Management of Statistical Issues
Following are some examples of these types of issues
and the approach taken by Clinipace Biostatistics, with
the client, to address them to the regulatory authority’s
satisfaction. They are presented within the four trial
stages to highlight the services that are available at
each point: Trial Planning, Trial Conduct, Trial
Analysis, and Trial Submission.
Trial Planning
Early identification of potential issues and related
strategies can help to reduce time needed at the later
stages of the trial lifecycle and any potential delays in
achieving approval.
Based on Clinipace Biostatistics’ experience with
regulatory authorities, including the FDA, and
experience with clients, they can help to develop a new
or review an already developed protocol that considers
all potential issues in advance to save time and money
later. Based on knowledge of regulatory authorities’
expectations, Clinipace Biostatistics can help ensure
good science and the most appropriate statistical
approach based on the best study design for the study
aims. For example, although adaptive and Bayesian
study designs are currently popular, they aren’t
EXAMPLE
Protocol development for a phase
III trial after the phase I and II trials
have already been completed.
Following completion of their phase II trial,
a company needed biostatistical support
to organize and present the phase I and II
information as well as developing the protocol
for the phase III pivotal trial for a device with a
diagnostic component. Clinipace Biostatistics
assisted with organizing the information,
developing a proposed phase III protocol, and
interacting with FDA at the face-to-face meeting.
Based on feedback from the meeting, which
resulted in specific FDA requests for the design
and analysis, Clinipace Biostatistics helped
the client update and complete the protocol
to meet the regulatory requests while
maintaining an achievable sample size.
required by regulatory authorities nor are they ѡ