A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints.
In an adaptive seamless phase II/III clinical trial interim analysis, data are used for treatment selection, enabling resources to be focused on comparison of more effective treatment(s) with a control. In this paper, we compare two methods recently proposed to enable use of short-term endpoint data for decision-making at the interim analysis. The comparison focuses on the power and the probability of correctly identifying the most promising treatment. We show that the choice of method depends on how well short-term data predict the best treatment, which may be measured by the correlation between treatment effects on short- and long-term endpoints.
a Warwick Medical School , University of Warwick , Coventry , United Kingdom.
Cornelia Ursula
CU
Kunz
Tim
T
Friede
Nicholas
N
Parsons
Susan
S
Todd
Nigel
N
Stallard
D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D018579:Patient Selection; D013997:Time Factors; D016896:Treatment Outcome
Adaptive seamless design; Multi-arm multi-stage trial; Surrogate endpoints