Not just real world evidence, indispensable clinical trial: clinical trial

• Nakajima T.

  NHO Niigata National Hospital

• Tanno K.

  Health Data Scientist Association

• Watanabe M.

  Keio University

Bibliographic Information

Other Title

• リアルワールドエビデンスだけでなく治験の必要性
• clinical trial: clinical trial to post marketing observational study of HAL
• HAL 医療用下肢タイプの治験から使用成績調査へ

Abstract

With HAL (Hybrid Assistive Limb) as an example, we will discuss how to establish evidence for new medical devices. The use and evaluation method of HAL was constructed through a physician led clinical trial (NCY 3001) of the HAL medical lower limb type (CYBERDYNE Inc.). Since HAL has been shown to be effective and safe in 8 neuromuscular diseases in NCY 3001, the treatment with HAL has been covered by general health insurance Currently, we are exploring how the best long term effect can be obtained dependin g on the combination of other therapies, frequency and number of use of HAL, disease state, etc in the real world.

Journal

• Proceedings of the Conference of Transdisciplinary Federation of Science and Technology

  Proceedings of the Conference of Transdisciplinary Federation of Science and Technology 2019 (0), A-3-2-, 2019

  Transdisciplinary Federation of Science and Technology

Keywords

• HAL(Hybrid Assistive Limb)
• clinical trial
• real world evidence

Details

• CRID: 1390565134805178880
• NII Article ID: 130007762385
• DOI: 10.11487/oukan.2019.0_a-3-2
• Text Lang: ja
• Data Source:
  • JaLC
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed