Are MI Trial Results Generalizable to Typical Patients?
(HealthDay News) — Low levels of enrollment and more favorable risk profiles for participants raise questions about whether the findings of clinical trials are generalizable to typical patients with myocardial infarction (MI), according to research published in the August 27 issue of the Journal of the American Medical Association.
Jacob A. Udell, MD, MPH, of the University of Toronto, and colleagues analyzed data from the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines to assess whether participants in cardiovascular clinical trials are representative of contemporary patients with MI.
The researchers found that among 141,135 registry participants, 2.8% were clinical trial participants. Among trial nonparticipants, 68.0% were eligible and 32.0% were ineligible. Compared with nonparticipants, trial participants had more favorable risk profiles, including younger age, less previous cardiovascular disease, lower predicted risk of mortality, shorter hospital stays, and more frequent treatment with evidence-based therapy. In-hospital mortality was lowest for trial participants (1.5%), higher for eligible nonparticipants (2.5%; adjusted odds ratio [aOR], 1.63; P=0.01), and highest for ineligible nonparticipants (8.4%; aOR, 1.91; P=0.001).
"Efforts to improve trial participation are needed to enhance generalizability of results," the authors write.
The national registry provided data and funded the study. Several authors and the national registry disclosed financial ties to the pharmaceutical and biomedical industries.