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Quality-of-life end points in cancer clinical trials: the U.S. Food and Drug Administration perspective.

Increasingly, quality-of-life (QOL) end points are being incorporated into randomized, controlled clinical trials in oncology. The Oncologic Drugs Advisory Committee (U.S. Food and Drug Administration) has recommended that beneficial effects on QOL and/or survival be the basis for approval of new anticancer drugs. Therefore, from a regulatory standpoint, for drugs that do not have an impact on survival, demonstration of a favorable effect on QOL is more important than most other traditional measures used to assess efficacy, such as objective tumor response. Trials incorporating QOL questions will be evaluated on the basis of how well they address the stated objectives. The clinical protocol should delineate investigators' hypotheses and choice of validated instruments and should specify a detailed statistical analysis plan describing strategies for handling missing data. The U.S. Food and Drug Administration welcomes the opportunity to explore with investigators the use of QOL instruments in the design of cancer clinical trials.