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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 2009

Interventions

  • Other: Presentation 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.

Arms, Groups and Cohorts

  • Experimental: Directive “open question” statement
    • Survey describes the surrogate outcome of the drug along with a directive warning (i.e., stating the issue and why it matters) for drugs shown to improve surrogate outcomes. This directive warning mentions that it is not known whether the drug will help patients feel better, and that readers should ask their doctor if there is an available drug shown to improve patient outcomes.
  • Experimental: Non-directive open question statement
    • Survey describes the surrogate outcome of the drug along with a non-directive warning (i.e., stating the issue only) for drugs shown to improve surrogate outcomes. This non-directive warning mentions only that it is not known whether the drug will help patients feel better.
  • Experimental: No open question statement
    • Survey only describes the surrogate outcome of the drug.

Clinical Trial Outcome Measures

Primary Measures

  • Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes
    • Time Frame: 0 weeks (assessed during intervention)

Secondary Measures

  • 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)

Participating in This Clinical Trial

Inclusion criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • White River Junction Veterans Affairs Medical Center
  • Collaborator
    • Attorney General Consumer & Prescriber Education Grant
  • Provider of Information About this Clinical Study
    • Lisa M. Schwartz, MD, MS, White River Junction VAMC
  • Overall Official(s)
    • Lisa M Schwartz, MD, MS, Principal Investigator, White River Junction Veterans Affairs Medical Center
    • Steven Woloshin, MD, MS, Principal Investigator, White River Junction Veterans Affairs Medical Center

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