Clinical study reports are written to compile data from clinical
trials. A CSR can be 1500 pages long, but dont be intimidated. It has 3 data sections: demographics, efficacy, safety. All the rest of the CSR is supporting data to prove the 3 data sections. GSK posted some CSRs because they were accused of conspiracy. These are our textbooks for CSRs.
The FDA needs to know about every patient who took any amount
of drug, every patient who enrolled in the trial. The ICH E3 was
compiled by a committee as a guideline of how to prepare a clinical
study report. It was published in 1996 and is still the reference
guideline. Some drug companies use this guideline as a template.
The essay by Dr Stephen de Looze was written after he served on the
ICH3 committee. He is a very senior medical writing director at
Sanofi-Aventis in Germany. He is British, went to Germany to do a PhD
in insect biology. He lives in Frankfurt with his family.
Examine the CSRs on Paxil.TM Note how the adverse event language and analysis has
been incorporated into the safety section of the CSR. Examine the efficacy
section to see how efficacy (effectiveness) is analyzed.
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