"Reflection paper on the need for active control in 12 therapeutic areas where use of placebo is deemed ethical 13 and one or more established medicines are available"
"Where feasible, three-arm trials including experimental medicine, placebo and active control represent 24 a scientific gold-standard and there are multiple reasons to support their use in drug development. 25 However, there are situations where such trials are not required by CHMP for a properly informed 26 decision on benefit-risk. 27 It is the position of CHMP that, where ethical and feasible, a placebo control arm should be included in 28 the pivotal trial(s) used to support marketing authorisation application. The need for an active control 29 must be considered on a case-by-case basis. CHMP consider it to be particularly important for 30 estimated benefits and risks to be contextualised through comparison to active control where: 31 ?h the experimental medicine might be associated with safety concerns which impact mortality or 32 morbidity, markedly impair quality of life or cause active treatment to be discontinued or delayed 33 leading to significant, long-term or irreversible harm. 34 ?h treatment with a medicine of inferior efficacy might conceivably lead to significant, long-term or 35 irreversible harm for the patient. 36 In both scenarios, the comparison to active control will usually need to be ??direct?? (i.e. within the same 37 trial). There are few circumstances where an indirect comparison might be considered sufficiently 38 reliable. 39 This paper should not be interpreted as describing criteria used by CHMP for making a benefit-risk 40 decision. CHMP opinions are given on the basis of a benefit-risk balance in the context of a marketing 41 authorisation application. This paper outlines a framework for the discussion and justification of the 42 choice of control arms that is expected from an applicant in a marketing authorisation application."
Goes towards explaining why the "active placebo" argument is unlikely to carry any weight. It is clear that the "gold standard" for trials is to show stat signficance from placebo (baseline) to trial drug AND comparator (active control) to trial drug.
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