Session: Phase II Trials
Pharmaceutical and biotechnology companies
trying to limit the cost of drug development attempt to
progress rapidly through late-phase exploratory development in
order to start Phase III "confirmatory" trials as rapidly as
possible. It is hypothesised that this results
in decisions being made about which products to progress to
large and expensive Phase III trials and decisions on how to design
these trials that are ill-informed. In fact, there is a
myriad of questions to try to address in Phase II "exploratory"
trials, including the quantification of dose-response, dose
selection, preliminary estimates of efficacy and safety to
inform the "go / no-go" decision and the design of Phase III
trials. The data generated to inform these decisions
is frequently imprecise because of the size, scope and
methodology of the prevailing exploratory development
paradigm.
Aims
- discuss the aims of late-phase exploratory
trials
- present different possible designs for this
type of trial
- introduce methodologies available to
quantitatively compare different possible designs
Oral Presentations
Click on the links below to view the presentations.
Identifying
appropriate phase II trial designs
Design choice for
small-scale phase II trials with non-inferiority (NI)
intention
TO-PARP -
CRUK/11/029 Olaparib in castration resistant prostate cancer
adaptive phase II design
A Bayesian
dose-finding procedure applied to a seamless Phase I/II trial in
rheumatoid arthritis