Explanatory Clinical Trial (ECT)

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An Explanatory Clinical Trial (ECT) is a Clinical Trial that is designed to test causal research hypotheses and determine the effects of an intervention under ideal circumstances.



References

2021

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Efficacy#Medicine Retrieved:2021-11-14.
    • QUOTE: In medicine, efficacy is the capacity for beneficial change (or therapeutic effect) of a given intervention (for example a drug, medical device, surgical procedure, or a public health intervention). Establishment of the efficacy of an intervention is often done relative to other available interventions, with which it will be compared. Specifically, efficacy refers to "whether a drug demonstrates a health benefit over a placebo or other intervention when tested in an ideal situation, such as a tightly controlled clinical trial." These studies focus on a primary parameter to be shown statistically different between placebo and intervention groups. Comparisons of this type are called 'explanatory' randomized controlled trials, whereas 'pragmatic' trials are used to establish the effectiveness of an intervention regarding also non-specific parameters. Effectiveness refers to "how the drug works in a real-world situation", and is "often lower than efficacy because of interactions with other medications or health conditions of the patient, sufficient dose or duration of use not prescribed by the physician or followed by the patient, or use for an off-label condition that had not been tested."

2011

Figure 1: Schematic of the relationship between explanatory and pragmatic trials. The wide base of the pyramid depicts the relatively higher proportion of explanatory trials.

2009

2003

1967