Abstract #302054

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JSM 2002 Abstract #302054
Activity Number: 231
Type: Luncheons
Date/Time: Tuesday, August 13, 2002 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #302054
Title: Do's and Don'ts in Active Control Clinical Trials
Author(s): Mani Lakshminarayanan*+
Affiliation(s): Centocor, Inc
Address: 200 Great Valley Parkway, Malvern, Pennsylvania, 19355-1307, USA
Keywords:
Abstract:

Active controls are typically included in Phase II/III clinical trials as a reference standard for efficacy comparisons. Inclusion of active controls could help to differentiate between an 'ineffective" drug versus an "ineffective" study. There are several inherent problems with including active controls in a trial, starting from trial design to the final reporting and interpretation of results. This roundtable should include discussions on the topics that are relevant during this time span in the drug development process.

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JSM 2002

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Revised March 2002