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

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ClinicalTrials.gov Identifier: NCT02428556
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Prescription Drugs Other: Facts only Other: promising language Other: breakthrough only Other: breakthrough with "may" warning Other: breakthrough with "is" warning Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: FDA "Breakthrough Drugs": A Randomized Trial Testing the Effect of Alternative Language on Public Perceptions
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Active Comparator: Facts only
Scenario describes study results without "breakthrough" language, "promising" language, no cautions about conditional approval
Other: Facts only
Communicate basic information about breakthrough drugs provided in FDA press release without using Breakthrough label

Active Comparator: promising language
study description describes drug as "promising"; no warning about conditional approval
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")

Active Comparator: breakthrough with "may" warning
study describes drug as "breakthrough"; warning that continued approval may be contingent on subsequent verification of clinical benefit in confirmatory trials
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"

Active Comparator: breakthrough with "is" warning
study describes drug as "breakthrough"; warning that continued approval may be contingent on subsequent verification of clinical 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."

Experimental: breakthrough only
Scenario describes study results with "breakthrough" language, no cautions about conditional approval
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)




Primary Outcome Measures :
  1. effectiveness of zykanta [ Time Frame: within 1 day ]

    After reading description of a trial for a hypothetical drug, participants will be asked:

    How effective do you / think Zykanta is at treating metastatic lung / cancer? Response will be choice of one of the following Not at all effective Somewhat effective Very effective Completely effective



Secondary Outcome Measures :
  1. effect on tumor [ Time Frame: within 1 day ]

    If a patient with / metastatic lung cancer started to take Zykanta, what do you think / would happen to their tumor over the next 6 / months

    Choices:

    • Nothing
    • Shrink a little
    • Shrink a lot
    • Go away completely

  2. strength of scientific evidence [ Time Frame: within 1 day ]

    How strong is the scientific / evidence that Zykanta helps patients with metastatic lung / cancer?

    Choices

    • Extremely weak
    • Weak
    • Strong
    • Extremely strong

  3. Interest in taking [ Time Frame: within 1 day ]

    If a close friend or / family member was diagnosed with metastatic lung cancer, / would you want them to take / Zykanta?

    Choices

    • Definitely not
    • probably not
    • probably yes
    • definitely yes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

english speaking adult

Exclusion Criteria:


Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02428556     History of Changes
Other Study ID Numbers: STUDY00028203
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:
Decision making