next_gBOIN_TB {UnifiedDoseFinding}

Determine the dose for the next cohort of new patients for single-agent trials that aim to find a maximum tolerated dose (MTD) defined by Toxicity Burden (TB) Score using gBOIN design

Description

Determine the dose for the next cohort of new patients for single-agent trials that aim to find the MTD defined by the toxicity burden (BT) score proposed by Bekele et al. (2004) using the generalized Bayesian optimal interval (gBOIN) design (Mu et al. 2017) . The algorithm of this function is exactly same to the next_mtd_gBOIN_Continuous() just the input parameter is used by the TB score

Usage

next_gBOIN_TB(target, n, y, d, mu_1 = 0.6 * target, mu_2 = 1.4 * target)

Arguments

target

the target TB score

n

the number of patients enrolled at each dose level

y

the toxicity score at each dose level

d

the current dose level

mu_1

the lower bound. The default value is 0.6 * target

mu_2

the upper bound. The default value is 1.4 * target

Value

next_gBOIN_TB() returns recommended dose level for the next cohort as a numeric value under ordinal measure

Author(s)

Chia-Wei Hsu, Haitao Pan, Rongji Mu

References

B. Nebiyou Bekele & Peter F Thall (2004) Dose-Finding Based on Multiple Toxicities in a Soft Tissue Sarcoma Trial, Journal of the American Statistical Association

Mu, Rongji, Ying Yuan, Jin Xu, Sumithra J. Mandrekar, and Jun Yin. "gBOIN: a unified model-assisted phase I trial design accounting for toxicity grades, and binary or continuous end points." Journal of the Royal Statistical Society. Series C: Applied Statistics 68, no. 2 (2019): 289-308.

Examples

target <- 3.344
n <- c(3, 9, 6, 0, 0, 0, 0, 0, 0, 0)
y <- c(5.5, 26.95, 25.3, 0, 0, 0, 0, 0, 0, 0)
d <- 2
next_gBOIN_TB(target = target, n = n, y = y, d = d)