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Clinically significant adverse effects in a Phase 1 testing program
Author(s) -
Zarafonetis Chris J. D.,
Riley Philip A.,
Willis Park W.,
Power Lawrence H.,
Werbelow Judson,
Farhat Leo,
Beckwith Wendall,
Marks Bernard H.
Publication year - 1978
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1978242127
Subject(s) - medicine , adverse effect , placebo , complication , drug , surgery , pharmacology , alternative medicine , pathology
Twelve years' experience with a Phase I drug testing program in normal prison volunteers is reported. lnvolved in 805 protocol studies were 29,162 participants over 614,534 subject days. During this period there were 64 significant medical events ofwhich 58 were adverse drug reactions and 6 were complications. One subject has residual hip changes due to an infectious complication, another on placebo died from cerebrovascular hemorrhage while asleep. There was complete recovery from all adverse drug reactions and the other 4 complications encountered. Thus a clinically significant medical event occurred once every 9,602 days ofsubject exposure or about once every 26.3 years of individual subjeet participation.