Blinding (double-blind, open-label, placebo-controlled)
Whether patients and doctors know which treatment is being given. Double-blind: neither knows (a placebo hides it). Open-label: both do, unavoidable for surgery or radiotherapy but a source of bias when judging progression and symptoms.
Blinding protects subjective outcomes (progression on scans, symptom scores, decisions to stop or switch) from expectation bias. Many oncology trials are open-label because the comparators differ in route or schedule; they compensate with blinded independent central review of imaging and hard endpoints such as overall survival. Placebo-controlled designs are standard for maintenance and adjuvant trials (adding a pill or nothing). Unblinding at interim analysis, or effective unblinding through side effects (alopecia, rash), can compromise a trial, and open-label designs tend to show larger investigator-assessed PFS effects than blinded review.
Pages like this
not linked directly; found by shared links- TermNon-inferiority trial
Shares Intention-to-treat (ITT) and per-protocol analysis, Control arm and comparator (investigator's choice).
- TermExternal and synthetic control arms
Shares Single-arm trial, Control arm and comparator (investigator's choice).
- TermObjective response rate (ORR)
Shares Blinded independent central review (BICR), Single-arm trial.