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CPT > Clinical Trials > Flashcards

Clinical Trials Flashcards

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1
Q

What is the purpose of a clinical trial?

A

To provide reliable evidence of treatment efficacy + safety

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2
Q

Define clinical trial

A

Any form of planned experiment which involves patients and is designed to elucidate the most appropriate method of treatment for further patients with a given medical condition

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3
Q

What are the stages in drug development?
What are they testing

A
  • pre-clincal phase: lab studies on cultures + animals | toxicity
  • phase 1: volunteer studies | major side effects, pharmacodynamics + pharmacokinetics| < 100 healthy volunteers
  • phase 2: treatment studies | dosage + common side effects <1,000 patients
  • phase 3: clinical trials | comparison | <10,000 patients
  • phase 4: post marketing surveillance | monitor for adverse reactions + new uses
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4
Q

Describe key ethical considerations in trial design + conduct

A
  • trials of new drugs may do harm
  • patient must give informed consent
  • trial must only be conducted if in clinical equipoise
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5
Q

Advantages of using random allocation to minimise confounding

A

Randomisation leads to treatment groups that are likely to be similar in size + characteristics

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6
Q

What is clinical equipoise?

A

The assumption that there is not one better intervention present during design of randomised controlled trial

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7
Q

Disadvantages of using historical control group in non randomised trial

A
  • selection often less well defined
  • treated differently from new group
  • may be less information about possible bias
  • unable to control for confounders
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8
Q

What is a confounder?

A

A third factor that is associated with the exposure + the outcome which distorts the relationship between them

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9
Q

Factors need of a clinical trial to give a fair comparison

A

Reproducible
Controlled
Fair

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10
Q

What does randomisation mean?

A

Whether a participant ends up in the treatment or comparison group is due to chance alone

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11
Q

What is single blind?

A

One of patient, clinician, assessor does not know which group the patient is in

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12
Q

What is double bind?

A

Two of patient, clinician, assessor does not know which group the patient is in

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13
Q

What is triple blind?

A

Everyone does not know which group a patient is in

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14
Q

Examples where blinding is difficult

A
  • surgical procedures
  • psychotherapy vs anti depressant
  • alternative medicine
  • lifestyle interventions
  • prevention programmes
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15
Q

Why is allocation concealment important in a randomised controlled trail?

A
  • Without it the recruiter may unconsciously affect who gets enrolled in the trail
  • prevents allocation bias (type of selection bias)
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16
Q

What is the purpose of allocation concealment

A

To hide the randomisation sequence from those recruiting people into the trail

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17
Q

Purpose of randomisation

A

Distributes confounders equally between groups

18
Q

What does randomisation prevent?

A

Confounding

19
Q

What is the purpose of blinding?

A

Makes patient, clinical and/or assessor unaware of treatment received

20
Q

What does blinding prevent?

A

Bias in how patients act, clinical treat patients or assessors measure outcomes

21
Q

What are the types of outcome?

A

Patho-physiological
Clinically defined
Patient-focused

22
Q

Features of an ideal outcome

A
  • appropriate + relevant
  • valid + attributable
  • sensitive + specific
  • reliable + robust
  • simple + sustainable
  • cheap + timely
23
Q

Reasons for pre-defining outcomes

A
  • prevent data dredging, repeated analyses
  • have a clear protocol for data collection
  • agreed criteria for measurement + assessment of outcomes
24
Q

What are pre defining outcomes?

A

Need to define what, when and how outcomes are to be measured before start of clinical trial

25
Q

What are primary outcomes?

A

Normally only one thing that you want to find out from the trial

26
Q

What are secondary outcomes?

A

Other outcomes of interest that are not your main point
e.g side effects

27
Q

What is the placebo effect?

A

Even if the therapy is irrelevant to the patients condition, the patients attitudes towards their illness + the illness itself may be improved by a feeling that something is being done

28
Q

What is a placebo?

A

An inert substance made to appear identical in every way to the active drug it’’s being compared to

29
Q

What are the ethical implications for placebo?

A
  • only used when no standard treatment is available
  • use of placebo is a form of deception
  • therefore, participants must be told that they may receive a placebo
30
Q

Why may not every patient remain in the trial?

A
  • clinical condition may necessitate their removal
  • choose to withdraw from trail
31
Q

How do you minimise losses to follow up?

A
  • make follow up practical + minimise inconvenience
  • be honest about commitment needed
  • avoid coercion
  • maintain contact with participant
32
Q

Why may participants not adhere to treatments?

A
  • misunderstanding instruction
  • not bothered to take treatment
  • may not like taking treatment
  • may not think it is working
  • may rather another treatment
33
Q

How can you maximise adherence to treatment?

A
  • simple instructions
  • ask about adherence
  • ask about side effects
  • monitor adherence
  • understand that you will never achieve 100* adherence
34
Q

What is the aim of a placebo?

A

To cancel out any placebo effect that may exist in the active treatment

35
Q

What type of analysis is an explanatory trial?

A

Per protocol analysis

36
Q

What type of analysis is a pragmatic trail?

A

Intention to treat

37
Q

Explain an explanatory trial

A
  • ‘per-protocol analysis’
  • analyse only those who completed follow up + adhered to treatments
  • compares physiological effects
  • but loses effects of randomisation > may introduce confounding
38
Q

Explain a pragmatic trail

A
  • ‘intention to treat’ analysis
  • analyses according to original allocation regardless of completion of follow up or adherence
  • compares likely effects of using treatments
  • AND preserves randomisation > minimise confounding + bias due to loss of follow up
39
Q

Key design features in clinical trails + purpose

A
  • should be reproducible, comparative + fair
  • randomisation: minimise confounding
  • concealing allocation sequence: minimise allocation bias
  • blinding: minimise performance + detection bias
  • *suitable outcome measures
  • minimise losses to follow up
  • maximise adherence
  • use intention to treat analysis
40
Q

Should you use per-protocol or intention to treat analysis in a RCT?
Why?

A

Intention to treat
Preserves randomisation > minimises confounding + bias sue to loss to follow up

CPT (29 decks)

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