Course 1 Final Quiz

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Question 1 of 6

1. Question

Which of the following are TRUE regarding randomisation in the context of a clinical trial?

A. A randomized controlled trial is a type of medical experiment which aims to reduce bias when testing a new treatment.
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B. Randomised control trials allow researchers to guarantee that the study will be free of bias.
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C. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control.
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D. For safety reasons, participants in a randomised control trial are able to decide if they prefer to be in the treatment arm or the placebo arm.
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Question 2 of 6

2. Question

Which of the following are advantages of randomisation?

A. Randomisation will result in the different groups of patients in the study being comparable with regard to prognostic factors
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B. Randomisation renders the groups comparable not only in respect of known prognostic factors, but also with regard to unknown factors, e.g., genetic factors, that might affect the outcome.
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C. Thanks to block randomisation, the allocation of participants may be predictable and result in selection bias when the study groups are unmasked
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D. Randomisation requires clinical equipoise: one cannot ethically randomise patients unless both treatments have equal support in the clinical community
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Question 3 of 6

3. Question

Which of the following could be considered an adverse event?

A. Any reactions that are predictable from the drug's known pharmacology and are usually dose dependent
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B. Any unintentional complications resulting from the care provided
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C. Any unwelcome medical occurrence during a treatment with a pharmaceutical product, however not necessarily presenting a causing relation to the treatment
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D. Any allergic episode for example if a patient using a certain drug presents an allergy, it does not imply that it is resulting from the use of the drug
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E. Any consequence of the drug's primary pharmacological effect
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Question 4 of 6

4. Question

Which of the follow are considered adverse drug reactions?

A. Any reactions that are predictable from the drug's known pharmacology and are usually dose dependent.
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B. Nausea caused by a medication used to treat a heart condition.
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C. Any injury caused by taking a medication.
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D. Any injury that arises during a treatment.
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E. Any response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
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Question 5 of 6

5. Question

Which of the following are true about blinding in a clinical trial?

A. Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatment arms participants have been assigned
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B. In a Single Blind trial, only the patient knows in which treatment arm they have been assigned, the investigator does not know.
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C. In a Double Blind trial, only the investigator knows to which treatment are the patient has been assigned, the patient and the drug manufacturer do not know.
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D. Blinding is an important aspect of any trial done in order to avoid and prevent conscious or unconscious bias in the design and execution of a clinical trial.
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Question 6 of 6

6. Question

Which of the following is FALSE regarding surrogate endpoints as opposed to hard clinical endpoints?

A. No surrogate endpoint perfectly substitutes for a clinical endpoint.
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B. All surrogate endpoints are biomarkers.
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C. Not all biomarkers are useful surrogate endpoints.
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D. The way in which surrogate endpoints are used is critical and the science behind their selection must be rigorous.
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E. The validity of a useful surrogate endpoint marker depends greatly on the definition of the clinical efficacy measure.
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Eurordis - Rare Disease Europe

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