As I read a recently published report of an interesting and important placebo-controlled trial of arthroscopic shoulder surgery, one sentence in particular caught my eye: “The study was designed under the ethical supervision of an academic ethicist (JS) with placebo trial experience.” I regularly read scientific reports of clinical trials in the medical literature, and I have never seen a sentence like this before. What does it mean? What does it imply or suggest?
Before taking up a critical examination of this unusual sentence and what it implies about the role of bioethicists, I want to make a caveat. I will not be raising any questions about the ethics of this randomized trial, which employed a sham procedure to afford a rigorous evaluation of the shoulder surgery.
One way to approach the meaning of the sentence regarding “ethical supervision” is to reflect on the role of statisticians in clinical trials. Statisticians routinely serve as collaborators with clinical investigators and often as coauthors. They are charged with such tasks as determining the sample size of a randomized trial that is sufficient to provide an adequate test of the study hypothesis, identifying the appropriate statistical tests to measure study outcomes, and assuring the accuracy of the data presented from a statistical perspective. Scientific reports of studies never contain statements such as, “The study was designed and reported under the statistical supervision of an academic statistician (AB) with experience with placebo-controlled trials.” There is no need for such a sentence. The description of study methods, which typically includes a section under the title “Statistical Analysis,” and the presentation of results should be sufficiently transparent, so that readers interested in a critical evaluation of the study statistics are provided with all the information they need. Similarly, there is no need to include a statement about the study being designed under the “ethical supervision” of an ethicist. The description of the study with respect to its ethically relevant features should be sufficiently transparent to afford ethical evaluation of its design.
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