Alessandro B. Antognini and Alessandra Giovagnoli, Adaptive Designs for Sequential Treatment Allocation. Boca Raton, FL: Chapman and Hall/CRC

Biometrics ◽  
2015 ◽  
Vol 71 (4) ◽  
pp. 1196-1197
Author(s):  
K.C. Carriere
Keyword(s):  
Adaptive Designs ◽  
Sequential Treatment ◽  
Treatment Allocation

Adaptive Designs for Sequential Treatment Allocation

2015 ◽  
Author(s):  
Alessandro Baldi Antognini ◽  
Alessandra Giovagnoli
Keyword(s):  
Adaptive Designs ◽  
Sequential Treatment ◽  
Treatment Allocation

scholarly journals Adaptive treatment allocation and selection in multi-arm clinical trials: a Bayesian perspective

2021 ◽  
Author(s):  
Elja Arjas ◽  
Dario Gasbarra
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Statistical Significance ◽  
Adaptive Designs ◽  
Critical Threshold ◽  
Attractive Alternative ◽  
Posterior Probabilities ◽  
Statistical Significance Testing ◽  
Treatment Allocation ◽  
Frequentist Paradigm

Abstract Background: Adaptive designs offer added flexibility in the execution of clinical trials, including the possibilities of allocating more patients to the treatments that turned out more successful, and early stopping due to either declared success or futility. Commonly applied adaptive designs, such as group sequential methods, are based on the frequentist paradigm and on ideas from statistical significance testing. Interim checks during the trial will have the effect of inflating the Type 1 error rate, or, if this rate is controlled and kept fixed, lowering the power. Results: The purpose of the paper is to demonstrate the usefulness of the Bayesian approach in the design and in the actual running of randomized clinical trials during Phase II and III. This approach is based on comparing the performance of the different treatment arm in terms of the respective joint posterior probabilities evaluated sequentially from the accruing outcome data, and then taking a control action if such posterior probabilities fall below a pre-specified critical threshold value. Two types of actions are considered: treatment allocation, putting on hold at least temporarily further accrual of patients to a treatment arm (Rule 1), and treatment selection, removing an arm from the trial permanently (Rule 2). The main development in the paper is in terms of binary outcomes, but extensions for handling time-to-event data, including data from vaccine trials, are also discussed. The performance of the proposed methodology is tested in extensive simulation experiments, with numerical results and graphical illustrations documented in a Supplement to the main text. As a companion to this paper, an implementation of the methods is provided in the form of a freely available R package. Conclusion: The proposed methods for trial design provide an attractive alternative to their frequentist counterparts.

scholarly journals Functional Sequential Treatment Allocation*

2020 ◽  
pp. 1-36
Author(s):  
Anders Bredahl Kock ◽  
David Preinerstorfer ◽  
Bezirgen Veliyev
Keyword(s):  
Sequential Treatment ◽  
Treatment Allocation

Sequential treatment allocation in clinical trials

Biometrika ◽  
1971 ◽  
Vol 58 (3) ◽  
pp. 419-426 ◽  
Author(s):  
B. J. FLEHINGER ◽  
T. A. LOUIS
Keyword(s):  
Clinical Trials ◽  
Sequential Treatment ◽  
Treatment Allocation
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