Journal article
A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials
Abstract
Background In early phase oncology trials, novel targeted therapies are increasingly being tested in combination with traditional agents creating greater potential for enhanced and new toxicities. When a patient experiences a serious adverse event (SAE), investigators must determine whether the event is attributable to the investigational drug or not. This study seeks to understand the clinical reasoning, tools used and challenges faced by the …
Authors
Mukherjee SD; Coombes ME; Levine M; Cosby J; Kowaleski B; Arnold A
Journal
Investigational New Drugs, Vol. 29, No. 5, pp. 1013–1020
Publisher
Springer Nature
Publication Date
October 2011
DOI
10.1007/s10637-010-9456-9
ISSN
0167-6997