Testing the Effect of a Warning About New Drugs

White River Junction Veterans Affairs Medical Center

Status: Completed

Conditions: Risk Communication

Treatments: Other: Presentation of information about drug approval and level of warning

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00950131

16784

Details and patient eligibility

About

The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.

Enrollment: 2,944 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Trial design

2,944 participants in 3 patient groups

Directive new drug warning

Experimental group

Description:

Survey contains information about when the drug was approved by the FDA (2009)and a directive warning (i.e., stating the issue and why it matters) for new drugs. This directive warning mentions that serious drug side effects may emerge only after the drug is already on the market, and the reader should ask their doctor there is an available drug with a longer track record.

Treatment:

Other: Presentation of information about drug approval and level of warning

Non-directive new drug warning

Experimental group

Description:

Survey contains information about when the drug was approved by the FDA (2009) and a non-directive warning (i.e., just stating the issue) for new drugs. This non-directive warning mentions only that serious drug side effects may emerge only after the drug is already on the market.

Treatment:

Other: Presentation of information about drug approval and level of warning

No new drug warning

Experimental group

Description:

Survey contains information about when the drug was approved by the FDA (2009) only.

Treatment:

Other: Presentation of information about drug approval and level of warning