General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Close this folder4. Other Issues and Considerations
View the document4.1 Pragmatic Research Issues
View the document4.2 Ethics
View the document4.3 Education and Training
View the document4.4 Surveillance Systems
View the documentReferences
Open this folder and view contentsAnnexes
Open this folder and view contentsAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Open this folder and view contentsAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Open this folder and view contentsAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

4.1 Pragmatic Research Issues

The infrastructure for research in traditional medicine is significantly less developed than that for conventional medicine. However, there is now an increasing demand that the safety and efficacy of traditional medicine be determined, so that it can be considered by the public. In the development of traditional medicine, it is important that support be given to the establishment of appropriate infrastructure within the academic and other institutions of traditional medicine.

Other pragmatic issues that require consideration include funding, facilities, and involvement of properly trained research personnel and traditional medical practitioners.

Clinical research must be carried out under conditions which ensure adequate safety for the subjects. The institution selected must have adequate facilities, including laboratories and equipment, where necessary, and sufficient clerical, medical and allied health workers to support the study as required. Facilities should be available to meet any emergencies.

If a multicentre study is necessary, this may require a special administrative system to ensure that the study is conducted simultaneously and adequately at different sites by several investigators following the same protocol. It will be necessary to train investigators from different sites to follow the same protocol, and to standardize methods of patient selection, termination of patient participation, administration, and data collection and evaluation. Appropriate consultation about the statistical analysis is necessary during the planning, execution and assessment phases to ensure methodological consistency.

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