Focus Groups on Oncology Indications

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”?

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

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Exercise 2: Overall Survival Definition

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”?

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

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Exercise 4: Progression-Free Survival Definition

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”?

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

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Exercise 6: Objective Response Rate Definition

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.

“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?

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“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

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?

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