Testing the Effect of a Warning About New Drugs | NCT00950131 | Trialant

Testing the Effect of a Warning About New Drugs | NCT00950131 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Directive new drug warning	Experimental	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.	Other: Presentation of information about drug approval and level of warning
Non-directive new drug warning	Experimental	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.	Other: Presentation of information about drug approval and level of warning
No new drug warning	Experimental	Survey contains information about when the drug was approved by the FDA (2009) only.	Other: Presentation of information about drug approval and level of warning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Presentation of information about drug approval and level of warning	Other	Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning

Outcomes Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Lisa M Schwartz, MD, MS	White River Junction Veterans Affairs Medical Center	Principal Investigator
Steven Woloshin, MD, MS	White River Junction Veterans Affairs Medical Center	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21911629	Derived	Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public: a national randomized trial. Arch Intern Med. 2011 Sep 12;171(16):1463-8. doi: 10.1001/archinternmed.2011.396.