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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Czarnecki A. Monitoring of adverse events and reporting. Drug Inf J. 1995;29:307–311.
Czarnecki A. Central Register of Clinical Trials: Current status of clinical research in Poland. Drug Inf J. 1997;31:873–877.
Czarnecki A, Zalewska K. Legal documents regulating conducting clinical trials in Poland. Appl Clin Trials. 1997;6:32–34.
Good Clinical Practice for trials on medicinal products in the European Community. The rules governing medicinal products in the European Community. Vol. III, Brussels, Belgium: European Commission; 1990.
International Conference on Harmonization E2A. Definitions and Standards for Expedited Reporting. CPMP/ICH/377/95. London, United Kingdom: Committee for Proprietary Medicinal Products; 1995.
International Conference on Harmonization E3. Structure and Content of Clinical Study Reports. International Conference on Harmonization. CPMP/ ICH/137/95. London, United Kingdom: Committee for Proprietary Medicinal Products; 1995.
Westbroek J, Saavelainen S, Laher M. Oral steroid sparing effect of two doses of nebulized fluticasone propionate and placebo in patients with severe chronic asthma. Respiratory Med. 1999;93(10):689–699.
Littlejohn T III, Saini R, Kassler-Taub K, Chrysant SG, Marbury T. Long-term safety and antihypertensive efficacy of irbesartan: Pooled results of five open-label studies. Clin Experiment Hypertension. 1999;21(8): 1273–1295.
Guazzi M, Melzi G, Marenzi GC, Agostoni P. Angiotensin-Converting enzyme inhibition facilitates alveolar-capillary gas transfer and improves ventilation-perfusion coupling in patients with left ventricular dysfunction. Clin Pharmacol Therapeutics. 1999; 65(3):319–327.
Czarnecki A, Zalewska K. Regulatory control of clinical trials and the use of new drugs. Acta Physio-logica et Therapeutica Latinoamericana. 1996; (suppl), 251.
Czarnecki A, Zalewska K. National Register of Clinical Trials—A method to improve GCP compliance. Pharmacoepidemiol Drug Saf. 1998;7:423–424.
Zalewska K, Czarnecki A. Clinical Trials in Poland—Four Years of Central Register of Clinical Trials. Presented at the DIA 34th Annual Meeting, Boston, Massachusetts, June 1998.
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) doi:10.1177/009286150203600120
- Adverse events
- Clinical trials
- Number of withdrawals and deaths