An Industry Survey on Current Practices in the Design and Analysis of Active Control Studies

Christy Chuang-Stein Statistical Research and Consulting Center, Ann Arbor Laboratories, Pfizer Inc., Ann Arbor, Michigan, USA; Statistical Research and Consulting Center, Ann Arbor Laboratories, Pfizer Inc., 2800 Plymouth Road, Ann Arbor, MI, 48105, USACorrespondence[email protected]

Corsee Sanders Biometrics and Development Services, Genentech Inc., South San Francisco, California, USA

Steve Snapinn# Biostatistics and Research Decision Sciences, Merck Research Labs, Blue Bell, Pennsylvania, USA

References

CPMP/EWP/482/99. Points to Consider on Switching Between Superiority and Non-inferiority (Adopted July 2000). Available at: www.emea.eu.int/htms/human/ewp/ewpptc.htm
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ICH E10 – Choice of Control Group and Related Issues in Clinical Trials. Recommended for adoption at Step 4 of the ICH process on 20 July 2000. Available at: www.ich.org/
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#Current address: Global Biostatistics and Epidemiology, Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
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