Epidemiology: phase III trial: practice question

A PSM question in the style of the NEET PG paper. Answer it first, then read why the right option is right and why each of the others is wrong.

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PSM · Epidemiology: phase III trial

Sample item

A new antidiabetic drug that has shown acceptable safety and some effect in earlier studies is now compared with standard therapy in a large multicentre randomised trial of several thousand patients, mainly to confirm efficacy and detect adverse effects before licensing. Which phase is this?

Original practice item, not a recalled exam question. Nothing here is recorded.

The answer and the reasoning

A. Phase III

Phase III trials are large randomised comparisons with standard treatment that confirm efficacy and monitor adverse effects, and their results support a licensing application. Phase I tests safety and dose in a few volunteers, phase II tests efficacy in a limited patient group, and phase IV is post-marketing surveillance.

Option by option

  • A. Phase III (correct)

    Correct. A large randomised comparison with standard care before licensing is phase III.

  • B. Phase IV

    Phase IV occurs after marketing to detect rare adverse effects.

  • C. Phase II

    Phase II studies efficacy and dose in a limited number of patients.

  • D. Phase I

    Phase I involves a small number of volunteers to study safety and dose.

Source note: Original NextPrep sample item — pending expert review. This item is original practice material awaiting independent expert review, so confirm important facts in a standard textbook.

More PSM questions

Questions about this PSM question

What is the answer to this PSM question?

The best answer is A, Phase III. Phase III trials are large randomised comparisons with standard treatment that confirm efficacy and monitor adverse effects, and their results support a licensing application.

Why is "Phase IV" not the answer?

Phase IV occurs after marketing to detect rare adverse effects.

Why is "Phase II" not the answer?

Phase II studies efficacy and dose in a limited number of patients.

Why is "Phase I" not the answer?

Phase I involves a small number of volunteers to study safety and dose.

What concept does this question test?

It tests Epidemiology: phase III trial in PSM. Phase I tests safety and dose in a few volunteers, phase II tests efficacy in a limited patient group, and phase IV is post-marketing surveillance.

How hard is this question?

We tag it as an application question: it asks you to use a fact on a patient or a finding. The tag is our own editorial judgement, not an official difficulty rating, so read the reason for every option, not only the answer.

How should I study Epidemiology: phase III trial?

Practise biostatistics with small calculations until sensitivity, predictive values and risk measures are automatic. Then use the flashcards and the other PSM questions on this site to test what stuck.

Is this a real NEET PG question?

No. It is an original practice item (editorial status: sample, version 1). NextPrep does not publish recalled or leaked questions, and independent faculty review of this item has not been completed yet, so confirm important facts in a standard textbook.