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Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00950157
Enrollment
2944
Registered
2009-07-31
Start date
2009-08-31
Completion date
2009-09-30
Last updated
2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Communication

Brief summary

The purpose of this study is to test whether cautions about the evidence, in this case an open questions statement, decreases enthusiasm for drugs that are approved on surrogate outcomes (compared to patient outcomes) alone.

Interventions

OTHERPresentation of information on approval based on a surrogate outcome and levels of caution

Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question) statements: no open question statement, non-directive open question statement or directive open question statement.

Sponsors

Attorney General Consumer & Prescriber Education Grant
CollaboratorOTHER
White River Junction Veterans Affairs Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Design outcomes

Primary

MeasureTime frame
Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes0 weeks (assessed during intervention)

Secondary

MeasureTime frame
Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes0 weeks (assessed during intervention)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026