Clinical Trials with an Adaptive Choice of Hypotheses

In a clinical trial with an adaptive interim analysis it is possible to modify not only the design, but even the hypothesis(es) of interest, in a formally correct manner. Two examples of clinical trials are described where modifications of hypotheses are based on substantial scientific reasons. Gene...

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Veröffentlicht in:	Drug information journal 2001-10, Vol.35 (4), p.1423-1429
Hauptverfasser:	Hommel, Gerhard, Kropf, Siegfried
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological and medical sciences Clinical trial. Drug monitoring Clinical trials Design modifications General pharmacology Hypotheses Medical sciences Pharmacology. Drug treatments
Online-Zugang:	Volltext
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Beschreibung
Zusammenfassung:	In a clinical trial with an adaptive interim analysis it is possible to modify not only the design, but even the hypothesis(es) of interest, in a formally correct manner. Two examples of clinical trials are described where modifications of hypotheses are based on substantial scientific reasons. Generally, it is emphasized that the danger of manipulation caused by flexible designs must be controlled by very restrictive guidelines.
ISSN:	2168-4790 0092-8615 2168-4804 2164-9200
DOI:	10.1177/009286150103500438