Inference for a RPW‐Type Clinical Trial with Repeated Monitoring for the Treatment of Rheumatoid Arthritis

Abstract

SummaryThe present paper describes a controlled clinical trial to investigate the effect of Pulsed Electro-Magnetic Field for the treatment of sequentially entering patients with Rheumatoid Arthritis. According to the study design, repeated monitorings of the patients are carried out to assess their clinical status. The allocation of the entering patients to either a therapy group or a placebo group is done using a newly designed adaptive allocation rule termed as randomized longitudinal play-the-winner rule. A discussion of some inference procedures is followed by the analysis of a real data, which shows a clear preference of the therapy over the placebo.

Multi-treatment optimal response-adaptive designs for phase III clinical trials

“…None of these designs is suggested from an optimal view point, yet some of them are used in real clinical trials. In fact, almost all the real applications available in the literature are based on the PW (Rout, Rocke, Levin, Gouw's, & Reddy, 1993) and the RPW (Bartlett et al, 1985;Biswas & Dewanji, 2004;Tamura, Faries, Andersen, & Heiligenstein, 1994) rules. Some of the designs can also be very easily extended for more than two treatments.…”

“…These include the linear rank test statistic based design (Rosenberger, 1993), link function based design (Bandyopadhyay & Biswas, 2001), Wilcoxon score based design (Bandyopadhyay & Biswas, 2004), utility based design (Atkinson & Biswas, 2005), and the continuous dropthe-loser design (Ivanova, Biswas, & Lurie, 2006), among others. Real life applications of adaptive allocation designs are due to Bartlett et al (1985), Biswas and Dewanji (2004), Rout et al (1993) and Tamura et al (1994) among others.…”

Response-Adaptive Allocation for Circular Data

“…The available response-adaptive RESPONSE-ADAPTIVE ALLOCATION 831 designs for continuous response setup include the designs of Bandyopadhyay and Biswas (2001), Atkinson and Biswas (2005), Zhang and Rosenberger (2006). Real-life applications of adaptive designs include the works of Bartlett et al (1985), Tamura et al (1994), Rout et al (1993), and Biswas and Dewanji (2004), among others. Circular data is a natural occurrence in some clinical trials and biomedical problems.…”

Optimal Response‐Adaptive Designs for Normal Responses

“…The available designs for continuous responses are the linear rank test statistic based design (Rosenberger, 1996), link function based design (Bandyopadhyay and Biswas, 2001), Wilcoxon score based design (Bandyopadhyay and Biswas, 2004), and utility based design (Atkinson and Biswas, 2005), among others. Real life applications of adaptive allocation designs are due to Bartlett et al (1985), Rout et al (1993), Tamura et al (1994), Biswas and Dewanji (2004), among others.…”