Phase 2: Number of Completes

OMB No. 0910-0895: Approval Expires 03/31/2024

FDA Terms and Phrases Study
U.S. Food and Drug Administration
Acting as data collection agent: RTI International

Hello, we are recruiting health care providers for a research study sponsored by the Food and Drug
Administration. The purpose of the study is to find out how people understand words and phrases
that are commonly used in prescription drug advertising.
RTI International, an independent, nonprofit research institute, will be conducting the survey with
health care providers nationwide. The survey will take approximately 20 minutes.
To see if you are eligible to participate, please answer the questions below.
Please place a check mark next to the best answer.

E1.

What percentage of your time do you spend providing direct patient care?
50% or more
Less than 50%

E2.

How many hours a week do you practice medicine?
At least 32 hours
Less than 32 hours

E3.

Continue to Question E2
Please return blank survey in the envelope provided

Continue to Question E3
Please return blank survey in the envelope provided

Have you ever worked for any of the following?
Department of Health and Human Services
U.S. Food and Drug Administration
Market research firm
Pharmaceutical company
RTI International
None of the above

Please return blank survey in the
envelope provided

Continue to next page

Burden Statement
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control
number.

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Consent Form
Introduction and Purpose
You have been invited to take part in a research study. The purpose of the study is to find out how health care providers
understand words and phrases that are commonly used in prescription drug advertising. RTI International, a nonprofit
research organization in North Carolina, is conducting this study on behalf of, and sponsored by, the U.S. Food and Drug
Administration (FDA).
Procedures
You are one of about 1,000 health care providers being asked to participate in this study. If you agree to participate, the
survey should take approximately 20 minutes to complete.
Benefits
There is no direct benefit to you for participating. Your responses are very important because they will help FDA better
understand how to communicate prescription drug information to healthcare providers.
Risks
There are no known risks to participating in this study. We will not ask you any personal health questions, but if any
questions make you uncomfortable, you can refuse to answer. There is also a potential risk of loss of confidentiality. Every
effort will be made to protect your information, but this cannot be guaranteed.
Confidentiality
The privacy and confidentiality of your information is of the highest importance, and we are committed to maintaining a
secure environment in which you can participate. All information you share in this study will be kept confidential to the
extent provided by law. The study team will not reveal your name or any of your responses, and your personal information
(name, address, phone number) will not be linked to any of your responses. The information you share with us will be
combined into a summary report so that details of individual surveys cannot be linked to a specific participant. You will not
be recontacted about this research study in the future. However, once de-identified, your data may be shared with other
researchers or used by RTI/FDA for future research purposes.
Reimbursement
To thank you in advance for your time and participation in the study, we have enclosed a $50 check.
Right to Refuse or Withdraw
Your participation in this study is completely voluntary, and you can withdraw from the study for any reason at any time
without penalty.
Persons to Contact
If you have questions about the study, you can call the project director, Dr. Bridget Kelly, at 1-800-334-8571, ext. 22098.
She can be reached between 9:00 a.m. and 5:00 p.m. Eastern Time Monday to Friday. If you have questions about your
rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.

CONSENT1. Do you agree to participate?
Yes, I consent to participate
Continue to Question 1
No, I do not consent to participate
Please return blank survey in the envelope provided

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Q1. When you read the statement in the column to the left, which of the following come to mind about the drugs
listed? PLEASE CHECK ALL THAT APPLY.

It will
increase
compliance.

The drug
The drug is
does not
taken orally,
involve
not through measurement
The
injection or or cutting pills instructions
infusion.
in half.
are clear.

The drug
does not
have to be
taken at a
specific time
of day.

The drug
does not
have to be
taken with
food.

The drug
does not
require
Other
monitoring of (please
the patient. specify)

This drug is
“convenient.”
This drug is
“straightforward
to use.”
This drug is
“simple to use.”

This drug is
“easy to use.”

Q2. How safe do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Safety cannot be
Somewhat less
compared to
Much less safe
safe
Equally as safe Somewhat safer
Much safer
other drugs
This drug is
“convenient.”
This drug is
“straightforward
to use.”
This drug is
“simple to use.”
This drug is “easy
to use.”

Q3. How effective do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Effectiveness
cannot be
Much less
Somewhat less
Equally as
Somewhat more
Much more
compared to
effective
effective
effective
effective
effective
other drugs
This drug is
“convenient.”
This drug is
“straightforward
to use.”
This drug is
“simple to use.”
This drug is “easy
to use.”

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Q4. When you read the statement in the column to the left, how likely do you think it is that a patient taking
each drug would experience a severe asthma attack? PLEASE SELECT THE RESPONSE FOR EACH
UNDERLINED TERM THAT COMES CLOSEST TO YOUR BELIEFS.
Somewhat
Neither likely nor
Not at all likely
unlikely
unlikely
Somewhat likely Extremely likely
This drug is shown to “prevent”
severe asthma attacks.
This drug is shown to “help
prevent” severe asthma attacks.
This drug is shown to “reduce the
incidence” of severe asthma
attacks.
This drug is “proven to help”
prevent severe asthma attacks.
This drug is “proven effective” at
preventing severe asthma attacks.
Q5. When you read the statement in the column to the left, which of the following come to mind about the
drugs listed? PLEASE CHECK ALL THAT APPLY.
The drug would need to The drug is guaranteed
There is data to
be prescribed in
to be effective at
suggest the drug works combination with other
preventing asthma
as intended.
drugs for this indication.
attacks.
Other (please specify):
This drug is “proven to
help” prevent severe
asthma attacks.
This drug is “proven
effective” at preventing
severe asthma attacks.

Q6. When you read the statement in the column to the left, what comes to mind about the following drugs?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
The drug works The drug works The drug works The drug works
only on a
on a specific only at the site only at the site
specific cause
cause of the or location of the or location of
of the migraine
migraine but
migraine and the migraine but
and does not
may also affect does not affect may also affect
Other
affect any other other parts of any other parts of other parts of
(please
parts of the body
the body
the body
the body
I don’t know
specify)
This drug acts by “targeting”
calcitonin gene related
peptide (CGRP) receptors to
help address migraines.

This drug “acts locally” to
help address migraines.

This drug has a “targeted
mechanism of action” to
help address migraines.

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Q7. When you read the statement in the column to the left, which of the following come to mind about the
drugs listed? PLEASE CHECK ALL THAT APPLY.
It might be
effective on its
It might have
own (not
It works
It has longmore side
require another
Other
better than
lasting
It works
effects than It could be
drug to be
(please
It is strong. other drugs.
benefits.
quickly.
other drugs. addictive.
taken with it).
specify)
This drug is
“powerful.”
This drug is
“potent.”

Q8. How safe do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Safety cannot
Much less
Somewhat
Equally as
Somewhat
be compared
safe
less safe
safe
safer
Much safer to other drugs
This drug is shown to “prevent”…
This drug is shown to “help
prevent”…
This drug is shown to “reduce the
incidence” of…
This drug is “proven to help”…
This drug is “proven effective”…
This drug is made from a “natural”
ingredient.
This drug works by “targeting”…
This drug “acts locally.”
This drug has a “targeted
mechanism of action.”
This drug is “powerful.”
This drug is “potent.”
Q9. How effective do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Effectiveness
cannot be
Much less
Somewhat
Equally as
Somewhat
Much more compared to
effective
less effective
effective
more effective effective
other drugs
This drug is shown to “prevent”…
This drug is shown to “help
prevent”…
This drug is shown to “reduce the
incidence” of…
This drug is “proven to help”…
This drug is “proven effective”…
This drug is made from a “natural”
ingredient.
This drug works by “targeting”…
This drug “acts locally.”
This drug has a “targeted
mechanism of action.”
This drug is “powerful.”
This drug is “potent.”

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Q10. How would knowing that a drug is the “#1 prescribed” drug affect your intention to prescribe the drug?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
Would it make you:
A lot less likely to prescribe it
A little less likely to prescribe it
Neither more nor less likely to prescribe it
A little more likely to prescribe it
A lot more likely to prescribe it
Q11. How would knowing that a drug is the “#1 prescribed” drug affect other providers’ intentions to prescribe
the drug? PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
Would it make them:
A lot less likely to prescribe it
A little less likely to prescribe it
Neither more nor less likely to prescribe it
A little more likely to prescribe it
A lot more likely to prescribe it
Q12. What do you think about a drug when you read that it is the “#1 prescribed” drug? PLEASE CHECK ALL
THAT APPLY.
It is the best available option.
It is safer than other drugs.
It is less expensive than other drugs.
It is more expensive than other drugs.
It is more likely to be covered by insurance than other drugs.
It is the most commonly prescribed.
It is more effective than other drugs.
It is more readily available than other drugs
Other (please specify):

Q13. How safe do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Safety cannot
Somewhat less
Somewhat
be compared
Much less safe
safe
Equally as safe
safer
Much safer to other drugs
This drug is “new.”
This drug “works
differently.”
This drug is the “first and
only” drug to…
This drug is the “first in
class.”
This drug uses a “novel
mechanism of action.”

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Q14. How effective do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Effectiveness
cannot be
Much less
Somewhat
Equally as
Somewhat
Much more compared to
effective
less effective
effective
more effective effective
other drugs
This drug is “new.”
This drug “works differently.”
This drug is the “first and only” drug
to…
This drug is the “first in class.”
This drug uses a “novel mechanism of
action.”
Q15. Which of the following come to mind when you read that a drug has been “FDA approved”?
PLEASE CHECK ALL THAT APPLY.
The drug must not have any serious side effects.
The drug has been evaluated for safety and effectiveness.
The drug offers benefits that are greater than the risks.
The drug is safer than other drugs.
The drug is as safe as other drugs.
Other (please specify):

Q16. Which of the following come to mind when you read that a prescription drug is used “off-label”?
PLEASE CHECK ALL THAT APPLY.
It does NOT have FDA approval for the specific indication for which it is being used.
It does NOT have FDA approval for any use.
It is used for an unapproved age group, dosage, or route of administration.
It is used illegally.
Other (please specify):

Q17. When you read that a drug “reverses” bone loss, what does that mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
It will return bone density to normal.
It will build back bone that was lost.
It will stop bone density loss.
It will slow bone density loss.
Other (please specify):

Q18. Which of the following come to mind when you read, “individual results may vary” in a statement about a
drug? PLEASE CHECK ALL THAT APPLY.
The benefits will generally be the same for everyone.
The benefits will vary from person to person.
It will work for few people.
There is no guarantee it will work for your patient.
Other (please specify):

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Q19.

What do you think about a drug when you read that the difference in effectiveness between it and a
placebo was “not statistically significant”? PLEASE DESCRIBE IN YOUR OWN WORDS:

Q20.

Please read the following four statements:
Statement 1: “This drug offers a manageable safety profile.”
Statement 2: “This drug offers an established safety profile.”
Statement 3: “This drug offers a well-studied safety profile.”
Statement 4: “This drug is well-tolerated.”
Do these four statements mean the same thing or do some of them mean something different to you?
They all mean the same thing.
They mean something different. Please specify the difference:

Q21.

When you read the statement in the column to the left, what comes to mind about the following drugs?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
The drug has fewer
Health care providers
The drug’s risks and
risks and side effects
know how to manage
side effects are well
than other drugs for the
the risks and side
Other
understood.
same condition.
effects.
(please specify):
This drug offers a
“manageable safety
profile.”

This drug offers an
“established safety
profile.”

This drug offers a “wellstudied safety profile.”

This drug is “welltolerated.”

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Q22.

When you read the statement in the column to the left, what comes to mind about the following drugs?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
It will create tissue
It involves building
It will return vaginal that is stronger or
It will relieve
new tissue, but may
tissue to its original
better than the
symptoms of
not return tissue to
Other
condition.
original tissue.
atrophic vaginitis.
its original state.
(please specify):
This drug
“restores” vaginal
tissue.

This drug
“rebuilds” vaginal
tissue.

Q23. How safe do you think each of the following drugs is compared to other drugs for the same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Safety cannot
Much less
Somewhat
Equally as
Somewhat
be compared
safe
less safe
safe
safer
Much safer to other drugs
This drug is the “#1 prescribed”
drug.
This drug is “FDA approved.”
This drug is used “off label.”
This drug “reverses”…
For this drug, “individual results
may vary.”
This drug “restores”…
This drug “rebuilds”…
Q24. How effective do you think each of the following drugs is compared to other drugs for the same
condition? PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST
TO YOUR BELIEFS.
Effectiveness
Somewhat
cannot be
Much less
Somewhat
Equally as
more
Much more
compared to
effective
less effective
effective
effective
effective
other drugs
This drug is the “#1 prescribed”
drug.
This drug is “FDA approved.”
This drug is used “off label.”
This drug “reverses”…
For this drug, “individual results
may vary.”
The difference in effectiveness
between this drug and a placebo was
“not statistically significant.”
This drug “restores”…
This drug “rebuilds”…

9

Q25. How many people out of 100 do you think of when you see each of the following? If you are thinking of a
range, please enter the midpoint of that range.
Many

(Enter a number from 0-100.)

A few

(Enter a number from 0-100.)

Some

(Enter a number from 0-100.)

The majority

(Enter a number from 0-100.)

Most

(Enter a number from 0-100.)

Q26. Please read the following two statements:
“Pharmaceutical companies engage in prescription drug promotion to market their products.”
“Pharmaceutical companies engage in prescription drug advertising to market their products.”
Do these statements mean the same thing or do they mean different things?
They mean the same thing to me.
They mean different things to me. Please specify the difference:

Q27. Which of the following do you think about when you read “prescription drug promotion” and “prescription
drug advertising”? PLEASE CHECK ALL THAT APPLY.
Prescription drug Prescription drug
promotion
advertising
Pharmaceutical detailing visits
Drug information disseminated during medical conferences
Print or web materials (e.g., ads in medical journals) developed specifically for health
care providers about a prescription drug
Television or radio ads about the drug directed at consumers
Print ads in magazines or journals directed at consumers
Website, web, or social media ads about the drug directed at consumers
A coupon, discount, or special offer
Other (please specify):

Q28. Have you ever heard the term “scientific exchange”?
No → Skip to Q30
Yes
Q29. In your own words, what does “scientific exchange” mean to you?

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For the following few questions, we would like you to choose the ONE best answer. Please do not guess. If
you are unsure, please select “I am not familiar with this term.”
Q30. What does “overall response rate” mean to you in the context of cancer care?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
I am not familiar with this term.
The number of patients who started or “responded to” the study.
The percentage of patients whose cancer shrinks or disappears after treatment
How well the drug works.
The percentage of people who are still alive after 5 years or at the conclusion of the study.
Other (please specify):

Q31. What does “response duration” mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
I am not familiar with this term.
The amount of time it takes for the medication to start working.
Once a medication starts working, the amount of time the medication works before disease progression
or relapse.
The amount of time it takes for the medication to start working and the amount of time it works before
disease progression or relapse.
Other (please specify):

Q32. What does “randomized controlled trial” mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
I am not familiar with this term.
A study in which patients are randomly selected to participate.
A study that involves randomly assigning patients to receive the treatment under investigation or a
control (placebo or standard treatment).
A study in which patients receiving the treatment under investigation are matched with a control group
that has similar demographic characteristics.
Other (please specify):

Q33. What does “non-inferiority randomized controlled trial” mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
I am not familiar with this term.
A trial that aims to demonstrate that a treatment is better than another treatment by more than a small
amount.
A trial that aims to demonstrate that a treatment is equivalent to another treatment.
A trial that aims to demonstrate that a treatment is not worse than another treatment by more than a
small amount.
Other (please specify):

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Q34. What does “intent-to-treat analysis” mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
I am not familiar with this term.
Results are based on the participants’ original random assignment, regardless of whether they
completed the protocol or actually received the treatment.
Results are based on the final treatment received, regardless of which group patients were originally
assigned to.
Analyses include only those participants who completed the study.
Analyses include those populations you most want to treat for a specific condition.
Analysis includes all available treatments providers intend to use for a medical condition.
Other (please specify):

Q35. What does “per-protocol analysis” mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
I am not familiar with this term.
Results are based on the final treatment received, regardless of which group patients were originally
assigned to.
Analyses include only those participants who completed the study.
Analysis of whether the study is being conducted according to the protocol identified at the start
Results are based on the participants’ original random assignment, regardless of whether they
completed the protocol or actually received the treatment.
Other (please specify):

Thank you for answering those questions. Now, we just have a few more questions about you:

Q36.

Are you Hispanic or Latino?
Yes
No

Q37.

What is your race? You may select one or more races.
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
Prefer not to answer

Q38. In what states are you currently practicing?

That concludes the survey.
Thank you for your time. Your responses will help make prescription drug information clearer. Please place the
completed survey in the provided envelope and return it at your earliest convenience.

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