Analysis of Drug Safety Data From Clinical Trials

Abstract

An analysis of combined safety data from cardiology, pulmonology, and bioequivalence studies collected at the Central Register of Clinical Trials in Poland was conducted. The number of serious adverse events, adverse events, and patient withdrawals is lower in combined data from trials than in individual published studies. In some acute and severe conditions, more adverse events are reported in placebo-treated patients than in the treatment arm.

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Correspondence to Andrzej Czarnecki.

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Czarnecki is now Senior Pharmacovigilance Consultant, World-Wide Pharmacovigilance and Epidemiology, Eli Lilly & Co. Ltd., Windlesham, United Kingdom.

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Czarnecki, A., Zalewska, K. Analysis of Drug Safety Data From Clinical Trials. Ther Innov Regul Sci 36, 157–162 (2002). https://doi.org/10.1177/009286150203600120

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Key Words

  • Adverse events
  • Clinical trials
  • Number of withdrawals and deaths