Clinical trials are often carried out in a sequential fashion, for
reason of ethics, efficiency and costs. At the end of a sequential
trial, results such as response rate of a treatment, side effects
important clinical endpoints are often reported. But because of
sequential nature of a sequential trial, conventional methods of
presenting estimates are invalid. Currently, the methods that are
available to answer to this need are either difficult to apply or
questionable qualities. This has led to the slow acceptance of
methods in the reporting of results in sequential studies.
The primary goal of this proposal is to define, in a quantitative
succinct way, practical methods of presenting parameter estimates
sequential clinical study. The fundamental theoretical basis of
proposal is that the characteristics of the observed data in a
be studied through random samples drawn from the observed data.
Therefore, any inadequacies of using conventional estimation
be reflected and can be corrected. The specific aim of the
to study the behavior of this method in the context of giving point
interval estimates in sequential trials. The small sample
this method will be studied through simulations and the large
properties of this method will be studied through theoretical
The application of this method to group sequential trials will be
explored, with special emphasis on tissues such as non-uniform
and times of testing. The use of this method in multiple
in the case of interim analysis will be investigated. Finally, the
method will be applied to studies at Memorial Sloan-Kettering
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