458
Participants
Start Date
June 30, 2014
Primary Completion Date
June 30, 2014
Study Completion Date
June 30, 2014
Facts only
Communicate basic information about breakthrough drugs provided in FDA press release without using Breakthrough label
promising language
"Communicate basic information about breakthrough drugs provided in FDA press release, using language commonly used by FDA in describing breakthrough drugs (promising drug)"
breakthrough only
Communicate basic information about breakthrough drugs provided in FDA press release using Breakthrough label (similar to information found in FDA press releases)
"breakthrough with may warning"
"Adding a tentative disclaimer (similar to that found on the FDA labels of some breakthrough designation drugs): Continued approval for this indication may be contingent upon verification and description of clinical trial benefit in confirmatory trials"
"breakthrough with is warning"
"Adding a more definitive disclaimer to minimize inaccurate inference from Breakthrough terminology: Continued approval for this indication is contingent upon verification and description of clinical trial benefit in confirmatory trials."
Dartmouth-Hitchcock Medical Center
OTHER