embrace another approach.

Decentralized clinical trials could potentially address participation issues by connecting patients to investigators with digital technology. The model could be associated with telemedicine (remote delivery of medical consultations), the use of medical tracking devices and data collection, and the self-administration of trial medication.

“This collaboration will pave the way for promoting decentralized clinical trials in Japan, which is long overdue. It will help to reduce the patient burden, broaden the option for clinical trial participation, and speed drug development for the Japanese market,” said Sho Ando, Representative Director and President at 3H Medi Solution.

“With our partnership and utilizing the Science 37 Operating System and technology platform, we are able to more effectively orchestrate the user experience and workflows for patients, telemedicine investigators, and mobile nurses, generate requisite evidence and harmonize data all in one place,” said Yoshihito Kondo, Executive Vice President of Clinical Operation at CMIC.

Pioneer in Decentralized Clinical Trials

Founded in 2014, Science 37 has pioneered the decentralized clinical trial model. It has since collaborated with many CROs and pharmas, including Otsuka, Novartis, and Sanofi.

Earlier this month, the company completed its merger with LifeSci Acquisition II Corp., a special acquisition purpose company (SPAC), to list on the Nasdaq. The company is now trading under the ticker symbol “SNCE.” The listing raised $235 million, which the company said would fund its push for decentralized clinical trials.

Author

Joy Lin

Without knowledge, there is no imagination. Without imagination, knowledge is meaningless