PriceDScottJ. The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: progress to date. Clin Trials.
2.
HutchinsonNVinarovEIasonosA, et al. Ethical and policy issues for seamless phase I oncology trials. J Clin Oncol2020; 38(7): 669–673.
3.
The Adaptive Platform Trials Coalition. Adaptive platform trials: definition, design, conduct and reporting considerations. Nat Rev Drug Discov2019; 18(10): 797–807.
4.
O’QuigleyJPepeMFisherL. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics1990; 46(1): 33–48.
5.
IasonosAWagesNAConawayMR, et al. Dimension of model parameter space and operating characteristics in adaptive dose-finding studies. Stat Med2016; 35(21): 3760–3775.
6.
WhiteheadJBrünierH. Bayesian decision procedures for dose determining experiments. Stat Med1995; 14(9): 885–893.
7.
GoodmanSNZahurakMLPiantadosiS. Some practical improvements in the continual reassessment method for phase I studies. Stat Med1995; 14(11): 1149–1161.
8.
ClertantMO’QuigleyJ. Semiparametric dose finding methods. J R Stat Soc Series B Stat Methodol2017; 79(5): 1487–1508.
9.
IasonosAO’QuigleyJ. Integrating the escalation and dose expansion studies into a unified phase I clinical trial. Contemp Clin Trials2016; 50: 124–134.