The ultimate objective of our research is the development of S+SEQSTAT: a
next generation software toolkit for the design, monitoring, and analysis
of clinical trials using group sequential methods. The software toolkit
will make fundamental contributions to the public and scientific interest
in at least three ways: 1) improved ethical and safe conduct of clinical
trials, 2) increased efficiency of conducting clinical trials, and 3)
general advancement of the use of group sequential methodology in
scientific problems involving data subject to interim analyses.
Despite the well known benefits of group sequential methods, their use in
actual clinical trials falls far short of their potential. Our research
will attempt to realize this potential by establishing the standards and
software for formal statistical use of group sequential methods in
clinical trials. We will unify group sequential methodology into a single
framework, and use this framework to develop a next generation object-
oriented software toolkit. This toolkit will be accompanied by a
graphical user interface and interactive multimedia story book of case
studies. We will also extend the routine use of group sequential methods
to problems such as unplanned interim analyses, interpretation of
secondary outcomes, and the adjustment of survival curves.
PROPOSED COMMERCIAL APPLICATION: S+SEQSTAT will result in an add-on module
to the S-Plus software system. Even a very small improvement in the
efficiency with which clinical trials are run will lead to a huge savings
in the pharmaceutical industry. Moreover, motivated by ethical concerns,
there is increasing demand of methodology to speed up the drug approval
process. S+SEQSTAT both improves the efficiency of clinical trials and
directly addresses ethical concerns.
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