title: Quality of life as an endpoint in Phase I oncology clinical trials of novel chemotherapy drugs.
abstract: This paper examines the rationale, utility and feasibility of including quality of life as an outcome measure in Phase I trials of new applications of chemotherapy drugs. Typically, Phase I trials in oncology are designed to assess safety and maximal tolerated dose; however, it is argued that when subjectively assessed, self perceived quality of life is as important as physical toxicity. The outcomes of studies that have applied quality-of-life assessment in Phase I trials are reviewed, and recommendations are made for future research based on both methodologic and practical considerations.
authors.affiliation: University of Calgary, Department of Psychosocial Resources, ACB Holy Cross Site, 2202 2nd St., SW Calgary, Alberta, T2S 3C1, Canada. l.carlson@ucalgary.ca
authors.forename: Linda E
authors.initials: LE
authors.lastname: Carlson
authors.forename: Sheila
authors.initials: S
authors.lastname: Garland