ToxCrit

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.