FDA "Breakthrough Drugs": A Trial Testing the Effect of Alternative Language on Public Perceptions

OBJECTIVE: To learn how people understand language used by the FDA to describe certain newly approved medications called "breakthrough" drugs. BACKGROUND: FDA allows drugs to be designated as breakthrough if there is preliminary evidence that it may offer a substantial improvement over available therapies. But consumers (and prescribers) may mistake the word - which in this context means very preliminary promise and lots of uncertainty - to mean the drug is proven to be much more effective or much safer than existing drugs. METHODS: Internet survey (with colleagues from Carnegie Mellon University) using Amazon Mechanical Turk - a web tool that recruits people willing to do surveys (https://www.mturk.com/mturk/welcome). Participants will be asked to read a short scenario about a new drug (facts are based on a real drug but the investigators use a fictional name) and answer questions about how well they think the drug works, how safe it is, etc. People will be randomized to one of 5 versions of the scenario differing in how explicitly they explain what "breakthrough" means. The information in the scenario is drawn from FDA's own press release about the drug.