Phase I and Phase I/II dose finding studies: theory and applications
Presenters:
John O'Quigley, Université Pierre et Maire Curie-Paris VI, Paris, France.
Alexia Iasonos, Memorial Sloan Kettering Cancer Center, New York, USA.
Ken Cheung, Columbia University, New York, USA
The course presenters have broad and varied experience in the area of early phase dose-finding studies. John O'Quigley has published extensively on the statistical methodology of different types of dose-finding designs. Alexia Iasonos has contributed both to the theoretical and applied literature on this topic. Alexia, a winner of the Pharmaceutical Research Institute Star Award during her time with Bristol Myers Squibb, now plays a leading role in the implementation of innovative dose-finding designs at the Memorial Sloan Kettering Cancer Center. Ken Cheung, author of the recent Chapman and Hall text 'Dose finding using the Continual Reassessment Method', has made significant contributions to the statistical literature on this topic. Ken has also overseen the design and analysis of many dose-finding studies in practice and was the first to promote the use of innovative designs in the field of neurology.
Date: Tuesday November 20th 2012
Venue: British Medical Association House, Tavistock Square, London (walking distance from St Pancras, Euston and King's Cross)
This course will cover basic concepts behind Phase I clinical trials, dose finding studies in humans, in various disease settings. The topic has received increased attention in the statistical literature and as a result there exist many new designs that one can choose from. The morning session will start with a review of current designs, concepts and endpoint definitions as well as an overview of different types of trials and aims. Model based designs such as the Continual Reassessment Method (CRM) will be described and some theoretical concepts will be covered at an introductory/intermediate level. Illustrations on how to design, implement and carry out a model based Phase I trial in practice will be provided based on actual studies from oncology, HIV, stroke, and alcoholism. These applications will lead to a discussion about lessons learned, problems and solutions based on case studies. The afternoon session will cover more advanced topics such as studies involving more than one drug or schedule, drug combinations, patient heterogeneity, Bayesian model average, non drug related toxicities. The last hour and a half will be split into parallel sessions: one covering protocol development, computational considerations, available software etc, and the second covering theoretical statistical considerations.
Supported by: MRC Midland Hub for Trials Methodology Research (MHTMR), University of Birmingham
Cost: £180 per delegate (lunch and light refreshment included)
Registration: Online registration will be available shortly but for further information and to register your interest in attending then please contact Karen Biddle (Senior Administrator for MHTMR) on [log in to unmask]
You may leave the list at any time by sending the command
SIGNOFF allstat
to [log in to unmask], leaving the subject line blank.
|