WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
(1995; 36 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentINTRODUCTION
View the documentGLOSSARY
Open this folder and view contents1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document2. THE PROTOCOL
Open this folder and view contents3. PROTECTION OF TRIAL SUBJECTS
Open this folder and view contents4. RESPONSIBILITIES OF THE INVESTIGATOR
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Open this folder and view contents6. RESPONSIBILITIES OF THE MONITOR
Open this folder and view contents7. MONITORING OF SAFETY
Open this folder and view contents8. RECORD KEEPING AND HANDLING OF DATA
Close this folder9. STATISTICS AND CALCULATIONS
View the document9.1 Experimental design
View the document9.2 Randomization and blinding
View the document9.3 Statistical analysis
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Open this folder and view contents11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
View the document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
View the documentREFERENCES
View the documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
View the documentAPPENDIX 2: Model list of items to be contained in a clinical trial protocol
 

9.3 Statistical analysis

The type(s) of statistical analyses to be used must be specified in the protocol, and any other subsequent deviations from this plan should be justified and described in the final report of the clinical trial. The statistical analysis should be planned and carried out or verified by an identified, appropriately qualified and experienced statistician. The possibility and circumstances of interim analyses must also be specified in the protocol.

The investigator and the monitor must ensure that the data are of the highest quality possible at the point of collection and the statistician must ensure the integrity of the data during processing.

The results of statistical analyses should be presented in such a manner as to facilitate interpretation of their clinical importance, e.g. as estimates of the magnitude of the treatment effect, the difference between treatments and confidence intervals, rather than in a form that relies solely on significance testing.

An account must be made of missing, unused or spurious data excluded during statistical analyses. All such exclusions must be documented so that they can be reviewed if necessary.

 

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