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.
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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