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The use of local and nonlocal priors in Bayesian test-based monitoring for single-arm phase II clinical trials.

ABSTRACT: Bayesian sequential monitoring is widely used in adaptive phase II studies where the objective is to examine whether an experimental drug is efficacious. Common approaches for Bayesian sequential monitoring are based on posterior or predictive probabilities and Bayesian hypothesis testing procedures using Bayes factors. In the first part of the paper, we briefly show the connections between test-based (TB) and posterior probability-based (PB) sequential monitoring approaches. Next, we extensively investigate the choice of local and nonlocal priors for the TB monitoring procedure. We describe the pros and cons of different priors in terms of operating characteristics. We also develop a user-friendly Shiny application to implement the TB design.

SUBMITTER: Zhou Y

PROVIDER: S-EPMC9308506 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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The use of local and nonlocal priors in Bayesian test-based monitoring for single-arm phase II clinical trials.

Zhou Yanhong Y Lin Ruitao R Lee J Jack JJ

Pharmaceutical statistics 20210519 6

Bayesian sequential monitoring is widely used in adaptive phase II studies where the objective is to examine whether an experimental drug is efficacious. Common approaches for Bayesian sequential monitoring are based on posterior or predictive probabilities and Bayesian hypothesis testing procedures using Bayes factors. In the first part of the paper, we briefly show the connections between test-based (TB) and posterior probability-based (PB) sequential monitoring approaches. Next, we extensivel ...[more]

PMID: 34008317

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Project description:Background Multienergy computed tomography (MECT) is a promising imaging modality for material decomposition, lesion detection, and other clinical applications. However, there is an urgent need to design efficient and accurate algorithms to solve the inverse problems related to spectral reconstruction and improve image quality, especially under low-dose and incomplete datasets. The key issue for MECT reconstruction is how to efficiently describe the interchannel and intrachannel priors in multichannel images. Methods In this model, in order to correlate the similarities of interchannel images and regularize the multichannel images, the global, local, and nonlocal priors are jointly integrated into the low-dose MECT reconstruction model. First, the subspace decomposition method first employs the global low-rankness to map the original MECT images to the low-dimensional eigenimages. Then, nonlocal self-similarity of the eigenimages is cascaded into the optimization model. Additionally, the L0 quasi-norm on gradient images is incorporated into the proposed method to further enhance the local sparsity of intrachannel images. The alternating direction method is applied to solve the optimization model in an iterative scheme. Results Simulation, preclinical, and real datasets were applied to validate the effectiveness of the proposed method. From the simulation dataset, the new method was found to reduce the root-mean-square error (RMSE) by 42.31% compared with the latest research fourth-order nonlocal tensor decomposition MECT reconstruction (FONT-SIR) method under 160 projection views. The calculation time of an iteration for the proposed method was 23.07% of the FONT-SIR method. The results of material decomposition in real mouse data further confirmed the accuracy of the proposed method for different materials. Conclusions We developed a method in which the global, local, and nonlocal priors are jointly used to develop the reconstruction model for low-dose MECT, where the global low-rankness and nonlocal prior are cascaded by subspace decomposition and block-matching, and the L0 sparsity is applied to express the local prior. The results of the experiments demonstrate that the proposed method based on subspace improves computational efficiency and has advantages in noise suppression and structure preservation over competing algorithms.

Project description:BackgroundMulti-Arm Multi-Stage designs aim at comparing several new treatments to a common reference, in order to select or drop any treatment arm to move forward when such evidence already exists based on interim analyses. We redesigned a Bayesian adaptive design initially proposed for dose-finding, focusing our interest in the comparison of multiple experimental drugs to a control on a binary criterion measure.MethodsWe redesigned a phase II clinical trial that randomly allocates patients across three (one control and two experimental) treatment arms to assess dropping decision rules. We were interested in dropping any arm due to futility, either based on historical control rate (first rule) or comparison across arms (second rule), and in stopping experimental arm due to its ability to reach a sufficient response rate (third rule), using the difference of response probabilities in Bayes binomial trials between the treated and control as a measure of treatment benefit. Simulations were then conducted to investigate the decision operating characteristics under a variety of plausible scenarios, as a function of the decision thresholds.ResultsOur findings suggest that one experimental treatment was less efficient than the control and could have been dropped from the trial based on a sample of approximately 20 instead of 40 patients. In the simulation study, stopping decisions were reached sooner for the first rule than for the second rule, with close mean estimates of response rates and small bias. According to the decision threshold, the mean sample size to detect the required 0.15 absolute benefit ranged from 63 to 70 (rule 3) with false negative rates of less than 2 % (rule 1) up to 6 % (rule 2). In contrast, detecting a 0.15 inferiority in response rates required a sample size ranging on average from 23 to 35 (rules 1 and 2, respectively) with a false positive rate ranging from 3.6 to 0.6 % (rule 3).ConclusionAdaptive trial design is a good way to improve clinical trials. It allows removing ineffective drugs and reducing the trial sample size, while maintaining unbiased estimates. Decision thresholds can be set according to predefined fixed error decision rates.Trial registrationClinicalTrials.gov Identifier: NCT01342692 .

Dataset Information

The use of local and nonlocal priors in Bayesian test-based monitoring for single-arm phase II clinical trials.

Publications

The use of local and nonlocal priors in Bayesian test-based monitoring for single-arm phase II clinical trials.

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