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

Dear [PARTICIPANT FIRST NAME]:

Thank you for agreeing to join our focus group about health-related materials. The video discussion is scheduled for [DAY, DATE] at [START TIME – END TIME] Eastern Time. It will take place online and will last about 90 minutes. Before you join the discussion, we’d like you to review some important information and complete the two steps described below.

STEP 1: COMPLETE CONSENT FORM

First, please read the study’s consent form, which you can access via the link below. It explains the purpose of our discussion and outlines your rights and responsibilities as a participant. If you agree to participate, you must complete the form at least 48 hours prior to the group. After you complete the form, Survey Healthcare Globus will e-mail you a downloadable copy for your records.

Study Consent Form

[LINK HERE]

For study purposes, the focus group will be audio and video recorded.

STEP 2: CONDUCT VIDEO TEST

You will need a desktop or laptop computer (not a tablet or a smartphone) and web camera to participate in the online discussion. The discussion will be conducted through the interactive website FocusVision InterVu.

A representative from FocusVision will contact you by email in the next few days to schedule a test of the InterVu website and make sure you can access it. This test is important to make sure the website works for you. If you have trouble accessing the website, we can try to fix the problem before the group discussion. You will not be allowed to participate in the group if the website does not work on your computer.

Participants who try to join the focus group late will not be allowed to join.

HELPFUL HINTS

In order to make the most of the discussion, please follow these helpful hints:

1. Log in at least 15 minutes before the group is scheduled to start. This allows you to test your login information and become familiar with the online format. Again, late participants will not be allowed to join the group.

2. Technical problems. If you experience technical problems when logging into the group, please call FocusVision at [Support Number] for support.

3. Minimize distractions. You will need to be seated at a computer with a webcam in order to participate. Please choose a quiet room where you can participate in private and without any distractions or noise. Alert others in advance that you are giving your full attention to the discussion. Turn off your cell phone, television, and anything else that might distract you.

PERSONS TO CONTACT

RTI International, a non-profit research organization based in North Carolina, is conducting this study on behalf of the U.S. Food and Drug Administration (FDA). Survey Healthcare Globus is helping to identify study participants and coordinate their participation.

If you have any questions about this study, you can contact the Survey Healthcare Globus project manager, Anne Marie Bary, at (646) 616-9170 or [email protected].

LOGIN INFORMATION

A FocusVision representative will contact you separately and provide you with the login information needed to join the online group discussion. You should receive this information no later than 24 hours before the focus group is scheduled to begin.

Thank you again for your interest. We look forward to seeing you online soon!