Consideration of multiple chronic diseases in randomized controlled trials.

摘要

To the Editor: Before approval of a new drug, the US Food and Drug Administration (FDA) requires phase 3 clinical trials demonstrating efficacy. Usually trials are conducted in homogeneous populations and rarely include individuals with multiple chronic conditions. In the United States, more than 50% of people with chronic conditions have 2 or more diseases.1 Twenty-eight percent of the population lives with multiple chronic conditions, including 2 of 3 older individuals.2 Multiple chronic conditions account for 66% of the country's overall health expenditures2 and more than 95% of Medicare expenditures.