Conclusion
During clinical trials that require regulatory review and approval, planning in advance helps to avoid issues
during study conduct and lengthy regulatory reviews later. However, because no trial goes perfectly as planned,
it is important to handle any issues during trial execution and the regulatory submission in a way that creates
minimal additional regulatory scrutiny. Clinipace, including the Biostatistics team, has the expertise and
technological resources to assist with this process and help the process go as smoothly as possible.
During the companion webcast for this eBook, we received several great questions during the Q&A Session.
To read the responses, please visit each of the links in the boxes below:
Q
When planning for the
end of phase II analyses,
is there a way to get
questions about data
analyses answered by
someone at the FDA?
Q
Can you discuss
further key “operational
biases” to avoid?
Q
What is the best
way to present
post hoc analyses
to the FDA?
Q
Q
Can you briefly
highlight statistical
considerations for
adaptive trial designs?
Q
Should we choose different
alpha spending functions
in the interim analysis
with the purpose of futility
assessment versus
efficacy assessment?
Q
Will you please list
some common
protocol deviations?
Q
If you perform an interim
futility analysis, will it
impact the Type I error
if you don’t consider
stopping for superiority?
A blinded study is running. Based on monitoring
of blinded data, additional new analysis not in
SAP will be interesting. Please comment if one
should revise the SAP and provide rationale to
the FDA for change prior to study end or do as
post hoc analysis.
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