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Randomization in Cancer Clinical Trials : Permutation Test and Develop- Ment of a Computer Program

By Ohashi, Yasuo

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Book Id: WPLBN0000169431
Format Type: PDF eBook
File Size: 0.3 MB
Reproduction Date: 2005

Title: Randomization in Cancer Clinical Trials : Permutation Test and Develop- Ment of a Computer Program  
Author: Ohashi, Yasuo
Volume:
Language: English
Subject: Government publications, United Nations., United Nations. Office for Disarmament Affairs
Collection: Government Library Collection
Subcollection: Disarmament Documents
Historic
Publication Date:
Publisher: United Nations- Office for Disarmament Affairs (Unoda)
Description
Government Reference Publication

Excerpt
Excerpt: As seen in the guidelines by Simon and Wittes (I), high quality is being required in cancer clinical trial data for raising the reliability and comparability of trials, and this pressure from abroad is now influencing the design and management of cancer clinical trials in Japan. Until a few years ago, the randomization has been done almost exclusively by the envelop method in Japan, and a high rate of ineligibility and protocol violations have often deteriorated the reliability of the results. Recently, the central registration and randomization system by using a telephone call (or a facsimile) with a check of the eligibility criteria of each patient is rapidly spreading, and some medical researchers have a somewhat radical opinion that a trial by the envelop method is not scientifically evaluative.

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