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In contrast to the ICH-E14 stipulated methodology, this study was not placebo-controlled or double-blinded, nor did it use an active control for the assessment of assay sensitivity 30, 35.
"If it's easier to do the trial if you use an active control rather than a placebo, then fine, do the trial that way," Smith says.
To control this in future, it would be recommended to use an "active" control group, in that controls are asked to do for example online games at the computer.
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If, however, an effective standard treatment exists, then a conventional randomized controlled trial using an active control could be ethical, but the circumstances of a pandemic might make it impossible, as I will show.
The new RFX load assembly characterized by a thin copper shell requires using an active control system for the plasma equilibrium.
In this work, a method is proposed which uses an active control scheme to manipulate the acoustic boundary conditions of the test rig.
But at the meeting, Ripley Ballou from GlaxoSmithKline (GSK), which has the Ebola vaccine furthest in development, won wide support for his argument that the fastest, most ethical way to assess whether the product works is with an RCT that uses an "active control"—such as a proven vaccine against an unrelated disease rather than a dummy placebo shot.
Only one study [ 48] used an active control group, in comparison with an inactive control group.
This result must be interpreted very cautiously because only a few studies used an active control group [ 20, 23, 40].
Another reason for using an active control is that it would not be ethically sound to withhold smokers with airflow limitation from smoking cessation treatment.
Because this project uses an active control we are essentially looking at the cost-effectiveness of receiving BPT rather than Pilates.
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CEO of Professional Science Editing for Scientists @ prosciediting.com