An analysis of ongoing randomized clinical trials (RCTs) in diabetes finds that only about 20 percent have as primary outcomes results that patients consider important, such as illness, pain, effect on function and death, according to a new study.
Concerns about the safety and efficacy of diabetes interventions continue, in part because RCTs have not measured their effect on patient-important outcomes as quality of life and death, according to background information in the article. "Are future diabetes trials likely to be more informative to patients and clinicians?" the researchers ask.
Gunjan Y. Gandhi, M.D., M.Sc., and M. Hassan Murad, M.D., M.P.H., of Mayo Clinic, Rochester, Minn., and colleagues examined large public clinical trial registries to systematically determine the extent to which ongoing and future registered RCTs plan to measure patient-important outcomes in patients with diabetes. The researchers identified phase 2 through 4 RCTs enrolling patients with diabetes.