Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

[Phase II study]

H Niitani1

  • 1Headquarters of Foundation, Nippon Medical School, Tokyo, Japan.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|April 1, 1995
PubMed
Summary
This summary is machine-generated.

Japan's 1991 guidelines for anti-tumor drug clinical evaluations present practical challenges. This review highlights issues encountered during Phase II study development under these specific guidelines.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Cross-resistance to antineoplastic agents in a human small-cell lung-cancer subline resistant to okadaic Acid.

Oncology reports·2011
Same author

Randomised phase III trial of irinotecan combined with cisplatin for advanced non-small-cell lung cancer.

British journal of cancer·2003
Same author

The quality of life questionnaire for cancer patients treated with anticancer drugs (QOL-ACD): validity and reliability in japanese patients with advanced non-small-cell lung cancer.

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation·2002
Same author

A study of the combination of gemcitabine hydrochloride (LY188011) and cisplatin in non-small-cell lung cancer: 3-week schedule.

International journal of clinical oncology·2002
Same author

Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer.

International journal of clinical oncology·2001
Same author

Phase II study of S-1, a novel oral fluorouracil, in advanced non-small-cell lung cancer.

British journal of cancer·2001

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Regulatory Science

Background:

  • The Ministry of Health and Welfare of Japan established guidelines for anti-tumor drug clinical evaluation in February 1991.
  • These guidelines aim to standardize and ensure the quality of clinical trials for new anti-cancer medications.

Purpose of the Study:

  • To review and identify practical challenges encountered in developing Phase II clinical studies for anti-tumor drugs.
  • To assess the implementation of Japan's "Guidelines on Clinical Evaluation for Anti-tumor Drugs" from a researcher's perspective.

Main Methods:

  • Review of clinical studies conducted on new anti-tumor drugs.
  • Analysis of the practical aspects and challenges in Phase II study development based on the established guidelines.

Related Experiment Videos

Main Results:

  • Several practical problems were identified in the process of developing Phase II studies.
  • The review focuses on issues arising from adherence to the specific requirements of the 1991 Japanese guidelines.

Conclusions:

  • The practical application of the "Guidelines on Clinical Evaluation for Anti-tumor Drugs" presents specific challenges for Phase II study development.
  • Further refinement or clarification of the guidelines may be necessary to facilitate smoother drug development processes.