General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
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Table des matières
Afficher le documentAcknowledgements
Afficher le documentForeword
Ouvrir ce répertoire et afficher son contenuIntroduction
Ouvrir ce répertoire et afficher son contenu1. Methodologies for Research and Evaluation of Herbal Medicines
Ouvrir ce répertoire et afficher son contenu2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Ouvrir ce répertoire et afficher son contenu3. Clinical Research
Fermer ce répertoire4. Other Issues and Considerations
Afficher le document4.1 Pragmatic Research Issues
Afficher le document4.2 Ethics
Afficher le document4.3 Education and Training
Afficher le document4.4 Surveillance Systems
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuAnnexes
Ouvrir ce répertoire et afficher son contenuAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Ouvrir ce répertoire et afficher son contenuAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Ouvrir ce répertoire et afficher son contenuAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Ouvrir ce répertoire et afficher son contenuAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Ouvrir ce répertoire et afficher son contenuAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Ouvrir ce répertoire et afficher son contenuAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Ouvrir ce répertoire et afficher son contenuAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Ouvrir ce répertoire et afficher son contenuAnnex VIII. Guideline for Good Clinical Practicea
Ouvrir ce répertoire et afficher son contenuAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
Afficher le 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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Dernière mise à jour: le 3 mai 2013