Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician focusses on how to go about finding and using your biostatistician.
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Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician
1. Practical Biostatistics for Clinical Trials,
or How to Find and Use Your Biostatistician
Scott Brown, Ph.D.
NAMSA
2. 2
Overview
Biostatistics Process
Finding Your Biostatistician
How Does the FDA View and Use Biostatistics?
Statistical vs. Clinical Significance
What Does FDA Expect?
3. 3
Biostatistical thinking is an integral part of
the design – not to mention analysis and
presentation – of nearly every clinical trial
4. 4
Biostatistics Process
Clinical Study
Planning
Development of
Protocol / SAP
“Operational”
statistics: tables,
listings, figures
Output: clinical
study reports,
scientific
communications
Interpret:
internal /
external consult,
regulatory,
reimbursement,
customers
6. 6
Optimal situation:
biostatistician with clinical and regulatory experience including
previous FDA submissions, collaboration with non-statisticians
including physicians, and working knowledge of disease state
and therapeutic area
11. 11
FDA’s Division of Biostatistics within the
Center for Devices and Radiological
Health (CDRH) is a section of the Office of
Surveillance and Biometrics
12. 12
Statisticians tend to work across different
therapeutic areas and may or may not
have knowledge of the specific disease
state or treatment under consideration
13. 13
Biostatistical analysis is a tool to help
interpret data, not a sole means of
reaching conclusions about approvability
The FDA statistician will not be the one signing the approval
letter
14. 14
This point cannot be overstated: FDA
evaluates “the totality of the data”
That is, hitting your primary endpoint does NOT imply FDA
approval of the application – for that matter, failing to hit your
primary endpoint does not imply disapproval
16. 16
P-values tell us nothing about the size or
relevance of an observed benefit – only
whether the benefit can be explained by
chance
For example, a large study can detect small, clinically irrelevant
differences as being statistically significant
17. 17
Conversely, a large clinical benefit can fail
to be statistically significant if the trial is
small or poorly designed
Clinical significance depends on the magnitude of the effect and
the importance of the outcome
20. 20
Statutory directive: for PMA submissions,
rely upon valid scientific evidence to
determine whether there is reasonable
assurance that the device is safe and
effective
21. 21
For a PMA (or 510(k)) submission, certain
endpoints will be prespecified in the
protocol and possibly the statistical
analysis plan (if one exists)
22. 22
To view the complete series about Practical Biostatistics for
Clinical Trials, or How to Find and Use Your Biostatistician
Visit NAMSA Seminars
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Download our brochure on Clinical Research
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