The most notable nugget from the Center for Business Intelligence’s (CBI) Arlington, Virginia meeting on patient-reported outcome (PRO) research late last month was not so much from the podium, though there was plenty of excellent material there. Some of the most interesting news was in the questions from attendees. Your correspondent, for example, had assumed that utterances by regulators about PRO data have been lucid enough to assuage the doubts of the sponsor community. Wrong. From audience comments at the conference, there remains considerable ambiguity, even frustration, about the FDA stance on PRO data. Some of it seems linked to the industry’s usual torpid approach to using any new-ish technique or tool. But some of it is linked to the agency itself flashing a warning light on PRO studies. Perhaps the rumored publication (later this year or early next, or by 2019 at the latest) of a new final PRO guidance…more...