Pharmacy AI · Module 5 · Unit 1 · Practical 1 — Clinical Trials in Pharmacy

Clinical Trial Phase Identification Challenge

Aim — To differentiate between Phase I, II, III and IV clinical trials using real-life case scenarios, and to justify the identification from the study objective, the participants and the sample size. Duration 45 minutes · 10 randomised scenarios · 20-mark rubric per scenario · Pass 50%.

Scenario —

Score —

Result —

Time 00:00

Best —

◐ Theme

New to clinical trial phases? Start here

A new medicine climbs a ladder of four phases. Each phase answers one question, and each exposes more people to the drug only after the previous phase showed acceptable risk. To identify a phase, ask in this order:

Is the drug already approved and marketed? If yes → Phase IV (post-marketing surveillance), whatever the size.
Who is being studied? Healthy volunteers → Phase I. Patients with the disease → Phase II or III.
Is it compared against an existing standard treatment or placebo for registration? → Phase III.
Is it finding whether it works and at what dose, in a few hundred patients? → Phase II.

Use the sample size only as a cross-check — never as your first clue. Unsure on a scenario? Open “Need a hint?” in the station.

Student tasks

Clinical trial phases at a glance

Phase	Main objective	Participants	Typical number
Phase I	Safety, tolerability & pharmacokinetics; dose escalation to find the maximum tolerated dose	Healthy volunteers (patients in oncology / cytotoxic studies)	20–100
Phase II	Efficacy (proof of concept) and the optimal dose; further safety	Patients with the target disease	100–300
Phase III	Comparison with the existing standard treatment or placebo; confirms efficacy for regulatory approval	Patients — large, multicentre, randomised	1,000–5,000
Phase IV	Post-marketing surveillance — rare and long-term adverse effects in real-world use	General population using the marketed drug	Tens of thousands

Watch the exception: a first-in-human study of a cytotoxic or oncology drug recruits patients rather than healthy volunteers — but it is still Phase I.

Faculty assessment rubric

Criteria	Marks

Each scenario is auto-scored out of 20 and converted to a percentage. Justification combines the sample-size estimate (3) with your written clinical justification (2). Pass mark 50%.

Candidate & scenario assignment

Candidate name

Registration no.

Assigned scenario

Ten scenarios cover all four phases. Your faculty may assign one, or randomise for practice.

Practical record & assessment

Complete the challenge station and submit to generate your assessment, then write and submit your report.