Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, JAMA, vol.311, issue.4, pp.378-384, 2000. ,
Gatekeeping procedures with clinical trial applications, Pharmaceutical Statistics, vol.6, issue.3, pp.171-180, 2007. ,
Combining Multiple Comparisons and Modeling Techniques in Dose-Response Studies, Biometrics, vol.61, issue.3, pp.738-748, 2005. ,
Toxicity and Efficacy Probability Interval Design for Phase I Adoptive Cell Therapy Dose-Finding Clinical Trials, Clinical Cancer Research, vol.23, issue.1, pp.13-20, 2017. ,
Adaptive designs in clinical trials: why use them, and how to run and report them, BMC Medicine, vol.16, issue.1, p.29, 2018. ,
Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts, Biometrical Journal, vol.48, issue.4, pp.623-634, 2006. ,
Combining different phases in the development of medical treatments within a single trial, Statistics in Medicine, vol.18, issue.14, pp.1833-1848, 1999. ,
Practical considerations for optimal designs in clinical dose finding studies, Statistics in Medicine, vol.29, issue.7-8, pp.731-742, 2010. ,
Designs to balance cost and success rate for an early phase clinical study, Journal of Biopharmaceutical Statistics, vol.27, issue.1, pp.148-158, 2017. ,
Accounting for parameter uncertainty in two-stage designs for Phase II dose-response studies, Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects, pp.427-450, 2015. ,
An Adaptive, Dose-Finding, Seamless Phase 2/3 Study of a Long-Acting Glucagon-Like Peptide-1 Analog (Dulaglutide): Trial Design and Baseline Characteristics, Journal of Diabetes Science and Technology, vol.6, issue.6, pp.1319-1327, 2012. ,
A bayesian randomized clinical trial: A decision theoretic sequential design, Canadian Journal of Statistics, vol.32, issue.4, pp.387-402, 2004. ,
Response-adaptive clinical trials: case studies in the medical literature, Pharmaceutical Statistics, vol.16, issue.1, pp.64-86, 2017. ,
The Foundations of Statistics, INC, 1954. ,
Model-based dose finding under model uncertainty using general parametric models, Statistics in Medicine, vol.33, issue.10, pp.1646-1661, 2014. ,
Etude de la réponse aux médicaments par la modélisation des relations dose-concentrationeffet, pp.1-84, 2010. ,
Optimal Designs for Estimating the Interesting Part of a Dose-Effect Curve, Journal of Biopharmaceutical Statistics, vol.17, issue.6, pp.1097-1115, 2007. ,
Is It Possible To Estimate the Parameters of the Sigmoid Emax Model with Truncated Data Typical of Clinical Studies, Journal of Pharmaceutical Sciences, vol.85, issue.2, pp.232-239, 1996. ,
Adaptive designs for Dose-finding trials, pp.1-206, 2012. ,
Dynamic Programming, 1957. ,
Statistical Power Analysis for the Behavioral Sciences, 1988. ,