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Flashcards in Trials and stats Deck (16)
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1
Q

What is the aim of a phase 1 trial?

A

Seeking maximum tolerated dose (MTD) e.g. toxicity

2
Q

What is the definition of dose limiting toxicity (DLT)?

A

unacceptable toxicity within cycle 1

3
Q

what is the definition of maximum tolerated dose (MTD)?

A

where 20-30% have observed DLT

4
Q

How is the recommended phase 2 dose (RP2D)?

A

Usually ≤ MTD

5
Q

What is the aim of a phase 2 study?

A

Characterise safety and toxicity of drug therapy

6
Q

What is the difference between Adverse event (AE) and Reaction (AR)

A

AE are not related to treatment but AR are

7
Q

Who can determine casualty between AE and drug in a trial?

A

medical trained fellow and the principle investigator

8
Q

Who is responsible for the OVERALL conduct

of a trial?

A

Sponsor

9
Q

What does “fast track” relate to in facilitating faster drug approval?

A

Speeds up new drug review

10
Q

What does “break through” relate to in facilitating faster drug approval?

A

shortens development time of promising new therapy which has preclinical data

11
Q

What does “Priority review” relate to in facilitating faster drug approval?

A

review at 6m rather than 10m

12
Q

What does “Accelerated review” relate to in facilitating faster drug approval?

A

uses surrogate endpoint in drugs with benefit in serious conditions. End points will be confirmed later.

13
Q

What does random assignment do in RCT?

A
  • removes bias
  • produces comparable groups
  • allows statistical test to have significance
14
Q

Disadvantages of RCT?

A

Not always generalisable
Large recruitment needed
Acceptability of randomness
Administrative complexity

15
Q

What type of biomarkers are there?

A
risk/predisposition 
screening
diagnostic 
prognostic 
predictive 
Pharmacological
16
Q

What is an example of a diagnostic biomarker?

A

Mammogram