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Related Experiment Videos

[Post launch studies].

Hideyuki Akaza1, Yasuo Ohashi, Yasuhiro Shimada

  • 1Dept. of Urology, Institute of Clinical Medicine, University of Tsukuba, Japan.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|December 6, 2002
PubMed
Summary

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Evidence Based Medicine (EBM) in Japan requires better clinical study infrastructure. Initiatives focus on improving data generation and addressing regulatory challenges for post-launch trials.

Area of Science:

  • Clinical research and Evidence Based Medicine (EBM).

Context:

  • Evidence Based Medicine (EBM) adoption is increasing in Japan.
  • Conducting clinical studies post-launch faces numerous challenges in Japan.
  • Initiatives are underway to enhance the quality of clinical research.

Purpose:

  • To identify and address the key challenges hindering the effective implementation of Evidence Based Medicine (EBM) in Japan.
  • To explore necessary improvements in infrastructure, legal frameworks, and financial support for clinical studies.

Summary:

  • Japan's legal system for post-launch trials and off-label drug use is underdeveloped.
  • High costs, insufficient review systems for investigator-initiated studies, and differences in treatment practices pose significant hurdles.
  • Development of Clinical Research Coordinators (CROs) and data management centers are crucial.

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  • Despite challenges, researcher-initiated clinical trials are experiencing rapid growth.

    • Impact:

    • Enhancing the infrastructure for clinical studies is a priority to support researchers.
    • Addressing these issues is vital for advancing Evidence Based Medicine (EBM) in Japan.
    • Successful implementation can lead to improved healthcare and drug development in Japan.