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
Open this folder and view contents4. Other Issues and Considerations
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
Close this folderAnnex VIII. Guideline for Good Clinical Practicea
View the documentClinical Trial Protocol and Protocol Amendment(s)
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
 

Clinical Trial Protocol and Protocol Amendment(s)

General information

1. Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s).

2. Name and address of the sponsor and monitor (if other than the sponsor).

3. Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor.

4. Name, title, address, and telephone number(s) of the sponsor’s medical expert (or dentist when appropriate) for the trial.

5. Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).

6. Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator).

7. Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial.

Background information

1. Name and description of the investigational product(s).

2. A summary of findings from non-clinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.

3. Summary of the known and potential risks and benefits, if any, to human subjects.

4. Description of, and justification for, the route of administration, dosage, dosage regimen, and treatment period(s).

5. A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).

6. Description of the population to be studied.

7. References to literature and data that are relevant to the trial, and that provide background for the trial.

Trial objectives and purpose

A detailed description of the objectives and the purpose of the trial.

Trial design

1. The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include:

A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.

2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages.

3. A description of the measures taken to minimize/avoid bias, including:

(a) randomization
(b) blinding.

4. A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s).

5. The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.

6. A description of the “stopping rules” or “discontinuation criteria” for individual subjects, parts of trial and entire trial.

7. Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.

8. Maintenance of trial treatment randomization codes and procedures for breaking codes.

9. The identification of any data to be recorded directly on the case report forms (i.e. no prior written or electronic record of data), and to be considered to be source data.

Selection and withdrawal of subjects

1. Subject inclusion criteria.

2. Subject exclusion criteria.

3. Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and procedures specifying:

(a) when and how to withdraw subjects from the trial/investigational product treatment;
(b) the type and timing of the data to be collected for withdrawn subjects;
(c) whether and how subjects are to be replaced;
(d) the follow-up for subjects withdrawn from investigational product treatment/trial treatment.

Treatment of subjects

1. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial.

2. Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial.

3. Procedures for monitoring subject compliance.

Assessment of efficacy

1. Specification of the efficacy parameters.

2. Methods and timing for assessing, recording, and analysing of efficacy parameters.

Assessment of safety

1. Specification of safety parameters.

2. The methods and timing for assessing, recording, and analysing safety parameters.

3. Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.

4. The type and duration of the follow-up of subjects after adverse events.

Statistics

1. A description of the statistical methods to be employed, including timing of any planned interim analysis(ses).

2. The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and clinical justification.

3. The level of significance to be used.

4. Criteria for the termination of the trial.

5. Procedure for accounting for missing, unused, and spurious data.

6. Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate).

7. The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects).

Direct access to source data/documents

The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, institutional review board/independent ethics committee review, and regulatory inspection(s), providing direct access to source data/documents.

Quality control and quality assurance

Ethics

Description of ethical considerations relating to the trial.

Data handling and record keeping

Financing and insurance

Financing and insurance if not addressed in a separate agreement.

Publication policy

Publication policy, if not addressed in a separate agreement.

 

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