Chapter 19 MCQs

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. Which of the following would be exclusion criteria for a clinical trial for the use of apixaban for treatment of atrial fibrillation (AF)?

AF at the time of enrolment correct incorrect

Severe renal insufficiency correct incorrect

At least 75 years old correct incorrect

Hypertension requiring drug treatment correct incorrect

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. Which of the following types of disorder does NOT need to be taken into account in the design of a clinical trial?

Acute correct incorrect

Chronic correct incorrect

Irregular correct incorrect

Cyclical correct incorrect

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. Which of the following is NOT a requirement of a well-controlled clinical trial?

Elimination of bias correct incorrect

Minimisation of variability correct incorrect

Reliability of the outcome correct incorrect

Comparison with a known active comparator correct incorrect

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. Which of the following is NOT a recognised randomization technique?

Restrictive simple randomization correct incorrect

Unrestricted simple randomization correct incorrect

Non-adaptive randomization correct incorrect

Alternative randomization correct incorrect

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. Which one of the following definitions of the types of blinding used in clinical trials is INCORRECT?

Open label—no parties are aware of the treatment the participant is receiving. correct incorrect

Single-blinded—only one party is unaware of the treatment the participant is receiving. correct incorrect

Double-blinded—the participants and the investigators are unaware of the treatment the participant is receiving. correct incorrect

Triple-blinded—participants, investigators and data analysts are unaware of the treatment the participant is receiving. correct incorrect

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. Which of the following is NOT a significant type of clinical trial design?

Comparative correct incorrect

Cross-over correct incorrect

Parallel group correct incorrect

Non-comparative correct incorrect

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. Which of the following potential ethical issues may NOT cause a problem for a clinical trial?

Lack of informed consent correct incorrect

Outsourcing to other countries correct incorrect

Placebo usage correct incorrect

Randomization correct incorrect

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. Which of the following is NOT necessary for inclusion in a clinical report form?

Inclusion/exclusion criteria correct incorrect

Adverse events correct incorrect

Type of blinding correct incorrect

Withdrawal of participants correct incorrect

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. Which analytical aspect is NOT included in a clinical study report (CSR)?

Detailed statistical analysis correct incorrect

Analysis of outcomes not in the trial protocol correct incorrect

Justification for use of non-standard analytical techniques correct incorrect

Ability to repeat any statistical manipulation used correct incorrect

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. Which of the following is NOT a challenge to the current organization of clinical trials?

Personalised medicines correct incorrect

Complex disease mechanisms correct incorrect

Changes in regulations correct incorrect

Recruitment and retention of participants correct incorrect