Function reference • drugdevelopR

Basic setting

Optimally plan basic phase II/III drug development programs.

optimal_tte(): Optimal phase II/III drug development planning with time-to-event endpoint

optimal_binary(): Optimal phase II/III drug development planning with binary endpoint

optimal_normal(): Optimal phase II/III drug development planning with normally distributed endpoint

Bias adjustment

As phase III is only conducted in case of promising phase II results, treatment effect estimates from phase II generally overestimate the treatment effect. The following methods supply bias adjustment strategies for optimal program planning.

optimal_bias(): Optimal phase II/III drug development planning for time-to-event endpoints when discounting phase II results

optimal_bias_binary(): Optimal phase II/III drug development planning when discounting phase II results with binary endpoint

optimal_bias_normal(): Optimal phase II/III drug development planning when discounting phase II results with normally distributed endpoint

Multi-trial programs

More and more often, regulatory authorities require more than one confirmatory phase III study to have delivered a significant result. With the following methods, the planning of multi-trial programs can be optimized.

optimal_multitrial(): Optimal phase II/III drug development planning where several phase III trials are performed for time-to-event endpoints

optimal_multitrial_binary(): Optimal phase II/III drug development planning where several phase III trials are performed

optimal_multitrial_normal(): Optimal phase II/III drug development planning where several phase III trials are performed

Multi-arm trials

An efficient way of discovering effective treatments among a range of treatment choices is the conduct of multi-arm trials, which can be optimally planned using the following methods.

optimal_multiarm(): Optimal phase II/III drug development planning for multi-arm programs with time-to-event endpoint

optimal_multiarm_binary(): Optimal phase II/III drug development planning for multi-arm programs with binary endpoint

optimal_multiarm_normal(): Optimal phase II/III drug development planning for multi-arm programs with normally distributed endpoint

Multiple endpoints

In some trials, multiple endpoints may be of interest. Drug development programs with multiple endpoints can be optimized using the following methods.

optimal_multiple_tte(): Optimal phase II/III drug development planning for programs with multiple time-to-event endpoints

optimal_multiple_normal(): Optimal phase II/III drug development planning for programs with multiple normally distributed endpoints