Author Affiliations: Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.
Acceptance of therapeutic innovations into practice requires demonstrating and quantifying a treatment effect, measured as the difference in outcome rates between experimental and control groups of a randomized trial. This mathematical dependency of the treatment effect on the control event rate (ie, the rate of events in the control group) creates a dilemma for medical innovation. Although decreasing control rates signal therapeutic progress, sustained innovation theoretically requires an inexhaustible control rate. For industries dependent on therapeutic innovations, reducing outcome rates becomes both a primary goal and an existential threat.
Kent DM, Trikalinos TA. Therapeutic Innovations, Diminishing Returns, and Control Rate Preservation. JAMA. 2009;302(20):2254-2256. doi:10.1001/jama.2009.1679