Course: Design of Phase II and Phase III trials
20-21st November Sheffield UK
Apologies for cross-posting
Speakers
Professor D Machin
Professor MJ Campbell
Authors of 'Statistical Tables for the Design on Clinical Studies',
1997, Blackwell
Further details and registration form from [log in to unmask]
Phase II Trials
These (usually non-randomised) trials are conducted to provide a
preliminary indication of the potential activity of a new drug or
other therapeutic modality. The aim of the course will be to review
some of the practical considerations when designing, conducting,
analysing and reporting Phase II trials. This will also focus on the
definition of appropriate efficacy endpoints and the impact of
treatment related toxicity. Comparisons of the (many) alternative
designs for Phase II trials – specifically discussion of the Gehan,
Fleming, Simon and Tan designs will be included. How the results
observed impact on subsequent Phase III trials will also be
indicated.
The intention is to illustrate these points with real examples taken
from the literature and from direct experience of the course faculty.
Phase III Trials
These are generally major trials that are aimed at conclusively
demonstrating efficacy. The course will briefly review the reasons
why these trials should be randomised, comparative with placebo or
standard treatment, and why some degree of ‘blinding’ is desirable.
Alternative designs will be reviewed including parallel group,
factorial, crossover and cluster. Methods of calculating sample size
will be discussed and practical considerations when designing,
conducting, analysing and reporting these trials will be reviewed.
Examples of the difficulties posed by trials that are too small or
have prematurely closed will be given. New developments in trial
design including the impact of Bayesian approaches will be
included.
The intention is to illustrate these points with real examples taken
from the literature and from direct experience of the course faculty.
Mike
Professor Mike Campbell
Institute of Primary Care and General Practice
University of Sheffield
Community Sciences Centre
Northern General Hospital
Sheffield S5 7AU
Tel 0114 271 5919
Fax 0114 242 2136
e-mail [log in to unmask]
http://www.shef.ac.uk/michaelcampbell/
http://www.shef.ac.uk/medical-statistics/
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