Focus Group Testing of Consumer Messaging on Participation of Diverse Women in Clinical Trials

Group: ___________

Date: ___________

OMB: 0910-0497

Diverse Women in Clinical Trials

Please use the Fact Sheet to answer the following questions. Do not put your name on this sheet.

Put a  next to the one (1) most important message in the Fact Sheet. [ORDER TO BE CHANGED WITH EACH FOCUS GROUP]

☐ Talk to the researcher to get the facts about the clinical trial before you join.

☐ It is important that women participate in clinical trials to show if products are safe and work well in both men and women.

☐ FDA uses the information from clinical trials and other sources to decide if a product is safe and effective.

☐ FDA and NIH have websites where you can learn more about clinical trials.

Circle TRUE or FALSE for each statement below based on the information in the Fact Sheet.

1. Not all products are tested in clinical trials. TRUE FALSE

2. FDA runs clinical trials. TRUE FALSE

3. Medical products affect men and women the same way. TRUE FALSE

4. The treatments in a clinical trial may not work for everyone. TRUE FALSE

5. Healthy people can participate in clinical trials. TRUE FALSE

Circle the answer that best describes how much you agree with the statement below.

After reading the fact sheet, I would consider participating in a clinical trial.

Strongly Agree Agree Undecided Disagree Strongly Disagree

Paperwork Reduction Act 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.

The public reporting burden for this information collection has been estimated to average 25 minutes per response to complete the Women in Clinical Trials Fact Sheet (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to [email protected].

GENERAL MESSAGE TESTING

Please circle the word that best describes your feeling and first reaction to the message. Be HONEST! If you think of more words or better feelings to describe your reaction, please write the word below too.

MESSAGE 1:

Confusing Clear Not about me

Interesting already know bossy dull

Inviting useless important helpful

Informs talks down friendly boring

Practical easy makes sense scary

Please circle the word that best describes your feeling and first reaction to the message. Be HONEST! If you think of more words or better feelings to describe your reaction, please write the word below too.

MESSAGE 2:

Confusing Clear Not about me

Interesting already know bossy dull

Inviting useless important helpful

Informs talks down friendly boring

Practical easy makes sense scary

MESSAGE 3:

Confusing Clear Not about me

Interesting already know bossy dull

Inviting useless important helpful

Informs talks down friendly boring

Practical easy makes sense scary