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

NCT02428556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2015-04-29

No results posted yet for this study

Summary

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.

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."

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428556 on ClinicalTrials.gov