From a Wall Street Journal interview (25-26 August) with Dr. Scott Gottlieb, U.S. F.D.A. Commissioner
….“You don’t have the traditional three phases of clinical trials,” he explains, “but you have one continuous trial,” enrolling more people as you go.
More broadly, the placebo trial, in which some patients receive a sugar pill or solution, is ill-suited to many situations. Sometimes there are too few patients. Sometimes there are ethical problems with putting patients through a painful placebo regimen. An alternative is to compare the drug against “natural history”—data about how patients usually fare over time without treatment. In many cases, “the decline is predictable,” Dr. Gottlieb says. “If we could develop good natural-history models in these diseases, then we wouldn’t have to rely as much on placebo.”
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