Recommendations for Procedural Sedation Clinical Trials

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We thank Butterworth1 for his editorial that accompanies our recent article2 and helps define the different processes that are used to produce published reviews that clarify and summarize difficult clinical problems. When these reviews contain recommendations and come from regulatory or accrediting agencies (eg, Food and Drug Administration [FDA], the Joint Commission) or a professional society (eg, American Society of Anesthesiologists), they may even be considered “standards” that mandate certain clinical practices. At the other extreme are recommendations by a group of “experts,” based on evidence available in the literature, to guide clinical research investigations, including clinical trials, but not to mandate clinical practice. Our recent article, along with a related systematic review,3 falls in this latter category.
After a series of questions regarding the authors’ “standing” to produce such evidence-based recommendations, Butterworth1 asks: “Alternatively, should we regard these recommendations as well-intended advice from a group of interested investigators and consultants?” We would answer this question in the affirmative. Butterworth1 also suggested that “… it would have been preferable that the authors had subjected their conclusions and recommendations to peer review by some of the relevant stakeholder societies before submitting the document for publication.” Since our conclusions and recommendations involve clinical research and not clinical care, we do not think it necessary to specifically involve “stakeholder societies.” We want to emphasize that the investigators and clinicians included in our effort were selected not only because of their expertise related to sedation research but also to ensure that multiple medical specialties were represented, including anesthesiology, pediatrics, emergency medicine, gastroenterology, dentistry, and critical care medicine. Once such a diverse group is engaged, adding additional consultations does not necessarily improve the resulting consensus opinion.4
The two stakeholders mentioned in Butterworth’s1 last paragraphs, the pharmaceutical industry and the FDA, have not been sure how best to design clinical trials for procedural sedation. Indeed, the impetus for our effort was the FDA’s expansion of the scope of the Analgesic, Anesthetic, and Addition Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public– private partnership to include procedural and intensive care unit sedation and sponsor efforts to optimize the design of sedation clinical trials. Of course, the many clinical trials needed to show efficacy will have varying objectives and there cannot be a single best way to investigate all new agents, devices, or protocols for procedural sedation. We hope that we have provided worthwhile guidance and recommendations that can be utilized when industry and academic investigators are designing clinical trials for procedural sedation and regulatory agencies are evaluating their results.
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