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Clinical Trials Flashcards

1
Q

Define a clinical trial

A
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2
Q

What is the purpose of a clinical trial?

A

To provide reliable evidence of treatment efficacy and safety

Reproducible - in experimental conditions
Controlled - comparison of interventions
Fair - unbiased without confounding

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3
Q

Define efficacy

A

Ability of a health care intervention to improve the health of a defined group under specific conditions

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4
Q

Define safety

A

The ability of a health care intervention not to harm a defined group under specific conditions

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5
Q

What are the phases of drug development?

A
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6
Q

What are the most important ethical considerations for a clinical trial

A

Trials of new drugs may do harm

So.. should only perform if you don’t know what is the best treatment for patients

Patients must understand what participation involves

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7
Q

What are non-randomised clinical trials?

A

Allocation of patients receiving new treatment to compare with patients receiving standard treatment

Allocation by: site; historical controls; system

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8
Q

What are the disadvantages of NRCT?

A

Allocation bias - by patient, clinician, or investigator

Confounding - known, unknown

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9
Q

Describe the use of historical controls in NRCT

A

Comparison of a group of patients who had standard treatment with a group of patients receiving new treatment

BUT for historical group control:

  • selection less rigorous/ well defines
  • treated differently from ‘new treatment’ group
  • less information about bias/ confounders
  • unable to control for confounders
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10
Q

What is random allocation?

A

Allocate participants to treatments fairly

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11
Q

What are the advantages of random allocation?

A

Eliminates allocation bias - each participant has equal chance of being allocated to each treatment

Minimal confounding - in the long run, groups are similar in size and characteristics by chance

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12
Q

What is a confounder

A

Factor associated with the exposure and is independently a risk factor for a disease

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13
Q

How do we do randomisation?

A

3rd party

Computer generated random allocation

Accessed by phone/ internet

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14
Q

What is ‘knowing the treatment allocation’?

A

Knowledge of which participant is receiving which treatment - may bias result of clinical trial

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15
Q

What is behaviour effect?

A

Patient may alter their behaviour, other treatment, or expectation of outcome

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16
Q

What is non-treatment effect?

A

Clinician may alter their treatment, care and interest in the patient

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17
Q

What is measurement bias?

A

Investigator may alter their approach when making measurements and assessing outcomes

18
Q

What is blinding?

A

Follow-up participants in identical ways

19
Q

What is single, double, triple blind?

A

Single = One of patient, clinician, assessor does not know the treatment allocation

Double = 2 of patient, clinician, assessor does not know the treatment allocation

Triple = all do not know allocation

20
Q

What is advantage of blinding?

A

Minimise bias

Make treatment appear identical in every way

21
Q

What is bias?

A

Systematic distortion in allocation, measurement, or other forms (e.g. publication bias)

22
Q

How do we protect against confounding?

A

Randomisation

23
Q

How do we protect against bias?

A

Good randomisation - eliminates selection bias

Blinding - reduce outcome measurement bias

24
Q

Who should take part in a clinical trial?

A

All ages, sexes

Healthy volunteers

Those at increased risk

25
Q

Who should not take part in clinical trial?

A

Confirmed or suspected immunosuppressive etc.

Significant disease, disorder, or finding

26
Q

How do we consider ‘outcome measures’?

A

Pre-define outcomes
Primary and secondary outcomes
Types of outcomes
Features of an ideal outcome
Timing of measurements

27
Q

Why do we pre-define outcomes?

A
28
Q

What are the types of outcomes?

A
29
Q

What are the features of an ideal outcome?

A
30
Q

How do we show comparability between groups?

A

Ensure groups compared are as equivalent as possible

Collect baseline data on characteristics we think may relate to both the condition and outcomes

31
Q

What is ‘placebo effect’?

A

Even if therapy is irrelevant to a patient’s condition, their attitude/ illness may be improved by a feeling that something is being done about it

32
Q

What is a placebo?

A

Inert substance made to appear identical in every way to the active formulation with which it is being compared

33
Q

What is the aim of a placebo?

A

Cancel out any placebo effect

34
Q

How do we deal with ‘losses to follow-up’?

A

Make follow-up practical and minimise inconvenience

Be honest about commitment required

Avoid coercion or inducements

Recompense participants for their time/ trouble

Maintain contact

35
Q

How do we minimise non-adherence?

A

Simplify instructions

Ask about adherence

Ask about effects and side-effects

Monitor adherence, e.g. tablet control

36
Q

What is an explanatory trial?

A

As-treated analysis

Analyses only those who completed follow-up and adhered to treatment

37
Q

What is a pragmatic trial?

A

Intention-to-treat analysis

Analyses according to the original allocation to treatment groups

Compares likely effect of using treatments in routine clinical practice

38
Q

Compare explanatory vs. Pragmatic trials

A

Explanatory: loses effect of randomisation
Larger sizes of effect

Pragmatic: preserves effect of randomisation
More realistic sizes of effect

39
Q

What are the steps involved in a RCT

A

1) set up

2) conduct of trial

3) analysis and comparison of outcomes

40
Q

Describe the set-up of a RCT

A

Disease of interest

Treatments to be compared

Patients eligible for the trial

Patients to be excluded from the trial

Design questions: allocation (randomisation), blinding

Outcomes to be measures

41
Q

Describe the conduct of a RCT

A

Identify and invite of eligible patients

Consent patients

Allocate participants to treatments fairly

Follow-up participants in identical ways

Minimise losses to follow-up

Maximise adherence with treatments

42
Q

Describe the analysis of RCT

A

Compare the outcomes fairly intention to treat

  • is there an observed difference in outcome between treatment groups?
  • could this have arisen by chance?
  • how big is it?
  • is this attributable to treatments compared in the trial?

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