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Related Experiment Videos

[Globalization of clinical trials].

Hideyuki Akaza1, Masahiro Fukuoka, Atsushi Ohtsu

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

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|May 2, 2003
PubMed
Summary

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Japanese clinical trials are advancing rapidly, especially in oncology. Global participation requires protocol harmonization, investigator involvement, and infrastructure improvements for successful drug registration in Japan.

Area of Science:

  • Oncology
  • Clinical Trials
  • Regulatory Science

Context:

  • Japanese clinical trial landscape shows rapid progress in lung, gastric, prostate, and breast cancers.
  • Significant differences exist between Japan and Western countries, and within Japan's clinical areas.
  • Bridging studies are crucial for regulatory approval, necessitating identical protocols.

Purpose:

  • To review the current state of clinical trials in Japan across major cancer types.
  • To identify challenges and propose solutions for enhancing Japanese participation in global oncology trials.
  • To facilitate international harmonization of clinical trial documentation and processes.

Summary:

  • Global phase III trials are key for drug registration in Japan, requiring early Japanese investigator involvement in protocol development.

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  • Clear protocols addressing clinical practice differences and focusing on hard endpoints like survival are essential.
  • Infrastructure development, including electronic data capture and dedicated trial centers, is vital for successful global trials.

    • Impact:

    • Addressing challenges in recruitment, infrastructure, and collaboration will optimize Japanese participation in global trials.
    • This optimization will enable Japanese investigators to initiate and lead international clinical studies.
    • Harmonization through evidence-based medicine and improved trial processes will benefit global oncology research.