Adaptive two‐treatment two‐period crossover design for binary treatment responses

doi:10.1111/J.1467-9574.2007.00360.X

Home
/
Papers
/
Adaptive two‐treatment two‐period crossover design for binary treatment responses

Journal Article•DOI•

Adaptive two‐treatment two‐period crossover design for binary treatment responses

Uttam Bandyopadhyay¹, Atanu Biswas², Shirsendu Mukherjee¹•Institutions (2)

University of Calcutta¹, Indian Statistical Institute²

01 Aug 2007-Statistica Neerlandica (Blackwell Publishing Ltd)-Vol. 61, Iss: 3, pp 329-344

TL;DR: In this paper, the authors used some adaptive designs in a two-treatment two-period crossover design where the treatment responses are binary and calculated the allocation proportions to the possible treatment combinations and their standard deviations.

read less

Abstract: Adaptive designs are sometimes used in a phase III clinical trial with the aim, of allocating a larger number of patients to the better treatment. In the present paper, we use some adaptive designs in a two-treatment two-period crossover design where the treatment responses are binary. We use some simple designs to choose between the possible treatment combinations AA, AB, BA or BB. The goal is to use the better treatment a larger proportion of times. We calculate the allocation proportions to the possible treatment combinations and their standard deviations. We also study related inferential problems. Related asymptotics are derived. The proposed procedure is compared with some possible competitors. Finally, we use real data to illustrate the applicability of our proposed design.

...read moreread less

Citations

PDF

Open Access

More filters

Journal Article•DOI•

Randomized Play-the-Winner Rule in Two-Period Two-Treatment Repeated Measurement Design

[...]

Uttam Bandyopadhyay¹, Atanu Biswas², Shirsendu Mukherjee³•Institutions (3)

University of Calcutta¹, Indian Statistical Institute², Behala College³

03 Apr 2016-Austrian Journal of Statistics

TL;DR: In this article, a randomized play-the-winner rule is used with a goal to allocate more patients to the better treatment in course of sampling, and the authors provide an application of this sampling scheme in repeated measurement design.

...read moreread less

Abstract: In the clinical trial randomized play-the-winner rule is used with a goal to allocate more patients to the better treatment in course of sampling. Here we provide an application of this sampling scheme in repeated measurement design. We concentrate on the simplest set up, i.e., on two treatments and two periods. We study, both numerically and theoretically, several exact and limiting properties of this design. We consider some related inferential problems. Finally we use a real data set to illustrate the applicability of our proposed design.

...read moreread less

5 citations

Cites methods from "Adaptive two‐treatment two‐period c..."

...An attempt towards this direction on two treatments and on two periods is made by Bandyopadhyay, Biswas, and Mukherjee (2007, 2009) for correlated binary responses using a combination of randomized play-the-winner (RPW) and play-the-winner (PW) rules....
[...]
...In the present work we modify Bandyopadhyay et al. (2007, 2009) by incorporating all the available data history (corresponding to both first and second doses of the treatments) to get any future first dose allocation....
[...]

Journal Article•DOI•

Nonparametric analysis of the two-period two-treatment crossover design

[...]

Uttam Bandyopadhyay¹, Suryasish Chatterjee¹•Institutions (1)

University of Calcutta¹

28 Jan 2015-Journal of Nonparametric Statistics

TL;DR: In this article, a nonparametric model for the analysis of the two-treatment, two-period, four-sequence crossover design was proposed and tests for the equality of treatment effects and for the absence of carryover effects were provided.

...read moreread less

Abstract: The paper describes a nonparametric model for the analysis of the two-treatment, two-period, four-sequence crossover design. Tests for the equality of treatment effects and for the absence of carryover effects are provided. Some relevant asymptotic results of the proposed tests are obtained and compared with the existing nonparametric and parametric competitors via simulation. It is shown that the proposed tests are comparable to or better than the competitors in terms of type I error and power.

...read moreread less

4 citations

Cites background from "Adaptive two‐treatment two‐period c..."

...Moreover, for recent developments, see, for example, the works of Putt and Chinchilli (2004), Tardif, Bellavance, and Eeden (2005), Bandyopadhyay, Biswas, and Mukherjee (2007) and Kawaguchi, Koch, and Ramaswamy (2009)....
[...]

Journal Article•DOI•

Crossover design in clinical trials for binary response

[...]

Uttam Bandyopadhyay¹, Joydeep Basu, Ganesh Dutta•Institutions (1)

University of Calcutta¹

06 Mar 2015-Journal of Applied Statistics

TL;DR: In this paper, a binary response model for the analysis of the two-treatment, two-period and four-sequence crossover design was proposed and two tests for the hypothesis of equality of treatment effects were provided.

...read moreread less

Abstract: In this paper, we consider a binary response model for the analysis of the two-treatment, two-period and four-sequence crossover design. We have introduced intra-patient drug dependency parameter in the model and provide two tests for the hypothesis of equality of treatment effects. We employ Monte Carlo simulation to compare our tests and a test that works under parallel design on the basis of type I error rate and power. We find that our procedures are dominant over the competitor with respect to power. Finally, we use a data set to illustrate the applicability of our procedure.

...read moreread less

3 citations

Journal Article•DOI•

A response-adaptive design in crossover trial

[...]

Uttam Bandyopadhyay¹, Atanu Biswas², Shirsendu Mukherjee³•Institutions (3)

University of Calcutta¹, Indian Statistical Institute², Behala College³

01 Oct 2012-Statistics

TL;DR: In this article, an adaptive allocation rule for a two-treatment two-period crossover design in the presence of possible carryover effects was proposed, which is a combination of the play-the-winner and randomized playthewinner rules.

...read moreread less

Abstract: In the present work, whenever the response variables are binary, we frame an adaptive allocation rule for a two-treatment two-period crossover design in the presence of possible carry-over effects. The proposed rule is a combination of the play-the-winner and randomized play-the-winner rules. We study various properties of the proposed rule through asymptotics and simulations. Some related inferential problems are also considered. The proposed procedure is compared with some possible competitor.

...read moreread less

2 citations

Cites background or methods from "Adaptive two‐treatment two‐period c..."

...[21,22] by incorporating all the available data history (corresponding to both first and second doses of the treatments) to get any future first-dose allocation....
[...]
...[21,22] for correlated binary responses using a combination of randomized play-the-winner (RPW) and play-the-winner (PW) rules....
[...]
...[21,22] studied that simple scenario under various parametric assumptions....
[...]

Journal Article•DOI•

Nonparametric approaches for comparing three-period, two-treatment, four-sequence crossover designs

[...]

Suryasish Chatterjee¹, Uttam Bandyopadhyay²•Institutions (2)

Bidhannagar College¹, University of Calcutta²

06 Feb 2019-Journal of Statistical Computation and Simulation

TL;DR: In this article, nonparametric approaches for comparing three-period, two-treatment, four-sequence crossover designs through testing the hypothesis that the treatments are interchangeable were described. The p...

...read moreread less

Abstract: The paper describes nonparametric approaches for comparing three-period, two-treatment, four-sequence crossover designs through testing the hypothesis that the treatments are interchangeable. The p...

...read moreread less

1 citations

References

PDF

Open Access

More filters

Journal Article•DOI•

The Theory of Rank Tests.

[...]

P. J. Bickel, J. Hajek, Z. Sidak

01 Mar 1969-Journal of the American Statistical Association

1,763 citations

Journal Article•DOI•

Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study.

[...]

Robert H. Bartlett¹, Dietrich W. Roloff¹, Richard G. Cornell¹, Andrews Af¹, Peter W. Dillon¹, Joseph B. Zwischenberger¹ - Show less +2 more•Institutions (1)

University of Michigan¹

01 Oct 1985-Pediatrics

TL;DR: In this paper, a prospective controlled randomized study of the use of extracorporeal membrane oxygenation to treat newborns with respiratory failure was carried out using the randomized play-the-winner statistical method, where the chance of randomly assigning an infant to one treatment or the other is influenced by the outcome of treatment of each patient in the study.

...read moreread less

Abstract: A prospective controlled randomized study of the use of extracorporeal membrane oxygenation to treat newborns with respiratory failure was carried out using the "randomized play-the-winner" statistical method. In this method the chance of randomly assigning an infant to one treatment or the other is influenced by the outcome of treatment of each patient in the study. If one treatment is more successful, more patients are randomly assigned to that treatment. A group of 12 infants with birth weight greater than 2 kg met objective criteria for high mortality risk. One patient was randomly assigned to conventional treatment (that patient died); 11 patients were randomly chosen for extracorporeal membrane oxygenation (all survived). Intracerebral hemorrhage occurred in one of 11 surviving children. Extracorporeal membrane oxygenation allows lung rest and improves survival compared to conventional ventilator therapy in newborn infants with severe respiratory failure.

...read moreread less

648 citations

Journal Article•DOI•

Extracorporeal circulation in neonatal respiratory failure: A prospective randomized study

[...]

Robert H. Bartlett, D.W. Roloff, R.G. Cornell

01 Mar 1987-Journal of Critical Care

TL;DR: A prospective controlled randomized study of the use of extracorporeal membrane oxygenation to treat newborns with respiratory failure using the "randomized play-the-winner" statistical method, which allows lung rest and improves survival compared to conventional ventilator therapy in newborn infants with severe respiratory failure.

...read moreread less

549 citations

"Adaptive two‐treatment two‐period c..." refers background in this paper

...…apparent, in that most of the real-life adaptive clinical trials (not crossover trials) to date are either by PW (unpublished application of Zelen in a lung cancer trial, reported by Iglewicz, 1983; Rout et al., 1993) or by RPW (Bartlett et al., 1985; Tamura et al., 1994; Biswas and Dewanji, 2004)....
[...]
...For our design, we use RPW for the first treatment and build up the urn using the allocation and response history of the first period of the earlier patients....
[...]
...In this adaptive allocation scheme, while updating the RPW urn for the first time point, we did not use information about the PW outcome for the second time point....
[...]
...Wei and Durham (1978) and Wei (1979) introduced the RPW rule, a modification of Zelen’s PW rule....
[...]
...The intuitive appeal and importance of these designs are apparent, in that most of the real-life adaptive clinical trials (not crossover trials) to date are either by PW (unpublished application of Zelen in a lung cancer trial, reported by Iglewicz, 1983; Rout et al., 1993) or by RPW (Bartlett et al., 1985; Tamura et al., 1994; Biswas and Dewanji, 2004)....
[...]

Journal Article•DOI•

The Randomized Play-the-Winner Rule in Medical Trials

[...]

L. J. Wei¹, S. Durham¹•Institutions (1)

University of South Carolina¹

01 Dec 1978-Journal of the American Statistical Association

TL;DR: In this article, a simple randomized treatment assignment rule is proposed and analyzed in a sequential medical trial, and on the average this rule assigns more patients to the better treatment, and it is applicable to the case where patients have delayed responses to treatments.

...read moreread less

Abstract: In a sequential medical trial, a simple randomized treatment assignment rule is proposed and analyzed. On the average this rule assigns more patients to the better treatment, and it is applicable to the case where patients have delayed responses to treatments. This new assignment rule is studied for both a fixed sample size and an inverse stopping rule.

...read moreread less

441 citations

Additional excerpts

...Wei and Durham (1978) and Wei (1979) introduced the RPW rule, a modification of Zelen’s PW rule....
[...]

Journal Article•DOI•

Play the Winner Rule and the Controlled Clinical Trial

[...]

M. Zelen¹•Institutions (1)

State University of New York System¹

01 Mar 1969-Journal of the American Statistical Association

TL;DR: Investigation of the conduct of a clinical trial where the “Play the Winner Rule” (PWR) is used to assign patients to the different therapies shows that over a wide range of situations this rule leads to near optimum results when used in a two-stage manner.

...read moreread less

Abstract: Consider a clinical trial to compare two treatments where response is dichotomous and patients enter the trial sequentially. This paper investigates the conduct of such a trial where the “Play the Winner Rule” (PWR) is used to assign patients to the different therapies. The implementation of the PWR in a clinical trial tends to place more patients on the better treatment. Both theoretical and numerical investigations show that over a wide range of situations this rule leads to near optimum results when used in a two-stage manner. Furthermore, these results are insensitive to optimum sample size requirements.

...read moreread less

436 citations