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CPT (My own) > 1.3 Clinical Trials > Flashcards

1.3 Clinical Trials Flashcards

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1
Q

Definition of a clinical trial

A

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

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2
Q

What is the purpose of a clinical trial?

A

To provide reliable evidence of treatment and efficacy and safety

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3
Q

Define efficacy

A

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

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5
Q

Efficacy vs effectiveness

A

Efficacy- measured in ideal clinical conditions, mostly used by pharmaceutical companies
Effectiveness- real world clinical experience, more significant for clinicians

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6
Q

What 3 things does a clinical trial need to be? And why?

A

Reproducible
Controlled- so that the effects of the new treatment are isolated and can confirm the outcomes are down to the treatment
Fair- unbiased

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7
Q

What are the stages of drug development?

A

Preclinical -> 1. Volunteer studies –> 2. Treatment studies –> 3. Clinical trials –> 4. Post marketing surveillance

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8
Q

Explain the disadvantages of comparison with historical controls

A

Selection often less well defines
Less info available about potential bias or confounders
Lack of control of the other treatments provided by the hospital
Hospital care changes with time
Populations change with time

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9
Q

Explain the disadvantages of non randomised clinical trials

A

Allocation bias and confounding variables
Hospital management might be different
Populations might be varying e.g. ethnicity

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10
Q

Outline the steps involved in a randomised controlled trial

A

Definition of key study variables
Conduct of the trial
Comparison of the outcomes

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11
Q

RCT: step 1 Define

A

Define:
The disease of interest and which patients would be eligible
Which treatments are being compared e.g. 2 drugs or vs a placebo
What outcomes are being measures
Are there any possible biases or confounders

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12
Q

RCT: Step 2 Conduct of the trial

A

Identify and invite a source of eligible patients with consent
Allocate patients fairly
Follow up in identical ways
Minimise losses to follow up and maximise adherence

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13
Q

RCT Step 3 Comparison of outcomes

A

Statistically significant? CLincially significant? Good design?

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14
Q

Why do we need to have ore-defining outcomes?

A

It prevents data dredging and repeating analyses, it is protocol for data collection and have agreed criteria

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15
Q

What is the difference between primary and secondary outcomes?

A

Primary- used in the sample size calculation and tends to be mortality. Mortality is the most common used by companies
Secondary- Eg QOL, ejection fraction

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16
Q

Types of outcomes

A

Patho-physiological e.g. tumour size, thyroxine levels
Clinical e.g. death, disease, disability
Patient focused e.g. QoL, psychological well-being, social well-being, satisfaction

17
Q

Features of an ideal outcomes

A 
Appropriate and relevant
Valid and attributable 
Sensitive and specific 
Reliable and robust
Simple and sustainable 
Cheap and timely
18
Q

What does random allocation allow?

A

Minimal allocation bias and minimal confounding variable, works for known and unknown variables

19
Q

What is a confounder?

A

A confounder is a factor associated with the exposure and is independently a risk factor of the disease

20
Q

What are the most common confounding variables

A

Age and sex

21
Q

What effect can knowing the treatment allocation have on the trial? How does it effect the three parties of the trial?

A

May bias the results.
Patients- behaviour effect
Clinician- non treatment effect
Investigator- measurement bias

22
Q

How can we avoid allocating bias?

A

Blinded trials

23
Q

Describe the placebo effect

A

Even if the therapy is irrelevant to the patients condition, the patients attitude to his or her illness, and indeed the illness itself, may be imoirced by a feeling that something is being done about it.

24
Q

What is a placebo, what is its function?

A

An inert substance made to appear identical to treatment which it is compared to.
The aim is to cancel out placebo effect

25
Q

What are the ethical implications of a placebo?

A

It should only be used in the absence of standard treatment
Use of a placebo is a form of deception
Therefore patients must be informed they may be receiving a placebo

26
Q

How does one overcome losses to follow up?

A

Make the follow up practical and minimise inconvenience
Be clear and honest about the commitment required from participants
Avoid coercion or inducements
Maintain contact with patients

27
Q

How does one overcome non-compliance with treatments

A

Simplify the instructions
Ask abut compiance
Ask about effects and side effects

28
Q

What are reasons for non-compliance?

A 
May have misunderstood instructi9ons
May not like their treatment
May think their treatment is not working
May switch to other treatment
Cant be bothered
29
Q

What is an explanatory trial also known as?

A

‘As treated’ analysis

30
Q

Describe explanatory trials:

A

Analyses only those who completed the follow up and complied with treatment and compares the physiological effects of the treatments

31
Q

What is the disadvantage of explanatory trials

A

Loses the effects on randomisation as the non compilers are likely to be systematically different to the compliers so there is selection bias and confounding

32
Q

What is a pragmatic trial also known as?

A

Intention to treat analysis

33
Q

Describe pragmatic trials

A

Analyses according to the original allocation to treatment groups regardless of compliance or follow pu and compares the likely effects of using treatment in routine clinical practice
PRESERVES RANDOMISATION

34
Q

‘As treated’ vs ‘Intention to treat’

A

As treated analyses tend tp give larger sizes of effect

Intenti0on to treat analyses tend to give snakier and fire realistic size of effect- this is the preferred option

35
Q

Declaration of Helsinki 2013

A

“The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

36
Q

What is collective ethic?

A

All patients should have treatments that are properly tested for efficacy and safety

37
Q

What is individual ethic?

A

Beneficiance
Non Maleficience
Autonomy
Justice

38
Q

What are the issues that should be considered for a clinical trial to be ethical?

A

Clinical equipoise- when there is reasonable uncertainty to genuine ignorance about the better treatment or intervention
Scientifically robust- addresses the question
Ethical recruitment
Valid consent
Voluntariness

CPT (My own) (6 decks)

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