Description
Calculates Safety Stopping Boundaries for a Single-Arm Trial using Bayes.
Description
Computation of stopping boundaries for a single-arm trial using a Bayesian criterion; i.e., for each m<=n (n= total patient number of the trial) the smallest number of observed toxicities is calculated leading to the termination of the trial/accrual according to the specified criteria. The probabilities of stopping the trial/accrual at and up until (resp.) the m-th patient (m<=n) is also calculated. This design is more conservative than the frequentist approach (using Clopper Pearson CIs) which might be preferred as it concerns safety.See also Aamot et.al.(2010) "Continuous monitoring of toxicity in clinical trials - simulating the risk of stopping prematurely" <doi:10.5414/cpp48476>.
README.md
Safety Monitoring based on Bayes might be preferred compared to a frequentist approach, because it is more conservative, i.e. when the true toxicity rate is high, the probability to stop/interrupt the trial is higher when using the Bayes criterion as programmed in this package.
To use the function, the number of patients in the arm as well as the critical toxicity rate, the critical posterior probability of unacceptable toxicity, the number of simulations, the assumed true toxicity rate used for the simulations and the 2 parameters for the Beta distribution (default: both set to 1) are needed.