Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)
Data to Support Drug Product Communications
Recruitment Screener - Phone
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)
OMB: 0910-0695
OMB#
0910-0695 
Exp. 3/31/2024
Patient Interview Screener
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0695 and the expiration date is 3/31/2024. The time required to complete this information collection is estimated to average 5 minutes per response to answer the questions to determine eligibility. [Only read above if respondent asks about the OMB control number] |
Biosimilars Patient Study
Introduction
Hello, my name is _____________ from L&E Research. May I please speak to_____________? I’m calling to invite you to participate in an online interview sponsored by the U.S. Food and Drug Administration to get your feedback on health-related materials about a specific type of medicine.
The interview will be led by a researcher through an online video platform, and if you’re eligible, you can participate from home using a computer and web camera. The discussion will last about 90 minutes. You will be emailed about your $75 honorarium within one business day after the interview concludes and have the option to choose between a physical or electronic gift card.
May I ask you a few questions now to see if you are eligible?
Core Eligibility Questions
What is your age?
Age 18 or older |
|
CONTINUE |
Under 18 |
|
TERMINATE |
___ years
Have you ever worked…? [Read list. Accept multiple responses.]
For a drug or pharmaceutical company
TERMINATE
For a market research or marketing company, including RTI International or L&E Research
TERMINATE
For the U.S. federal government (not including as a member of the military)
TERMINATE
As a medical professional (such as a physician, nurse, or pharmacist)
TERMINATE
None of the above
CONTINUE
When was the last time you participated in an interview or a focus group for a research study?
Within the last 6 months
TERMINATE
More than 6 months ago
CONTINUE
Never
CONTINUE
Don’t know
TERMINATE
To participate in this study, you will need a desktop computer, laptop computer, or a tablet, not just a smartphone. Which type of device are you most likely to use if you participate in the study?
Desktop computer
CONTINUE
Laptop computer
CONTINUE
Tablet (e.g., iPad)
I don’t have any of the devices listed above
TERMINATE
To participate in this study, you will also need a webcam attached or built into the device and high-speed internet access. Can you meet these requirements?
Yes
CONTINUE
No
TERMINATE
Do you have any vision, hearing, or speaking issues that would prevent you from reviewing English-language written materials and videos during the interview?
Yes
No
CONTINUE
Are you ok with being audio and video recorded during the interview?
-
Yes
CONTINUE
No
TERMINATE
Audience Segmentation Questions
Has a healthcare professional ever diagnosed you with any of the following medical conditions? [Read list of conditions. Only read detailed description of a condition if requested by individual. Accept multiple responses.]
Ankylosing spondylitis / Spondyloarthritis Inflammatory disease that can cause vertebrae in the spine to fuse. |
|
Ask Q9, then CONTINUE to Q14 |
Psoriatic arthritis A form of arthritis that affects some people who have psoriasis. |
|
Ask Q9, then CONTINUE to Q14 |
Rheumatoid arthritis A chronic inflammatory disorder that can affect joints and other body systems. |
|
Ask Q9, then CONTINUE to Q14 |
Cancer A variety of conditions involving abnormal cell growth. |
|
Ask Q9, then CONTINUE to Q10 |
Crohn’s disease A bowel disease involving inflammation of the digestive tract. |
|
Ask Q9, then CONTINUE to Q14 |
Ulcerative colitis A bowel disease that affects the large intestine with inflammation and ulcers or sores. |
|
Ask Q9, then CONTINUE to Q14 |
Eczema / Atopic dermatitis A skin condition involving itchy rashes. |
|
Ask Q9, then CONTINUE to Q14 |
Psoriasis A chronic skin condition where cells build up rapidly on the skin, forming itchy and sometimes painful scaly red patches. |
|
Ask Q9, then CONTINUE to Q14 |
Type 1 diabetes A chronic condition in which the pancreas produces little or no insulin. |
|
Ask Q9, then CONTINUE to Q12 |
Type 2 diabetes A disease that occurs when not enough insulin is produced or when your body has difficulty using insulin properly. |
|
Ask Q9, then CONTINUE to Q12 |
None of the above |
|
SKIP to Q14 |
How long ago were you diagnosed with [condition]? [Ask for each condition selected by respondent]
Segmentation Questions – Cancer
Which type(s) of cancer were you diagnosed with? [Accept multiple responses]
Breast
CONTINUE
Colorectal
CONTINUE
Kidney
CONTINUE
Leukemia
CONTINUE
Lung
CONTINUE
Lymphoma
CONTINUE
Myeloma
CONTINUE
Skin
CONTINUE
Other (please specify)
Have you ever been diagnosed by a healthcare professional with neutropenia, a blood-related side effect of chemotherapy?
Yes |
|
CONTINUE to Q14 |
No |
|
CONTINUE to Q14 |
Segmentation Questions – Diabetes
How long have you been using insulin to treat your diabetes? [Read list]
More than one month
CONTINUE
Less than one month
SKIP to Q14
Not currently taking insulin
SKIP to Q14
Do you take insulin at least once per day?
Yes |
|
CONTINUE to Q14 |
No |
|
CONTINUE to Q14 |
Segmentation Questions – Children with Diabetes
Are you the parent or guardian of a child who has been diagnosed with diabetes by a healthcare professional? If so, which type of diabetes?
Yes, type 1 diabetes
CONTINUE
Yes, type 2 diabetes
CONTINUE
No
SEE Q19 INSTRUCTIONS
What is this child’s age?
-
Age 18 or older
TERMINATE IF Q8=None of the above
Under 18
CONTINUE
How involved are you in managing your child’s diabetes, for example, scheduling doctor’s appointments, making medication decisions, and administering insulin? Would you say you are...? [Read list]
Extremely involved
CONTINUE
Frequently involved
CONTINUE
Somewhat involved
SEE Q19 INSTRUCTIONS
Not at all involved
SEE Q19 INSTRUCTIONS
How long has your child been using insulin to treat his or her diabetes? [Read list]
More than one month
CONTINUE
Less than one month
SEE Q19 INSTRUCTIONS
Not currently taking insulin
SEE Q19 INSTRUCTIONS
Does your child take insulin at least once per day?
Yes |
|
SEE SKIP PATTERN BELOW |
No |
|
SEE SKIP PATTERN BELOW |
[Skip pattern:
If individual’s responses have checked one or more of the yellow boxes, proceed to Q19.
If individual’s responses have checked only the green boxes, skip to Q24.
If no yellow or green boxes selected, terminate and read closing script.]
MEDICATION QUESTIONS
Now I’d like to ask about medicines that you take for your health conditions. Have you ever taken one or more of the following medicines to treat [list condition(s) for a max of three condition(s) based on responses to Q8, Q10, and Q11]?
[Read list of medicines for each applicable medical condition. Do NOT read “Biosimilar” flag next to medication name.]
[Record multiple responses. If one or more medications selected, continue to Q20. If no medications selected, terminate.]
[RECRUIT AT LEAST 20% TAKING AT LEAST ONE BIOSIMILAR]
-
Selected one or more medicines
CONTINUE
Did not select any medicines for applicable conditions
TERMINATE
List of Medicines for Q19
Condition |
Medicines Brand Name [pronunciation] [generic Name] |
Ankylosing Spondylitis/ Spondyloarthritis |
|
Psoriatic Arthritis |
|
Rheumatoid Arthritis |
|
Cancer (leukemia) |
|
Cancer (blood – including lymphoma and myeloma) |
|
Cancer (lung) |
|
Cancer (skin—melanoma, squamous cell carcinoma, basal cell carcinoma) |
|
Cancer (colorectal) |
|
Cancer (breast) |
|
Cancer (kidney) |
|
Cancer (other types) |
|
Neutropenia (from cancer treatment) |
|
Crohn's Disease |
|
Ulcerative Colitis |
|
Eczema/Atopic Dermatitis |
|
Psoriasis |
|
Are you still taking [list biologics selected in Q19, one at a time]? [Record response for each medicine]
Yes
CONTINUE
No
SKIP TO Q22 IF NO TO ALL MEDS
How long have you been taking [list biologics currently taking, one at a time]? [Record response for each medicine]
Less than one month
TERMINATE
1-3 months
CONTINUE to Q22
4-6 months
CONTINUE to Q22
7-12 months
CONTINUE to Q22
More than one year
CONTINUE to Q22
When did you last take [list biologics selected in Q19 that individual is not currently taking, one at a time]? [Record response for each medicine]
Within the last month
CONTINUE
1-3 months ago
CONTINUE
4-6 months ago
CONTINUE
More than 6 months ago
TERMINATE
How long did you take [list of biologics selected in Q19 that individual is not currently taking, one at a time] when you were still using it? [Record response for each medicine]
Less than one month
TERMINATE
More than one month
CONTINUE to Q24
Would you be comfortable discussing this medicine/these medicines in an interview?
Yes |
|
ELIGIBLE |
No |
|
TERMINATE |
Demographic Questions
What is the highest level of education you have completed? [Read list]
Less than high school diploma [Eligible for lower education groups]
High school graduate or GED [Eligible for lower education groups]
Some college
Technical or Associates degree (2-year)
4-year degree
Graduate or professional degree [RECRUIT NO MORE THAN 14% OF SAMPLE]
What type of health insurance do you currently have? [Read list. Accept multiple responses]
Private insurance through an employer, group health plan, broker, agent, or Federal or state marketplace plan
Medicaid or Medicare [RECRUIT AT LEAST 30% OF TOTAL SAMPLE NON-PRIVATE]
Veterans Affairs, Tricare, or the Department of Defense [RECRUIT AT LEAST 30% OF TOTAL SAMPLE NON-PRIVATE]
Currently uninsured
Other [please specify]: _______________________
What is your race? You may select more than one. [Read list. Accept multiple responses]
White [RECRUIT NO MORE THAN 80% OF SAMPLE]
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaska Native
Are you of Hispanic, Latino, or Spanish origin?
Yes [RECRUIT AT LEAST 15% OF SAMPLE]
No
In which state do you live? [Record response, then sort into corresponding Census region]
-
Record participant response: ________
Midwest - IL, IN, IO, KS, MI, MN, MO, NE, ND, OH, SD, WI [RECRUIT AT LEAST 20% OF SAMPLE]
Northeast - CT, MA, ME, NH, NJ, NY, PA, RI, VT [RECRUIT AT LEAST 20% OF SAMPLE]
South - AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, WV [RECRUIT AT LEAST 20% OF SAMPLE]
West - AK, AZ, CA, CO, HI, ID, NM, MT, OR, UT, NV, WA, WY [RECRUIT AT LEAST 20% OF SAMPLE]
What was your total household income before taxes during the past 12 months? Your response will be kept private.
$30,001 to $65,000
$65,001 to $99,999
More than $100,000
Prefer not to answer
What is your sex?
Closing Scripts
Ineligible - Closing Script
I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.
Eligible – Closing Script
Thank you for answering my questions. You qualify for our study. Next, I’d like to schedule you for an online interview. The interview will last about 90 minutes. You will be emailed about your $75 honorarium within one business day after the interview concludes and have the option to choose between a physical or electronic gift card.
The interviews will take place on [DATES AND TIMES]. Which date and time would work best for you? [Schedule participant for an appropriate interview]
The e-mail address I have on file for you is [E-MAIL ADDRESS] and phone number is [PHONE NUMBER]. Are those still correct? [UPDATE IF NEEDED]
We will reach out with a confirmation email and phone call with instructions to join the interview on [DATE/TIME]. We will also use this information to send you a reminder email and to call and remind you of the interview one day before.
Your participation in this study is very important. If for some reason you will not be able to attend, please let us know right away. You can call us anytime at [insert phone number], and if we are not here, please leave a message.
Thank you. We appreciate your participation in this study.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Alexander, Jennifer |
| File Modified | 0000-00-00 |
| File Created | 2022-07-01 |
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