Trials at the Point-of-Care

A new type of clinical trial now undergoing testing at the Veterans Affairs (VA) Boston Healthcare System will likely be of interest to emerging accountable care organizations (ACOs) as well as the drug companies that court them. The new approach, most useful in comparative effectiveness research, overcomes the chief disadvantages of the two flanking options: an observational study involving non-experimental treatment decision making or a full-scale, randomized and placebo-controlled trial.

So says Stanford University biostatistician Philip Lavori, who developed the fledgling “point-of-care” clinical trial with the help of Boston clinicians and researchers. The current choices are to get a right but possibly outdated answer (think the $125 million Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial) or a cheap and fast one with some potentially unpleasant surprises (i.e. increased heart disease and breast cancer risk among women given hormone replacement therapy)...