NCT00950157

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,944 (actual)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Risk Communication

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2009-07-31
• Last updated: 2010-06-07