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PHARM 312 (Final) > Non-Inferiority > Flashcards

Non-Inferiority Flashcards

1
Q

Superiority
- What is it

A

To prove if an intervention is better than another
- Superiority vs Placebo

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2
Q

Superiority
- Hypothesis Testing

A

Null Hypothesis: Assume at first that treatment has no effect

Alternative Hypothesis: Assume there is a difference between groups

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3
Q

Superiority
- Rejecting Null Hypothesis

A

Just because we do not reject the null hypothesis does not mean that the null hypothesis is true

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4
Q

Equivalence
- What is it

A

To prove if an intervention is similar to another

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5
Q

Equivalence Trials

A

Seeks to rule out differences between two treatments
- To establish bioequivalence

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6
Q

Bioequivalence

A

If CI is equal to 1 equivalent

If CI does not contain 1 equivalent

If CI contains 1 and is not equal to 1 NO equivalence

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7
Q

Non-inferiority

A

To prove if an intervention not worse than another drug

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8
Q

When are NIFT preferred

A

CVOT in diabetes
Antibiotics
New Inhaled COPD Therapy
New Oral anticoagulants in atrial fibrillation

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9
Q

NIFT
- Hypothesis Testing

A

Null Hypothesis
- There is a difference between the groups

Alternative Hypothesis
- Difference between new and old intervention is less than ___

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10
Q

Non-Inferiority and Superiority

A

A non-inferiority trials can show superiority
- Must show non-inferiority first and then superiority

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11
Q

Interpreting NIFT

A

Three Interpretations
1. Both drugs are equal
2. Both drugs are ineffective
3. The trial could not find a differnce
–> However, does not mean they are equivalent

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12
Q

Common errors in NIFT

A
  1. Just because the trial fails to find a difference does not make the groups equivalent
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13
Q

Intention to Treat vs Per Protocol Analysis

A

Use Intention To Treat for Non-Inferority Trials
- ITT favours no difference (underestimates)
- PPA favours a difference (favours against non-inferiority) (overestimates)

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14
Q

How to tell if a trial has Non-Inferiority Goal

A

The intervention is not that much worse than the control

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15
Q

Margin of Inferiority

A

50% of the minimal treatment effect of the active control should be preserved
- Want to use the smallest acceptable degree of clinical inferiority (Want to show no important loss of efficacy)

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16
Q

How to calculate margin of inferiority

A

Use relative risk or odds ratio
(Should be less than 1.3)
- Absolute risk reduction can influence bias and result in underpowered trial

17
Q

Non-Inferiority and Sample Size

A

The smaller the inferiority margin the more study subjects needed

18
Q

Additional Questions to ask for Non-Inferior Trials

A
  • Did the investigators guard against unwarranted conclusions of non-inferiority
  • Was the effect of standard treatment preserved
  • Did investigators analyze patients to the groups they were assigned to
19
Q

Additional Analysis for Risk of Bias

A
  1. Ensure active control was proven to be effective
  2. Ensure patients and outcomes are similar to original trials of active control
  3. Ensure both regiments were applied optimally
  4. Ensure patients are analyzed to treatment they received AND the group they were assigned to
  5. Ensure Non-Inferiority margin was specified
  6. Ensure sample size is large enough
20
Q

Type I Error

A

Concluding there is a difference when there is no difference
- False Positive

Alpha is the probability of making a type 1 error
(Is set at 0.05)

21
Q

Type II Error

A

Concluding there was no difference when there was a difference
- False Negative

Beta is the probability of making a type 2 error
(Main determinant is sample size)

22
Q

Issues with Superiority Trials

A
  • Unethical to do placebo
  • Regulatory agency wants clinical endpoint trials instead of surrogate endpoint trials
  • Benefit of therapies is getting smaller
  • May want to prove drug is efficacious
23
Q

CI is to the left of HR (1)

A

Superior and Non-Inferior

23
Q

CI touches HR (1)

A

Non-Inferior

23
Q

CI touches Non-Inferiority Boundary and is to the right of HR (1)

A

Inferior

23
Q

CI touches Both Non-Inferiority Boundary and is to the right of HR (1)

A

CI touches HR (1) and Both Non-Inferiority Boundary
- Underpowered
- Not approvable

23
Q

CI is to the right of HR (1)

A

Non-inferior
- Though new treatment is worse technically

23
Q

FRISBE

A

Follow Up
Randomization / Allocation Concealment
Intention to Treat
Similar Base Line
Blinding
Equal Treatment

23
Q

Superiority vs Non-Inferiority
- F

A

Superiority
- Follow Up should be complete as possible
Non-Inferiority
- Follow Up should be complete as possible
- May need to be longer to see a difference

23
Q

Superiority vs Non-Inferiority
- R

A

Superiority
- Randomization and Allocation Concealment are both desirable
Non-Inferiority
- Randomization and Allocation Concealment are both desirable

23
Q

Superiority vs Non-Inferiority
- I

A

Superiority
- Use ITT to preserve randomness
- Harder to find differences when using ITT

Non-Inferiority
- ITT benefits Non-inferiority
- Wants to use ITT and PPA with consistient results
- Use PPA first to assess hypothesis and then use ITT to support

23
Q

Superiority vs Non-Inferiority
- S

A

Superiority
- Verifies balanced randomization
- Wants similar groups

Non-Inferiority
- Verifies balanced randomization
- Wants similar groups

23
Q

Superiority vs Non-Inferiority
- B

A

Superiority
- To prevent placebo
- To prevent contamination

Non-Inferiority
- To prevent placebo
- To prevent contamination

23
Q

Superiority vs Non-Inferiority
- E

A

Superiority
- Wants no differences in treatment except intervention
- Wants NO contamination
- Wants NO co-intervention

Non-Inferiority
- Wants no differences in treatment except intervention
- Wants NO contamination
- Wants NO co-intervention
- Even more picky about contamination as it makes it harder to find differences

23
Q

CI touches HR (1) and Non-Inferiority Boundary

A

Non-Inferiority is NOT shown

PHARM 312 (Final) (16 decks)

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