termsTerm

Blinded trial

aka blinded, double-blind, double-blinded, double blind, single-blind, open-label, open label, unblinded, unblinding, blinded review, blinded independent review

Keeping patients (single-blind) or patients and doctors (double-blind) from knowing who is on which treatment, so that hopes and expectations cannot colour the results.

Blinding protects outcomes that involve judgement: how a patient rates their symptoms, whether a doctor decides a scan shows progression, or when to stop treatment; hard outcomes such as death are less vulnerable. Many cancer trials are open-label because the treatments are too different to disguise (an infusion versus a tablet, distinctive side effects), and they compensate by having scans read by a blinded independent central review (BICR) and by using overall survival, which cannot be biased by knowing the assignment. Unblinding a trial early, for example at an interim analysis, is a formal step overseen by an independent data monitoring committee.

Connected

5top

Pages like this

not linked directly; found by shared links

Term
Phase 1, 2 and 3 trials
Shares Randomised trial, Clinical trial, Endpoint.
Term
P-value
Shares Randomised trial, Endpoint.
Term
Confidence interval
Shares Randomised trial, Endpoint.
Term
Standard of care
Shares Placebo, Randomised trial, Clinical trial.
Term
Hazard ratio (HR)
Shares Randomised trial, Endpoint.
Term
Objective response rate (ORR)
Shares Blinded independent central review (BICR), Endpoint.

terms

Blinded independent central review (BICR)Clinical trial Endpoint Placebo Randomised trial