MedTrace Logo

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

NCT00950157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2944

Last updated 2010-06-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Attorney General Consumer & Prescriber Education Grant

    collaborator OTHER

  • White River Junction Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Lisa M Schwartz, MD, MS · White River Junction Veterans Affairs Medical Center

  • Steven Woloshin, MD, MS · White River Junction Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-08-31
Completion
2009-09-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950157 on ClinicalTrials.gov