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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)
Soyoku Nobeyama, MSC
Clinical Innovation Leader, Janssen Clinical Innovation, United States
Direct-to-Patient Clinical Trial Model -Promises and Challenges-
Atsushi Kitamura, MS
Clinical Study Innovation Lead, Clinical Operations , Pfizer R&D Japan, Japan
Implementation of “Home Visits” in Clinical Trials in Japan: Impact on Patients and Challenges
Haruo Kuroki, MD, PHD
Director, Sotobo Child Clinic, Japan
Virtual Clinical Trials: Roadmap for Implementation in Japan