[Skip to Content]
[Skip to Content Landing]
November 25, 2009

Therapeutic Innovations, Diminishing Returns, and Control Rate Preservation

Author Affiliations

Author Affiliations: Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.

JAMA. 2009;302(20):2254-2256. doi:10.1001/jama.2009.1679

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.