Time-to-Event CRM (TITE-CRM)
A computational guide to the Time-to-Event Continual Reassessment Method (TITE-CRM), including partial follow-up weighting, Bayesian dose-toxicity modeling, posterior updating, dose assignment, operating considerations, and a complete worked example.
Time-to-Event BOIN (TITE-BOIN) Part 2: Case Study
A complete worked case study of the Time-to-Event Bayesian Optimal Interval (TITE-BOIN) design, following a hypothetical Phase I oncology trial from the first cohort through MTD selection using pending DLT information and standardized total follow-up time.
PK/PD Modeling for Dose Selection
A practical guide to PK/PD modeling for dose selection, including pharmacokinetic exposure, pharmacodynamic response, exposure–response relationships, Emax models, indirect response models, simulations, target attainment, and selecting doses for clinical development.
Optimal Biological Dose vs. Maximum Tolerated Dose
A practical guide to Optimal Biological Dose (OBD) versus Maximum Tolerated Dose (MTD), including dose-response relationships, dose-toxicity modeling, pharmacodynamic biomarkers, worked examples, and R implementation.
Modified Toxicity Probability Interval (mTPI) Design
A computational guide to the modified Toxicity Probability Interval (mTPI) design for dose-finding clinical trials, including the equivalence interval, Bayesian beta-binomial model, unit probability mass, dose escalation and de-escalation rules, a complete worked example, and R implementation.
Model-Assisted vs. Model-Based Dose-Finding Designs
A practical guide to model-assisted and model-based Phase I dose-finding designs, including BOIN, mTPI, Keyboard, CRM, TITE-CRM, dose-toxicity modeling, overdose control, simulation, and a worked comparison.
Maximum Tolerated Dose (MTD) Determination
A practical guide to maximum tolerated dose determination in Phase I clinical trials, covering dose-limiting toxicities, the 3+3 design, dose-escalation rules, MTD definition, operating characteristics, and modern model-based approaches.
Dose Expansion Cohorts in Oncology Trials
A practical guide to dose expansion cohorts in oncology trials, covering the transition from dose escalation to expansion, cohort objectives, sample size considerations, safety, efficacy, PK/PD, biomarkers, statistical operating characteristics, and a complete worked example.
Continual Reassessment Method (CRM)
A computational guide to the Continual Reassessment Method (CRM) for dose-finding clinical trials, including Bayesian dose-toxicity modeling, prior dose skeletons, posterior updating, dose selection, cohort escalation, operating characteristics, and a complete worked example.
Combination Dose-Finding Designs
A practical guide to combination dose-finding designs for early-phase clinical trials, including dose-combination matrices, toxicity targets, escalation rules, model-assisted and model-based approaches, operating characteristics, and a worked example.