QuestionSBA
QuestionChoice
This is when trial participants believe that everything that happens in a research trial is for their own benefit, rather than realising the goal is to produce data. While important to minimise, this is not the concept the question is referring to.
10017330
e
Therapeutic misconception
QuestionChoice
This is the assumption that there is not one 'better' intervention present (for either the control or experimental group) during a trial. If there is no genuine uncertainty in whether one intervention is better/worse than another, then a trial should not be conducted.
10017326
a
Clinical equipoise
QuestionChoice
This is not an established ethical principle. The issue with this trial is that the ethics committee believe there is no genuine clinical equipoise. A non-inferiority trial is one that attempts to show that an intervention is not worse (but also not necessarily better) than another.
10017329
d
Non-inferiority
QuestionChoice
This is not an established ethical principle. The issue with this trial is that the ethics committee believe there is no genuine clinical equipoise.
10017327
b
Proof of effect
QuestionChoice
All trials require participants (or their proxies) to consent, in accordance with the Declaration of Helsinki. However, this is not the ethical principle that the committee are concerned about.
10017328
c
Informed consent
QuestionComment
I read this question 10 times and still did not get it right :(
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CT Position
QuestionComment
thanks, son's crying
43888
User
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AarohToTheKnee
QuestionComment
This question was basically Liverpool (A)
61439
User
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Gabriel Magalhaes
Concept
Chapter
# Uses

Randomised controlled trials are useful to determine whether a cause-effect relationship exists between treatment and outcome. They can also be used to assess the cost-effectiveness of a treatment.

# Important features of randomised controlled trials

- Random allocation to intervention groups
- Patients and trialists should remain unaware of which treatment was given until the study is completed-although such **double blind** studies are not always feasible or appropriate
- All intervention groups are treated identically except for the experimental treatment
- Patients are normally analysed within the group to which they were allocated, irrespective of whether they experienced the intended intervention (intention to treat analysis)
- The analysis is focused on estimating the size of the difference in predefined outcomes between intervention groups.

# Improving RCT value 

**Increasing the strength of RCTs using meta-analyses**

To strengthen the evidence further, a meta-analysis of RCTs investigating the same intervention can be conducted.

Meta-analyses enable the combining of data from multiple studies to derive conclusions based on the application of objective formulas to the combined data.

In this way, meta-analyses increase the statistical power and enable a more accurate assessment of the validity of a hypothesis than can be achieved by a single study.
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Properties of Randomised Controlled Trials
Topic
51
Medical Statistics
16009
Clinical equipoise refers to a genuine uncertainty or balance of opinion within the medical community about the relative benefits and risks of two or more treatment options, which justifies conducting a clinical trial to determine which treatment is more effective.
A  medication is being studied for the treatment of lung cancer. An ethics committee does not approve a randomised controlled trial of the medication, as they do not believe there is genuine uncertainty about whether the current standard of care is better or worse than this new medication.

What best describes the ethical concept the investigators are referring to?
a