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

Risk Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950157
• Other study ID #: 16785
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: June 4, 2010
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: White River Junction VAMC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2944
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Risk Communication

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction VAMC	Attorney General Consumer & Prescriber Education Grant

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes		0 weeks (assessed during intervention)	No
Secondary	Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes		0 weeks (assessed during intervention)	No