Opportunities and Challenges: Assessing Quality of Life in Clinical Trials

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Quality-of-life outcomes have become important end points in oncology clinical trials (1–3) . Their popularity can be attributed to several factors, including the growing recognition that the so-called soft nature of most quality-of-life variables does not preclude valid and reliable measurement (4–7) . Perhaps the most important factor is the proliferation of therapies that has occurred over the past few decades (1) . Physicians possess a larger therapeutic arsenal for cancer than ever before. However, most available therapies are accompanied by frequent and sometimes debilitating side effects. A given treatment modality may convey greater (or equivalent) life expectancy relative to another yet lower a patient's quality of life to such an extent that the patient would have been better off had he or she undergone a different therapy. Incorporating quality-of-life assessments into clinical trials provides the opportunity to acquire a more comprehensive picture of the benefits and detriments that accrue from a given therapy, thereby increasing the likelihood of making optimal treatment decisions. However, with increased opportunities come new challenges. In this issue of the Journal, Moinpour et al. (8) present the results of a study that illustrates both the opportunities and the challenges of assessing quality-of-life outcomes in clinical trials.