Endpoint Library

Browse common clinical trial endpoints with typical effect sizes and references.

Overall Survival (OS)

OncologyPrimary

Time from randomization to death from any cause.

Typical Effect:HR 0.70–0.85

Typical Parameters:Median OS improvement of 2–6 months

ICH E9(R1), FDA Oncology Guidance

Progression-Free Survival (PFS)

OncologyPrimary

Time from randomization to disease progression or death.

Typical Effect:HR 0.50–0.75

Typical Parameters:Median PFS improvement of 3–8 months

EMA Anticancer Guideline

HbA1c Change from Baseline

DiabetesPrimary

Mean change in glycated hemoglobin from baseline to 24-26 weeks.

Typical Effect:Difference: -0.3% to -0.7%

Typical Parameters:SD typically 0.8–1.2%

FDA Guidance for Diabetes

ACR20/50/70 Response

RheumatologyPrimary

Proportion achieving 20/50/70% improvement in ACR criteria.

Typical Effect:Difference: 15–25% (ACR20)

Typical Parameters:Control rate: 25–40%

ACR Guidelines

MACE (Major Adverse Cardiovascular Events)

CardiologyPrimary

Composite of CV death, MI, and stroke.

Typical Effect:HR 0.80–0.90 (NI margin: 1.30)

Typical Parameters:Event rate: 3–5%/year

FDA CV Safety Guidance

Objective Response Rate (ORR)

OncologySecondary

Proportion with complete or partial tumor response per RECIST.

Typical Effect:Difference: 10–30%

Typical Parameters:Control rate varies widely

RECIST 1.1 Guidelines

FEV1 Change from Baseline

RespiratoryPrimary

Change in forced expiratory volume in 1 second.

Typical Effect:Difference: 100–200 mL

Typical Parameters:SD: 200–300 mL

ATS/ERS Standards

PANSS Total Score Change

PsychiatryPrimary

Change in Positive and Negative Syndrome Scale total score.

Typical Effect:Difference: 5–10 points

Typical Parameters:SD: 15–20 points

FDA Psychiatry Guidance