Dose-escalation methods for phase I clinical trials
Organizer: Yinghui Zhou, Senior Research Fellow Medical and Pharmaceutical Statistics Research Unit, University of Reading, UK
Chair: Yinghui Zhou, Senior Research Fellow Medical and Pharmaceutical Statistics Research Unit, University of Reading, UK
Description: Traditional approaches to the design of phase I dose-finding studies take a long time to complete, and decisions on the escalation of doses are mainly based on clinical judgement. Efficient designs that gather sufficient information at higher doses that are of potential therapeutic value, while adequately protecting trial subjects, are currently developed. Since O'Quigley and his colleagues proposed the Continual Reassessment Method in 1990, researchers have developed various adaptive methods for oncology studies where each patient generates a single binary outcome. This symposium presents an evaluation of the CRM and generalisations for bivariate outcomes and healthy volunteer studies in which subjects are repeatedly dosed.
Speakers:
- Calibration of the Continual Reassessment Method Shing M Lee, Stastistical Consultant, Mailman School of Public Health, Columbia University, USA.
- Bivariate designs for early phase clinical trials Steve Coad, Reader in Statistics School of Mathematical Sciences, Queen Mary, University of London, UK.
- Bayesian procedures for dose-finding in phase I healthy volunteer studies Yinghui Zhou, Senior Research Fellow Medical and Pharmaceutical Statistics Research Unit, University of Reading, UK.
- Weighted Continual reassessment method Matthieu Resche-Rigon, Biostatistics Department, Saint Louis Teaching Hospital-Assistance Publique-Hopitaux de Paris, France.
