Daniel Sabanés Bové, Roche, Basel, Switzerland
Ying Kuen Cheung, Columbia University, New York, NY
Philip Pallmann, Lancaster University, Lancaster, UK
Graham Wheeler, Cancer Research UK & UCL Cancer Trials Centre, University College London, UK & MRC
Description of Workshop
In this workshop we demonstrate the utility of the open access software R for designing and conducting early-phase dose finding studies. First we give an overview of CRM designs for single or multiple drugs, binary or time-to-event toxicity endpoints, and seamless phase I/II designs. The main focus of the session will be on practical examples and hands-on exercises. We illustrate all methods with data from real clinical trials and make full use of R and its add-on packages ‘dfcrm’, ‘bcrm’, and ‘crmPack’. We also demonstrate a ‘Shiny’ web application with a graphical user interface to compare the operating characteristics of 3+3 and CRM-type methods, and another one to design and carry out a CRM study without any knowledge of R.
Goals of session:
Participants should bring a laptop with the latest version of R (www.R-project.org) installed.
Statisticians and clinical investigators interested or involved in the planning, conduct, and evaluation of early-phase dose escalation studies. In-depth knowledge of statistical programming is not required for this course, but some basic familiarity with R may be helpful.