Adaptive and Group Sequential Designs
|
Monday 7 December 2009 |
| Led by: |
Professor Chris Jennison
Medical Statistician
University of Bath |
| The workshop will introduce adaptive and group sequential methods for Phase II and Phase III clinical trials, with examples and opportunity for discussion of participants' own problems. |
| About the workshop: |
The workshop will introduce adaptive designs which make it possible to modify a clinical trial in mid-course. In Phase II, treatment allocation rules can be based on the emerging shape of the dose-response curve. In Phase III, it is possible to modify design while preserving the type I error rate. Factors that can be changed include: sample size, treatment definition, primary endpoint, patient population, and the null hypothesis of superiority or non-inferiority. Topics will be illustrated by examples and discussion of problems posed by the participants. |
Workshop agenda |
| 09:30 |
Registration and coffee |
| 10:00 |
Introduction and motivation |
| 10:15 |
Combination tests |
| 10:30 |
Sample size modification for a nuisance parameter |
| 10:45 |
Rescuing an under-powered study |
| 11:00 |
The role of group sequential tests |
| 11:45 |
Switching from testing for superiority to non-inferiority |
| 12:00 |
Open discussion of examples and problems |
| |
|
| 12:30 |
Lunch |
| |
|
| 1:30 |
Testing multiple hypotheses |
| 2:00 |
Mid-study changes to treatment or endpoint |
| 2:30 |
Enrichment: switching focus to a sub-population |
| |
|
| 3:00 |
Break |
| |
|
| 3:30 |
Adaptive dose allocation in Phase II trials |
| 4:00 |
Combining data from Phases II and III |
| 4:15 |
Seamless Phase II/ Phase III trials: benefits vs logistics |
| 4:30 |
Case studies and discussion |
| |
|
| 5:00 |
Close of workshop |
| |
|
| About your workshop leader |
Christopher Jennison is Professor of Statistics and Dean of the Faculty of Science at the University of Bath, UK. He was awarded his PhD from Cornell University for research into the sequential analysis of clinical trials and he has continued to work in this area for the past 25 years. He has written widely, particularly with Professor Bruce Turnbull, on group sequential methods and adaptive designs for clinical trials and their 2000 book "Group Sequential Tests with Applications to Clinical Trials" remains a key reference in this area. |
| About your workshop company |
MAASTRO, Maastricht Radiation Oncology, is a co-operation between MAASTRO clinic, the University of Maastricht (UM) and the University Hospital Maastricht (azM). The medical physics department of MAASTRO provides physics and technical support for MAASTRO Clinic, which offers state-of-the-art radiotherapy to more than 3000 cancer patients each year from the Limburg area in the Netherlands. MAASTRO clinic currently has 7 modern linear accelerators. A strategic highlight of MAASTRO is Computer Aided Theragnostics (CAT).
See www.maastro.com for more details. |