文部科学省科学技術振興調整費「京都大学・キヤノン協働研究プロジェクト」高次生体イメージング先端テクノハブ

Translational research (TR)

The Translational Research group will help to make efficient plans for clinical research and trials to confirm the effectiveness and safety for humans of novel diagnosis and treatment devices and probes according to their developmental stage and necessary/available pre-clinical data derived from animal experiments. The study for clinical demonstration on humans using prototype devices will be supported for the diagnosis and treatment departments of our hospital. This group will also support the planning, application procedure and execution of the clinical trials to promote the commercialization of the advanced medical devices and probes.

• Planning of clinical research and trials based on the development strategies

1) Consistency with the new Ethical Guidelines for Clinical Research
2) Effective early acquisition of Proof of Consent (POC)
3) Feedback of the clinical results to the teams of basic research, device and probe development

• Support for the consultation with regulatory authority (the Pharmaceuticals
  and Medical Devices Agency etc.) based on the development plans

1) Consistency with the Ministerial Ordinance on Good Clinical Practice (GCP) for Medical
Devices
2) Applying to exploratory clinical trials for medical devices and probes

Support for the legal practice of clinical research using non-approved medical devices
Utilizing of the special individual regulatory consultation provided for the Super Special Districts
Support for clinical research and physician-led trials of advanced prototype medical devices in development such as US-PAM, OCT
Utilizing of the Clinical Research Center for Medical Equipment Development and the Translational Research Center as Kyoto University Hospital infrastructure for clinical research and trials

Group

Akira Shimizu	Kyoto University Hospital, Professor	[Laboratory]
Masahiro Hiraoka	Graduate School of Medicine, Professor	[Laboratory]
Koji Kawakami	Graduate School of Medicine, Professor	[Laboratory]
Koji Shimizu	Graduate School of Medicine, Specially Appointed Professor	[Laboratory]
Kanako Mitani	Graduate School of Medicine, Assistant Research Staff	[Laboratory]