Focus Groups on Oncology Indications

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

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Focus Group Workbook – Terminology 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….

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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.

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

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Author	Alexander, Jennifer
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File Created	2021-01-20