Risk CommunicationNCT00950157
Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
A study testing Presentation of information on approval based on a surrogate outcome and levels of caution in people with Risk Communication, run by White River Junction Veterans Affairs Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Communication
- What is being tested?
- Presentation of information on approval based on a surrogate outcome and levels of caution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,944 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
Who cannot join
None listed.
About this study
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
- Being tested
- Presentation of information on approval based on a surrogate outcome and levels of caution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presentation of information on approval based on a surrogate outcome and levels of cautionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Directive "open question" statement | Experimental | Survey describes the surrogate outcome of the drug along with a directive warning (i.e., stating the issue and why it matters) for drugs shown to improve surrogate outcomes.
This directive warning mentions that it is not known whether the drug will help patients feel better, and that readers should ask their doctor if there is an available drug shown to improve patient outcomes. Receives: Other: Presentation of information on approval based on a surrogate outcome and levels of caution |
| Non-directive open question statement | Experimental | Survey describes the surrogate outcome of the drug along with a non-directive warning (i.e., stating the issue only) for drugs shown to improve surrogate outcomes.
This non-directive warning mentions only that it is not known whether the drug will help patients feel better. Receives: Other: Presentation of information on approval based on a surrogate outcome and levels of caution |
| No open question statement | Experimental | Survey only describes the surrogate outcome of the drug. Receives: Other: Presentation of information on approval based on a surrogate outcome and levels of caution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes
Measured: 0 weeks (assessed during intervention)
Secondary outcomes (1)
Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes
Measured: 0 weeks (assessed during intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,944 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Attorney General Consumer & Prescriber Education Grant
- Investigators
- Lisa M Schwartz, MD, MS, Principal investigator, White River Junction Veterans Affairs Medical CenterSteven Woloshin, MD, MS, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950157
- Sponsor's protocol ID
- 16785
- Status last verified
- Jun 2011
- First submitted
- 30 Jul 2009
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21911629
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
- ClinicalTrials.gov ID
- NCT00950157
- Acronym / sponsor ID
- 16785
- Conditions
- Risk Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,944 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Attorney General Consumer & Prescriber Education Grant
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Directive "open question" statement | Experimental | Other: Presentation of information on approval based on a surrogate outcome and levels of cautionSurvey describes the surrogate outcome of the drug along with a directive warning (i.e., stating the issue and why it matters) for drugs shown to improve surrogate outcomes. This directive warning mentions that it is not known whether the drug will help patients feel better, and that readers should ask their doctor if there is an available drug shown to improve patient outcomes. |
| Non-directive open question statement | Experimental | Other: Presentation of information on approval based on a surrogate outcome and levels of cautionSurvey describes the surrogate outcome of the drug along with a non-directive warning (i.e., stating the issue only) for drugs shown to improve surrogate outcomes. This non-directive warning mentions only that it is not known whether the drug will help patients feel better. |
| No open question statement | Experimental | Other: Presentation of information on approval based on a surrogate outcome and levels of cautionSurvey only describes the surrogate outcome of the drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Presentation of information on approval based on a surrogate outcome and levels of cautionPresentation 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. | Other | Directive "open question" statement, No open question statement, Non-directive open question statement |
Primary outcome
Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes
Time frame: 0 weeks (assessed during intervention)
1 secondary outcome
Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes
Time frame: 0 weeks (assessed during intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
- Derived from this study: PubMed 21911629Schwartz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Schwartz, MD, MS principal investigator
White River Junction Veterans Affairs Medical Center
Steven Woloshin, MD, MS principal investigator
White River Junction Veterans Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Presentation of information on approval based on a surrogate outcome and levels of caution in people with Risk Communication, run by White River Junction Veterans Affairs Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes (time frame: 0 weeks (assessed during intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.