Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)
Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
Close this folder3. RESEARCH STUDIES
View the documentLITERATURE BACKGROUND
View the documentPROTOCOL PREPARATION
View the documentQUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATION
Open this folder and view contentsNON-CLINICAL STUDIES
Close this folderCLINICAL TRIALS USING HERBAL MEDICINES
View the documentCLINICAL TRIAL PROTOCOL DEVELOPMENT
View the documentPHASES OF A CLINICAL TRIAL
View the documentETHICS REVIEW BOARD
View the documentRESPONSIBILITIES OF INVESTIGATORS
View the documentRESPONSIBILITIES OF THE SPONSOR
View the documentDATA MANAGEMENT
View the documentSTATISTICAL ANALYSIS
View the documentREPORTING
View the documentEVALUATION OF HERBAL MEDICINE RESEARCH
Open this folder and view contentsTECHNOLOGY TRANSFER AND EDUCATION
Open this folder and view contents4. USING THE GUIDELINES
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY
View the documentSELECTED WHO PUBLICATIONS OF RELATED INTEREST
 

STATISTICAL ANALYSIS

Biostatistical expertise is required when the trial is designed, and must continue to be available as data are collected, analysed and prepared for the final report on the trial. Statistical considerations will govern the number of patients needed to obtain a significant result from the trial, the number of patients needed depending on the anticipated difference in the result between the treatment groups of the trial. The plan for the statistical analyses to be used at the conclusion of the trial must be determined in advance and specified within the protocol. When results are finally analysed, they should be presented in a form that facilitates clinical interpretation.

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