Focus Groups on Oncology Indications

Focus Groups About Drug Products As Used by The Food and Drug Administration

Disclosure Worksheet

Focus Groups on Oncology Indications

OMB: 0910-0677

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0677 can be found here:

2020-01-10 - Extension without change of a currently approved collection

Document [docx]

Download: docx | pdf

Focus Group Workbook – Endpoint Group

Exercise 1

What are some words, thoughts or feelings that come to mind when you hear the term “overall survival”?

__________________________________________

If a drug improves overall survival, it means that the drug might….

__________________________________________

Exercise 2: Overall Survival Definition

Shape1

Circle any words that you think are confusing.

Underline any words or parts of the definition that are clear or explained well.

The length of time that patients are still alive after starting treatment.

Exercise 3

What are some words, thoughts or feelings that come to mind when you hear the term “progression-free survival”?

__________________________________________

If a drug improves progression-free survival, it means that the drug might….

__________________________________________

Exercise 4: Progression-Free Survival Definition

Shape2 Circle any words that you think are confusing.

Underline any words or parts of the definition that are clear or explained well.

The length of time after starting treatment that a patient lives with the disease but it does not get worse.

Exercise 5

What are some words, thoughts, or feelings that come to mind when you hear the term “objective response rate”?

__________________________________________

If a drug improves objective response rate, it means that the drug might…

__________________________________________

Exercise 6: Objective Response Rate Definition

Shape3 Circle any words that you think are confusing.

Underline any words or parts of the definition that are clear or explained well.

The proportion of patients whose tumor shrinks or who have a decrease in the number of detectable cancer cells in their body.

Shape4

“Drug X increased the time patients lived without their multiple myeloma getting worse or passing away from any cause.”

Exercise 7: Progression-free survival

Imagine you wanted to tell your friend or family member about this drug, but you wanted to make sure they knew that the information above does not necessarily mean that the drug will help them live longer, how would you explain that?

______________________________________________________________________________

Shape5

“When taking Drug X, more than half of women saw their tumors shrink:

55.4% of women on Drug X + Drug Y saw their tumors shrink vs 40.2% on Drug Y.”

Exercise 8: Objective Response Rate

______________________________________________________________________________

OMB Control #0910-0677 Expires 05/31/2020

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
Author	Boudewyns, Vanessa
File Modified	0000-00-00
File Created	2021-01-20