PharmPK Discussion - Efficacy results population

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On 21 Dec 2004 at 09:33:28, "Avgoustakis Konstantinos" (avgoust.-at-.upatras.gr) sent the message


The following message was posted to: PharmPK

Dear All,
On a clinical trial for the comparison of different formulations of the
same active compound (drug) the conclusions with regard to differences
in
efficacy should be based on the results obtained with the whole
population
(intend to treat population) or on the results obtained with the
responders (patients responded to the drug) only? What happens if the
conclusions that can be drawn, based on the statistical analysis of the
results, differ between these two populations? Your advice would be
greatly appreciated.
Thank you
K. Avgoustakis, PhD
Department of Pharmacy
University of Patras
Greece

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On 21 Dec 2004 at 16:33:06, dengcq.aaa.netscape.net sent the message


The following message was posted to: PharmPK

Dr. Avgoustakis,

I am assuming you are talking about a randomized trial. For a
randomized trial, it is typical to use Intention-to-treat population
for your efficacy analysis. Then you can do a sensitivity analysis on
other populations (such as patients responded to the drug,
per-protocol, or completers,...). The evidence on the difference of
efficacy results will be questionable if you draw the difference
conclusions from the primary analysis and the sensitivity analysis.
Hopefully, this will not happen.

Thanks,
CQ Deng, PhD
PPD Development
Research Triangle Park, North Carolina
USA

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