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Titolo:
Formal approaches to safety monitoring of clinical trials in life-threatening conditions
Autore:
Bolland, K; Whitehead, J;
Indirizzi:
Univ Reading, Med & Pharmaceut Stat Res Unit, Reading RG6 6FN, Berks, England Univ Reading Reading Berks England RG6 6FN eading RG6 6FN, Berks, England
Titolo Testata:
STATISTICS IN MEDICINE
fascicolo: 21, volume: 19, anno: 2000,
pagine: 2899 - 2917
SICI:
0277-6715(20001115)19:21<2899:FATSMO>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
SEQUENTIAL DESIGNS; END-POINTS; INFORMATION; RESPONSES; EFFICACY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
24
Recensione:
Indirizzi per estratti:
Indirizzo: Bolland, K Univ Reading, Med & Pharmaceut Stat Res Unit, POB 240, Reading RG6 6FN, Berks, England Univ Reading POB 240 Reading Berks England RG6 6FN rks, England
Citazione:
K. Bolland e J. Whitehead, "Formal approaches to safety monitoring of clinical trials in life-threatening conditions", STAT MED, 19(21), 2000, pp. 2899-2917

Abstract

Large clinical trials in life-threatening conditions are usually conductedunder the surveillance of a Data and Safety Monitoring Board (DSMB), whoseremit is to protect the ethical and safety interests of the patients. The purpose of this paper is to describe a formal approach to safety monitoring, using a sequential safety procedure to aid the decisions made by the DSMB. This procedure is designed to recommend termination of the study as soon as evidence that the experimental treatment is worse than the control in terms of the primary safety response is so strong that it is unethical to proceed. The use of this formal sequential procedure enables probabilities of the study stopping erroneously and stopping correctly, under various degrees of experimental treatment disadvantage, to be examined. Also scenarios depicting data sets which lead to continuing or stopping can be presented. Such explorations are useful in encouraging all DSMB members to consider carefully, prior to the start of a study, the conditions under which they wouldseriously wish to consider termination. The implementation of these methods is described for three recently completed trials in which it has been used. Finally, our current recommendations for the design of these procedures,arising from these and other similar experiences, are given. Copyright (C)2000 John Wiley & Sons, Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 08/04/20 alle ore 09:00:45