crm12Comb

crm12Comb implements adaptive designs for integrated phase I/II trials of drug combinations using the Continual Reassessment Method (CRM) to guide patient assignment and conduct simulation studies for evaluating toxicity and efficacy.

Key Features:

• Patient Assignment Guidance: Supports patient allocation in a single trial based on existing accumulated data.
• Simulation Studies: Conducts extensive simulations with multiple trial parameters to evaluate operating characteristics and generate visual representations.
• Binary Outcome Modeling: Accounts for toxicity and efficacy as binary outcomes.
• Partial Ordering: Applies partial orderings to the dose-toxicity and dose-efficacy relationships for drug combinations.
• Flexible Parameter Specification: Allows user-specified parameters including maximum number of patients, cohort size, drug combinations, and various link functions with prior distributions.

Scientific Applications:

• Cancer Therapy Development: Speeds up drug development and enhances drug efficacy through adaptive phase I/II trial designs for drug combinations.
• Dose-Finding Studies: Leverages accumulated data within a Bayesian framework to guide patient allocation in dose-finding trials.
• Operating Characteristics Evaluation: Evaluates trial operating characteristics through simulation across diverse clinical scenarios.

Methodology:

crm12Comb uses the Continual Reassessment Method (CRM) within a Bayesian framework, applying partial orderings to dose-toxicity and dose-efficacy relationships for drug combinations with binary outcomes.