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[S43] Virtual Clinical Trials: Roadmap for Implementation in Japan
Session Chair(s)
Takayuki Imaeda, MPharm, MS
Head of Regulatory Sciences
Pfizer R&D Japan, Japan
Virtual clinical trial (VCT) is one of the hot topics in drug development as a way to enhance patients’ access to clinical trials. In contrast to several used cases available globally, only a few examples exist in Japan. In this session, we will discuss the benefits and obstacles to implement VCT in Japan from the study site and sponsor’s perspective after the global sponsor’s presentation. We will also introduce new technologies and approaches for VCT including eConsent, direct-to & from-patient, remote medicine, wearable device, ePRO, and smartphone apps and the challenges associated with them. Lastly, we will discuss the roadmap towards successful implementation, including what needs to evolve and potential disease areas, with key stakeholders from patients, study sites and pharmaceutical companies.
Speaker(s)
Direct-to-Patient Clinical Trial Model -Promises and Challenges-
Soyoku Nobeyama, MSc
Janssen Clinical Innovation, United States
Clinical Innovation Leader
Implementation of “Home Visits” in Clinical Trials in Japan: Impact on Patients and Challenges
Atsushi Kitamura, MS
Pfizer R&D Japan G.K., Japan
Director, Clinical Development Quality
Virtual Clinical Trials: Roadmap for Implementation in Japan
Haruo Kuroki, MD, PhD
Sotobo Child Clinic, Japan
Director