Efficacy vs Effectiveness
Tightly controlled trials are poor predictors of real-world outcomes
William Aryitey |
Traditional efficacy trials are not enough to guarantee that an intervention will work in the more diverse population seen in the clinic, according to researchers who evaluated the effectiveness of an inhaled drug combination for chronic obstructive pulmonary disease (COPD) in everyday clinical practice (1).
“Efficacy studies are limited in their usefulness to clinicians as they are often restricted in their inclusion criteria, meaning that they show what the drugs can do in a controlled setting but not necessarily what they can do in the real world,” says Jørgen Vestbo, first author and professor of respiratory medicine at the University of Manchester. In fact, the authors suggest that fewer than 10 percent of COPD patients would normally be eligible for efficacy trials, since they typically exclude anyone with a coexisting condition. The investigators carried out a randomized study in patients under the care of general practitioners, without the frequency, monitoring or strict eligibility criteria of a controlled trial, to allow for the variation in adherence, dosing frequency, and inhaler technique seen in unsupervised patients.
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