Statistics Quest

Applied case · Healthcare and clinical research · about 80 minutes

Evaluating a (fictional) blood-pressure trial

Analyse a randomised, placebo-controlled trial end to end: check the randomisation and the dropouts, choose the comparison that actually estimates the drug effect, quantify it with an interval and effect size, and weigh it against adverse events.

The brief

A small (fictional) pharmaceutical developer ran an 8-week randomised, double-blind trial of an antihypertensive tablet against placebo in 200 adults whose systolic blood pressure (SBP) was at least 140 mmHg at screening, across three clinics. The independent statistician's report goes to the steering committee, which must decide whether the results justify a larger, longer confirmatory trial — a commitment of several million riyals.

The pre-specified primary outcome is the change in SBP from baseline to week 8, compared between arms. The committee also wants to know about adverse events and about the 19 participants who left before week 8.

Scenario assumption. The (fictional) protocol states that a between-arm difference of at least 5 mmHg in SBP change would be worth confirming in a larger trial. That number is part of this exercise, not a clinical guideline: in real trials, what counts as a clinically meaningful change is set by clinicians and guidelines for the specific outcome and patient population, not by the statistician.

Your data: bp_trial (synthetic), one row per participant: clinic, arm, age, sex, baseline and week-8 SBP, adverse-event flag and dropout flag.

This trial, its drug, clinics and participants are entirely fictional. Nothing here is medical evidence or advice.

Dataset

Blood-pressure drug trial (fictional)

200 rows · one row = one trial participant · synthetic data

ParticipantClinicArmAge (years)SexBaseline SBP (mmHg)Week-8 SBP (mmHg)Adverse eventDropped out
P001Clinic 1Treatment56Female158146falsefalse
P002Clinic 2Placebo80Male152139falsefalse
P003Clinic 3Placebo63Female177missingfalsetrue
P004Clinic 1Treatment51Male153142falsefalse
P005Clinic 2Placebo50Female167157falsefalse
P006Clinic 3Treatment55Male154144falsefalse

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This case has 4 stages and 9 graded tasks, ending with a written report.

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