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OpenTrials
Completed

NCT Number: NCT00950157

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

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.

Completed

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Key information

Conditions

Risk Communication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes

    Time frame: 0 weeks (assessed during intervention)

Secondary outcomes

  1. Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes

    Time frame: 0 weeks (assessed during intervention)

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Collaborators

  • Attorney General Consumer & Prescriber Education Grant

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 31, 2009
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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