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Quality of life as an endpoint in Phase I oncology clinical trials of novel chemotherapy drugs

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.