BayesianMCPMod - Simulate, Evaluate, and Analyze Dose Finding Trials with Bayesian MCPMod

Bayesian MCPMod (Fleischer et al. (2022) <doi:10.1002/pst.2193>) is an innovative method that improves the traditional MCPMod by systematically incorporating historical data, such as previous placebo group data. This package offers functions for simulating, analyzing, and evaluating Bayesian MCPMod trials with normally and binary distributed endpoints. It enables the assessment of trial designs incorporating historical data across various true dose-response relationships and sample sizes. Robust mixture prior distributions, such as those derived with the Meta-Analytic-Predictive approach (Schmidli et al. (2014) <doi:10.1111/biom.12242>), can be specified for each dose group. Resulting mixture posterior distributions are used in the Bayesian Multiple Comparison Procedure and modeling steps. The modeling step also includes a weighted model averaging approach (Pinheiro et al. (2014) <doi:10.1002/sim.6052>). Estimated dose-response relationships can be bootstrapped and visualized.

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6.95 score 10 stars 7 scripts 247 downloads

bhmbasket - Bayesian Hierarchical Models for Basket Trials

Provides functions for the evaluation of basket trial designs with binary endpoints. Operating characteristics of a basket trial design are assessed by simulating trial data according to scenarios, analyzing the data with Bayesian hierarchical models (BHMs), and assessing decision probabilities on stratum and trial-level based on Go / No-go decision making. The package is build for high flexibility regarding decision rules, number of interim analyses, number of strata, and recruitment. The BHMs proposed by Berry et al. (2013) <doi:10.1177/1740774513497539> and Neuenschwander et al. (2016) <doi:10.1002/pst.1730>, as well as a model that combines both approaches are implemented. Functions are provided to implement Bayesian decision rules as for example proposed by Fisch et al. (2015) <doi:10.1177/2168479014533970>. In addition, posterior point estimates (mean/median) and credible intervals for response rates and some model parameters can be calculated. For simulated trial data, bias and mean squared errors of posterior point estimates for response rates can be provided.

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jagscpp

5.96 score 1 stars 3 dependents 17 scripts 654 downloads

tipmap - Tipping Point Analysis for Bayesian Dynamic Borrowing

Tipping point analysis for clinical trials that employ Bayesian dynamic borrowing via robust meta-analytic predictive (MAP) priors. Further functions facilitate expert elicitation of a primary weight of the informative component of the robust MAP prior and computation of operating characteristics. Intended use is the planning, analysis and interpretation of extrapolation studies in pediatric drug development, but applicability is generally wider.

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bayesian-borrowingbayesian-methodsclinical-trialevidence-synthesisextrapolationpediatricspharmaceutical-developmentprior-elicitationtipping-pointweighting

4.38 score 2 stars 12 scripts 170 downloads

BPrinStratTTE - Causal Effects in Principal Strata Defined by Antidrug Antibodies

Bayesian models to estimate causal effects of biological treatments on time-to-event endpoints in clinical trials with principal strata defined by the occurrence of antidrug antibodies. The methodology is based on Frangakis and Rubin (2002) <doi:10.1111/j.0006-341x.2002.00021.x> and Imbens and Rubin (1997) <doi:10.1214/aos/1034276631>, and here adapted to a specific time-to-event setting.

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bayesian-methodscausal-inferenceclinical-trialestimandmcmc-methodspharmaceutical-developmentprincipal-stratificationsimulationstantime-to-eventcpp

2.70 score 186 downloads