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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S43] Virtual Clinical Trials: Roadmap for Implementation in Japan

Session Chair(s)

Takayuki  Imaeda, MPharm, MS

Takayuki Imaeda, MPharm, MS

  • Senior Director, Regulatory Affairs
  • 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.


Soyoku  Nobeyama, MSc

Direct-to-Patient Clinical Trial Model -Promises and Challenges-

Soyoku Nobeyama, MSc

  • Clinical Innovation Leader
  • Janssen Clinical Innovation, United States
Atsushi  Kitamura, MS

Implementation of “Home Visits” in Clinical Trials in Japan: Impact on Patients and Challenges

Atsushi Kitamura, MS

  • Clinical Study Innovation Lead, Clinical Operations
  • Pfizer R&D Japan, Japan
Haruo  Kuroki, MD, PhD

Virtual Clinical Trials: Roadmap for Implementation in Japan

Haruo Kuroki, MD, PhD

  • Director
  • Sotobo Child Clinic, Japan