Testing the Effect of a Warning About New Drugs
1 other identifier
interventional
2,944
0 countries
N/A
Brief Summary
The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 31, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedApril 9, 2010
July 1, 2009
Same day
July 30, 2009
April 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Hypothetical choice of old (vs. newer) drug
0 weeks (assessed during intervention)
Secondary Outcomes (1)
Comprehension of the drug warning and drug information
0 weeks (assessed during intervention)
Study Arms (3)
Directive new drug warning
EXPERIMENTALSurvey 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.
Non-directive new drug warning
EXPERIMENTALSurvey 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.
No new drug warning
EXPERIMENTALSurvey contains information about when the drug was approved by the FDA (2009) only.
Interventions
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
Eligibility Criteria
You may qualify if:
- Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21911629DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
July 30, 2009
First Posted
July 31, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
April 9, 2010
Record last verified: 2009-07