UNLABELLED: A DEVELOPING CONTROVERSY: The marketing authorization for new drugs from the regulatory authorities'and ethical point of view, is only possible following convincing proof of their efficacy and safety. Between the drug registration authorities, who underline the necessity of early assessment against a placebo, on the one hand, and the ethical and consumer committees that disapprove of the use, the controversy has developed. FOR METHODOLOGISTS: Comparisons with reference drugs provide less credible results that comparisons versus a placebo. This is why their exclusive use may have deleterious effects on the reliable assessment of products to be launched on the market, in terms of efficacy and safety. Equivalence trials do not provide the expected solution since their internal validation requires a placebo arm. RETICENCE BUT NO PROHIBITION: The fifth revision of the declaration of Helsinki by the World medical association in the year 2000, which led to violent controversy regarding the drawing-up of section 29 and its clarification note, does not really help the debate progress: the authors of the texts confirm their reticence to the use of a placebo, but do not prohibit it. They have chosen a "middle of the road" solution.IN PRACTICE: The decision to conduct or not a placebo-controlled study should take into account the aims of the study (within the context or not of a marketing authorization submittal by an industrial), the early stage of the development of the drug or not and, above all, the level of efficacy and safety of the drugs already available versus the anticipated effects of the new product.
Clinical Trials as Topic Ethics, Clinical