OBJECTIVES: To determine how often SF-36 Health Survey measures respond to efficacious pharmaceutical treatment benefits in well-controlled clinical trials. METHODS: We conducted a systematic review of randomized, double-blind, placebo-controlled trials published in 124 journals in 1995 through 2009 documenting differences between treatment groups for primary medical endpoints and any of the SF-36 component summaries, or eight subscale scores.  Concordance was defined in terms of agreement between primary clinical and SF-36 endpoints (both statistically significant or both non-significant). RESULTS: A review of 2,020 identified clinical trials using the SF-36 confirmed that 162 met study design criteria. For 133 of 162 trials (82.1%), results for primary clinical endpoints and SF-36 measures were concordant.  Among the 107 trials achieving medical efficacy (primary endpoint), changes in one or more SF-36 measures were also significant, as hypothesized, for 88 (82.2%).  Similar patterns were observed by therapeutic area; for example: rheumatology (29 of 30), neurology (16 of 25), cardiovascular (15 of 18), pulmonary (11 of 13), psychiatry (8 of 10), endocrine (7 of 9), and combined surgical specialties (9 of 9) studies demonstrated concordance. In addition to evaluating characteristics of published reports and scoring methods (subscales, summaries, utility scoring) this presentation will comment on priorities for future studies of patient-reported outcomes (PROs) in evaluations of pharmaceutical and other medical treatments.   CONCLUSIONS: In support of their validity as PROs, changes in SF-36 measurements agree with primary endpoints in over 8 out of 10 well-controlled trials of pharmaceutical therapies published to date. In support of pharmaceuticals’ efficacy, when a therapy positively impacted clinical endpoints, it also improved health related quality of life quality of life in over 8 out of 10 clinical trials published to date.