What happens when promising research fails an initial futility analysis in a clinical trial? In this case, damaging misinformation and potential loss of hope for patients with debilitating depression.
In open trials of deep brain stimulation (DBS), neurologist Helen Mayberg saw incredible results. But in clinical trials, rigid constraints set unrealistic benchmarks and St. Jude, the device maker leading the research, shut down experiments even though many patients improved once outside of the 6-month evaluation established by the trial.
“The halt of almost any clinical trial—and clearly this one—declares not a verdict but a mistrial,” writes David Dobbs.