Planning controlled clinical trials.
Consensus Conference on Study Design and Evaluation of Clinical Trials on Prostate Cancer. Stockholm (SWE), 1996/09/12.
To address principles in the design and conduct of clinical trials on prostate cancer (PC) with special reference to localized disease.
In advance of and during the World Health Organization (WHO) conference on Prostate Cancer in Stockholm in September 1996,6 members of a working group evaluated and reached consensus on key points for the planning and conduction of controlled clinical trials in PC.
The key points discussed were 1) hypothesis formulation, 2) general methodological principles, 3) special problems of PC trials, 4) alternatives to randomization, and 5) trial organization.
The hypothesis must be clearly formulated and also clinically relevant enough to justify the expenses (in a broad sense) of a randomized clinical trial.
Patient selection, definition of endpoints, and sample size calculations must be carefully considered and correspond to the aims of the study.
Stratification on important prognostic factors should be contemplated.
Maintaining the accrual rate and ensuring compliance are critical for a quality study.
Survival is the main endpoint and intention to treat analysis is the standard methodology.
Secondary endpoints (eg, quality of life and costs) are important for the evaluation of many treatment modalities.
The use of surrogate endpoints for survival, such as prostate-specific antigen (PSA) elevation, may be misleading.
Surrogate endpoints require further validation. (...)
Mots-clés Pascal : Tumeur maligne, Prostate, Programme, Etude travail, Méthodologie, Evolution, Survie, Modalité traitement, Homme, Prostate pathologie, Appareil urinaire pathologie
Mots-clés Pascal anglais : Malignant tumor, Prostate, Program, Work study, Methodology, Evolution, Survival, Application method, Human, Prostate disease, Urinary system disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0347809
Code Inist : 002B14D02. Création : 12/09/1997.