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Everything needs to related to an actual BREAST CANCER study. An actual one.
The trial was conducted and concluded, and you gathered the data in the database (actually you
didn’t, it was gathered for you from another trial).
Efficacy and safety data were gathered. Some of the numeric data (like "age") can be
compared between groups by using a simple "t-test" (see the Statistics Slide
presentation regarding how to perform your own t-test using a web statistics calculator). For those
data that can’t be compared using a t-test (AEs, for example), one would make an AE table (not
unlike those AE tables you have already seen in the published reports you have read earlier),
comparing AEs between two treatment groups. The published reports you read have given you
many ideas on how to present your data. All of the published reports regarding drug studies which
you read generally follow the same methodology: Title, abstract, background, methods
(demographics, assessments, etc), results, discussion. In a CSR, you are doing the same.
The CSR shell is the actual ICH shell found in the ICH guidance document and used by ALL Sponsors
who hope to complete an NDA for their drug and, perhaps, gain FDA approval.
When you conduct your analyses, you will see if:
1. there is a difference between groups in your efficacy points, and
2. see if there is any difference in safety (AEs)
You will report your findings in this CSR. Note: you are only completing part of the CSR. As you can
see, the regulatory agencies want all of the information (Sections 16.1 and higher) behind the
development of your protocol, the ethics, listings of all data, etc. You will not, of course, supply
these Sections
you will take the data found in the excel spreadsheet ("Major Project 2 Database"),
analyze it, and complete a clinical study report (using the "CSR Shell ""? major
project 2") referencing your results.
The Protocol you are completing does require statistics sections which simply ask how you are going
to analyze with the data. The Excel sheet tells you what you will do with each endpoint (make %
comparisons or listings, OR, perform a t-test to detect significant differences). The Stat section in
the Protocol simply needs to state what you plan to do in the analyses. You do not have to
perform the analyses now, as that is part of Major Project 2, which is due at the end of the
semester.
So, here is a suggestion: Take a good look at the Excel sheet and determine if you are comfortable
performing the stat tasks required. Go to the Stat Slide Set available in the zipped folder. Read
through the slide set and the section "Working on your CSR II"
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