Clinical trials must cope better with multiplicity

Nature: November 7, 2012


Clinical trials typically address more than one question. But in attempting to protect against misleading results that are due to chance when multiple interrelated tests are run simultaneously, researchers sometimes apply overly strict statistical devices that mask true effects. They should give more consideration to choosing the type of statistical analysis that fits best.

After pouring millions of dollars into developing a drug, researchers want to learn not only whether a drug works but what the magnitude of its effect is, what clinical outcomes it affects and who should receive it. Thus they ask many questions of data collected in clinical studies. However, these interwoven questions can present a challenge when it is time for the statistical analysis of the trial’s results. With the increasing complexities of clinical trials, scientists need to be more thoughtful when it comes to choosing how they crunch the numbers. Biomedical researchers do not always choose the statistical constructs that suit their studies best, and as a result the studies they publish might miss real effects from the interventions under investigation. Read more