HTA Agency, Poland
Effectiveness and Efficacy
As for Effectiveness and Efficacy, we do not think, that there can be problem with mistaking this two terms.
As “Efficacy” refers strictly to the trial setting it is difficult to even assume to what extent, the effects obtained in such “ideal” setting can be generalized outside to clinical practice, where the conditions as well as characteristics of treated population differs.
Although high quality, randomized clinical trials provide the most reliable evidence on the benefit of the new treatment over the standard, the Polish guidelines for conducting HTA reports suggest, that the effectiveness of the medical technology should be taken into consideration, as it reflects the effects of an intervention as measured in a situation similar or very similar to common clinical practice.