Phase II Clinical Trial Designs - Frequentist, Bayesian and
Decision-theoretic
2 days 13-14 March
Location Reading, UK
Presenters Nigel Stallard and John Whitehead
Cost (6 weeks or more before start of course)
Student £360
Public sector/academic £450
Other £510
(less than 6 weeks before start of course
All participants £600
The nature of phase II clinical trials varies considerably between
different therapeutic areas and different research institutions. Designs
range from small-scale dose-finding studies to studies very similar to a
pivotal phase III study. One or more experimental treatments can be
evaluated and a control treatment may be included. Attention may focus on
efficacy, safety or both. This course considers three types of phase II
trials: single-arm pilot studies with all patients receiving the same
treatment, comparative studies comparing a control treatment with a single
experimental treatment, and screening studies comparing two or more
experimental treatments or doses and perhaps a control treatment.
In each case frequentist, Bayesian and decision-theoretic approaches will
be considered. The frequentist approach controls error rates, and is akin
to that used in phase III trials. The Bayesian approach incorporates prior
information updated by data as they accumulate. The decision-theoretic
approach formally considers the current trial as part of the clinical
development process, modelling the consequences of design and analysis
decisions.
Programme
* The role of phase II trials in the drug development
programme
* Review of frequentist, Bayesian and decision-theoretic
approaches to statistical inference
* Single treatment pilot studies
* Comparative phase II studies
* Selection screens
* Multiple endpoints
* Combined phase II/III trials
For further details please contact:
Barbara Dodds
MPS Research Unit
The University of Reading
PO Box 240 Earley Gate
Reading RG6 6FN
UK
Tel: + 44 (0) 118 931 6662
Fax: + 44 (0) 118 975 3169
e-mail: [log in to unmask]
|