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Flashcards in Clinical trials Deck (15)
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1
Q

The aim of phase 1 studies is what?

A
  1. To determine toxicity

2. To establish maximum tolerated dose (MTD)

2
Q

Are drugs with no clinically activity rejected in phase 1?

A

No - disease response is not an endpoint, so drugs with no clinical activity are not rejected at this stage

3
Q

What does LD10 mean?

A

10% of the dose that is lethal in 10% of mice - dose escalation is performed using this

4
Q

How is dose escalated and toxicity measured?

A

3 patients are treated at each dose level until side effects are seen, and then 6 patients per group until the maximum tolerated dose is reached

5
Q

What patients are suitable for phase 1 trials?

A

Patients with any tumour, in whom no conventional therapy is appropriate. Patients must remain generally fit and in particular have near normal renal and hepatic function

6
Q

Are phase 1 trials randomized or comparative?

A

no

7
Q

What is the aim of phase 2 trials?

A

To assess the particular anti-tumour activity of a new treatment in a range of different cancers chosen based upon the scientific knowledge of the cancer and the drug

8
Q

What is the primary outcome measured in phase 2 trials?

A

the response rate (shrinkage of the tumour)

9
Q

do you need a control arm and random allocation in all phase 2 trials?

A

no - but can be useful as provides a guide to patients selection, avoids criticism of undue case selection

10
Q

What is the purpose of phase 3 studies?

A

conclude if a treatment is an improvement upon existing options

11
Q

What study design do phase 3 studies normally take?

A

randomised controlled trials to compare with established treatments

12
Q

What are the common primary end points in phase 3 studies?

A

The length of life whatever the cause of death (overall survival)
or the length of life until the cancer grows (progression-free survival)

13
Q

What are common secondary end points in phase 3 trials?

A
radiological shrinkage (response rate)
quality of life
14
Q

Why do phase 3 trials often need multicentres?

A

Need more patients for better statistical significance

15
Q

How is survival data generally presented?

A

Kaplan meier curves