It’s not exactly a news flash that there are major problems with paper patient diaries in clinical trials. Let’s just take two massively important problems: Patients don’t fill out paper diaries when they say they do. And there’s no need to puzzle out something scrawled in another language, because the electronic systems can automatically present the answers in whatever language you prefer. And yet paper diaries remain popular in clinical trials. To assess why, the organizers of the recent Drug Information Association (DIA) conference presented a debate with a ponderous title. “The Pros and Cons of ePROs: Resolved that Electronic Technology Should Be Used To Capture Patient-Reported Outcome (PRO) Data In All Clinical Trials In Which PROs Are Captured.” There were a few comments from Laurie Burke, director of the study endpoints and labeling developing team in the Office of New Drugs at FDA. Unofficially, she’s the czar of e-diaries. Speaking…more...