Optimal response-adaptive designs for continuous responses in phase III trials.
Optimal response-adaptive designs in phase III clinical trial set up are gaining more interest. Most of the available designs are not based on any optimal consideration. An optimal design for binary responses is given by Rosenberger et al. (2001) and one for continuous responses is provided by Biswas and Mandal (2004). Recently, Zhang and Rosenberger (2006) proposed another design for normal responses. This paper illustrates that the Zhang and Rosenberger (2006) design is not suitable for normally distributed responses, in general. The approach cannot be extended for other continuous response cases, such as exponential or gamma. In this paper, we first describe when the optimal design of Zhang and Rosenberger (2006) fails. We then suggest the appropriate adjustments for designs in different continuous distributions. A unified framework to find optimal response-adaptive designs for two competing treatments is proposed. The proposed methods are illustrated using some real data.
Biswas
Atanu
A
Applied Statistics Unit, Indian Statistical Institute, 203 B.T. Road, Kolkata 700108, India. atanu@isical.ac.in
Bhattachary
Rahul
R
Zhang
Lanju
L
D000700:Analgesics / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics / Q000379:methods*; D003198:Computer Simulation; D006801:Humans; D051474:Neuralgia, Postherpetic / Q000188:drug therapy; D010147:Pain Measurement / Q000379:methods; D000069583:Pregabalin; D012107:Research Design; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid