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

NACompletedINTERVENTIONAL
Enrollment

458

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Prescription Drugs
Interventions
OTHER

Facts only

Communicate basic information about breakthrough drugs provided in FDA press release without using Breakthrough label

OTHER

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)"

OTHER

breakthrough only

Communicate basic information about breakthrough drugs provided in FDA press release using Breakthrough label (similar to information found in FDA press releases)

OTHER

"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"

OTHER

"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."

All Listed Sponsors
lead

Dartmouth-Hitchcock Medical Center

OTHER

NCT02428556 - "FDA Breakthrough Drugs: A Trial Testing the Effect of Alternative Language on Public Perceptions" | Biotech Hunter | Biotech Hunter