In the last century the use of two terms were agreed, efficacy and effectiveness,
to name two different types of assessment [
[1]
]. Efficacy assesses the performance of interventions used in controlled, ideal conditions;
effectiveness evaluates interventions in routine care conditions [
[1]
,
[2]
]. This applies to all trials, regardless the type of assessed interventions. When
referring to the development of new regulated interventions (medicines, devices) all
prelicensing trials (phases 1 to 3) assess efficacy: current clinical trials regulations
and the design, conduct (highly controlled conditions) and nature and extent of data
to be gathered to gain regulatory approval make it almost impossible to assess effectiveness.
However, in post-marketing phase 4 trials, investigators could assess efficacy or
effectiveness depending on their closeness to routine clinical care conditions. In
this type of trial, a pragmatic approach leads to obtaining effectiveness data.Keywords
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Article info
Publication history
Published online: May 02, 2018
Accepted:
April 26,
2018
Received:
April 20,
2018
Identification
Copyright
© 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
