A slide presentation by Branching tests in clinical trials with multiple objectives is helpful in understanding the gatekeeping procedure.The website maintained by Alex Dmitrienko et al contains a lot of useful information about the gatekeeping procedures.In this way, the alpha-level for primary efficacy endpoints will be tested at alpha=0.05 level and not be compromised due to the consideration of the secondary endpoints. It is very typical that the secondary endpoints will only be tested only if the primary endpoint is tested significantly. While the term ‘gatekeeping procedure’ may not used, this approach has been implemented in many clinical trials, especially in the regulatory setting. In other words, the families of hypotheses examined earlier serve as gatekeepers. With gatekeeping procedure, the families are tested in a sequential manner and the tests for subsequent families will be performed only if the tests for the previous family is significant. If there are many secondary endpoints, the secondary endpoints can be further divided into multiple secondary different families.
EVAN MILLER SEQUENTIAL TESTING TRIAL
For example, a clinical trial will typically have one or more primary endpoints (family for primary endpoints) and have multiple secondary endpoints (family for secondary endpoints). Gatekeeping Procedure is used in the situation when there are multiple endpoints and these multiple endpoints are grouped into different families.
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