Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020

Biosimilars Patient Study

Focus Group Eligibility and Scheduling Confirmation Script

Note: This script will be used only for individuals who complete the web screener.

Hello, this is ____ calling from Survey Healthcare Globus. I’m calling regarding the online focus group study about health-related materials you recently expressed interest in.

I’m calling to confirm a few pieces of information you shared with us to ensure you are eligible. If you are, I would like to schedule you to participate in one of the focus groups. As a reminder, this study will involve a 90-minute online focus group, and you will receive $75 if you complete the study.

Can I ask you a few questions now to confirm your eligibility and schedule your participation?

• Yes  CONTINUE

• No  Would another time be better? [Schedule a time to call back]

Medication Use – Illness Conditions

[Ask of all participants assigned to patient segments, except diabetes]

1. Is it correct that you have previously taken [medication] for [condition]?

• Yes  CONTINUE

• No  UPDATE RESPONSE AND CONFIRM STILL ELIGIBLE

[Repeat Q1 for each medication selected on screener]

2. Is it correct that you have taken [medication] in the past 6 months or are still taking it?

• Yes  CONTINUE

• No  UPDATE RESPONSE AND CONFIRM STILL ELIGIBLE

Audience Segmentation – Adults with Diabetes

[Ask of all participants assigned to adults with diabetes segment]

3. Is it correct that you have been using insulin to treat your diabetes for at least one month?

• Yes  CONTINUE

• No  TERMINATE

4. Is it correct that you take insulin once or more per day?

• Yes  CONTINUE

• No  TERMINATE

Audience Segmentation – Children with Diabetes

[Ask of all participants assigned to parents/caregivers of children with diabetes segment]

5. Is it correct that your child has been using insulin to treat his or her diabetes for at least one month?

• Yes  CONTINUE

• No  TERMINATE

6. Is it correct that your child takes insulin once or more per day?

• Yes  CONTINUE

• No  TERMINATE

Computer and Internet Access

7. Is it correct that you have high-speed Internet at home? That is, are you able to stream video without any difficulty?

• Yes  CONTINUE

• No  TERMINATE

8. Is it correct that you have a computer (not just a tablet or smartphone) and a web cam that you can use during the focus group?

• Yes  CONTINUE

• No  TERMINATE

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 – Scheduling Script

Thank you for confirming that information. You qualify for our study. Next, I’d like to schedule you for a focus group. The focus group will last about 90 minutes. You will receive a $75 honorarium once the sessions are finished and the project has concluded. Specific instructions for obtaining your honorarium will be sent to your email at the conclusion of the research. Survey Healthcare Globus uses third party providers, such as TangoCard and PayPal, to provide the honorarium.

Scheduling of Focus Group Participation

Are you available at [TIME] on [DATE]? [READ GROUP TIME OF RELEVANT CONDITION]

• Yes  CONTINUE and schedule participant for appropriate group

• No  Are you available at [TIME] on [DATE]? [READ ALTERNATIVE GROUP TIMES OF RELEVANT CONDITION, IF AVAILABLE]

  • Yes  CONTINUE and schedule participant for appropriate group

  • No  RECORD RESPONSE, RETAIN PARTICIPANT AS AN ALTERNATE, AND END CALL

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 focus group on [DATE/TIME]. We will also use this information to send you a reminder email and to call and remind you of the focus group one day before the group.

Thank you. We appreciate your participation in this study.

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