Loading…

BioPlayground

🧬
Bio-Toolkit

Clinical Sample Size Calculator

Clinical trial sample size + power calculator (6 designs + 3 hypothesis types + 2D sensitivity matrix)

n = (z_{1−α/2} + z_{1−β})²·σ²/Δ² ; d = (μ₁−μ₂)/σ ; events = (k+1)²·(z_α+z_β)²/[k·(ln HR)²]

임상시험 표본수 계산기

6 디자인 × 3 가설 (Superiority / Non-inferiority / Equivalence TOST) + 2D 민감도 매트릭스 (G*Power 웹 대체)

통계 디자인 선택

가설 유형

Effect Size Workspace

Direct ParameterCohen's d
Small: 0.2Medium: 0.5Large: 0.8현재: 중간
Raw Helper (실시간 동기화)

Helper 선택 시 raw parameter → effect size 자동 변환 (버튼 X, 실시간 양방향 동기화).

검정 변수

계산 결과

그룹당 n

64

총 N

128

달성 검정력

80.1%

임계값

1.9790

α (실효)

0.05

검정 sides

2

검정력 곡선 (Power Curve)80% 목표n = 64그룹당 표본 크기 (n)검정력 (1 − β)0.000.250.500.751.00
-20%-10%0%10%20%75%80%85%90%95%민감도 매트릭스 (Y: Effect Size Δ × X: Power)N=176Power: 75% | ES: 0.400 (Δ -20%) | N: 176N=200Power: 80% | ES: 0.400 (Δ -20%) | N: 200N=228Power: 85% | ES: 0.400 (Δ -20%) | N: 228N=266Power: 90% | ES: 0.400 (Δ -20%) | N: 266N=330Power: 95% | ES: 0.400 (Δ -20%) | N: 330N=140Power: 75% | ES: 0.450 (Δ -10%) | N: 140N=158Power: 80% | ES: 0.450 (Δ -10%) | N: 158N=180Power: 85% | ES: 0.450 (Δ -10%) | N: 180N=212Power: 90% | ES: 0.450 (Δ -10%) | N: 212N=262Power: 95% | ES: 0.450 (Δ -10%) | N: 262N=114Power: 75% | ES: 0.500 (Δ 0%) | N: 114N=128Power: 80% | ES: 0.500 (Δ 0%) | N: 128N=146Power: 85% | ES: 0.500 (Δ 0%) | N: 146N=172Power: 90% | ES: 0.500 (Δ 0%) | N: 172N=212Power: 95% | ES: 0.500 (Δ 0%) | N: 212N=94Power: 75% | ES: 0.550 (Δ 10%) | N: 94N=106Power: 80% | ES: 0.550 (Δ 10%) | N: 106N=122Power: 85% | ES: 0.550 (Δ 10%) | N: 122N=142Power: 90% | ES: 0.550 (Δ 10%) | N: 142N=174Power: 95% | ES: 0.550 (Δ 10%) | N: 174N=80Power: 75% | ES: 0.600 (Δ 20%) | N: 80N=90Power: 80% | ES: 0.600 (Δ 20%) | N: 90N=102Power: 85% | ES: 0.600 (Δ 20%) | N: 102N=120Power: 90% | ES: 0.600 (Δ 20%) | N: 120N=148Power: 95% | ES: 0.600 (Δ 20%) | N: 148권장 임상 충족 영역 (Power ≥ 80%)Power 미달

CONSORT 2010 §7a 표본수 정당화 문구

Sample Size Justification (CONSORT 2010 §7a)

An a priori sample size estimation was conducted for a Two-sample t test (superiority hypothesis). The total sample size of N = 128 subjects provides 80.1% power to detect an effect size of 0.500 at a two-sided significance level α = 0.05. The calculation employed central and non-central distribution functions (Acklam 2003 normal inverse, Numerical Recipes 2e §6.4 Lentz CF incomplete beta, Lenth 1989 non-central t / Poisson-weighted F / chi² series — Patnaik 1949 approximation excluded per Cross-Check Report §1.2).

Tool Guide

Definition

The Clinical Sample Size Calculator computes any one of {α, power, effect size, sample size} when the other three are provided. It supports six statistical designs (one-sample t / two-sample t / paired t / one-way ANOVA / chi² two-proportion / McNemar paired / log-rank survival) and three hypothesis types (superiority / non-inferiority / equivalence TOST). The engine is 100% self-implemented with zero external statistics libraries (Acklam 2003 inverse normal + Numerical Recipes 2e §6.4 Lentz CF incomplete beta + Lenth 1989 non-central t + Poisson-weighted non-central F/χ² direct summation — Patnaik 1949 approximation excluded per Cross-Check Report §1.2), validated against G*Power Manual T1-T5 (n=64 / N=180 / N=108 / N≈117 / events=247).

Purpose

(1) Alternative to G*Power (Windows/Mac desktop, English-only), PASS NCSS (annual six-figure license), and nQuery (CRO license) — instant web + Korean + mobile (2) Low barrier to entry for clinical statistics / CRA / public-health MS/PhD students (no more R `pwr` coding overhead) (3) Built-in FDA / EMA / MFDS regulatory baselines (Context-Aware Smart Defaults: Superiority two-sided α=0.05 / NI one-sided α=0.025 auto-locked with Sides disabled / Equivalence TOST one-sided α=0.05 parallel on both sides) (4) Auto-generated CONSORT 2010 §7a sample size justification English template — copy directly into IRB / IND submissions

How to Use

① Pick design (6 cards: one-sample / two-sample / paired t / ANOVA / chi² / McNemar / log-rank) ② Pick hypothesis (Superiority / Non-inferiority / Equivalence TOST) • NI auto-enforces α=0.025 one-sided + Sides disabled lock (FDA 2016 / MFDS 2018 guidance) • Equivalence enforces one-sided α=0.05 on each side (95% CI = two-sided α=0.10) with auto info panel ③ Enter effect size — Split-Screen Workspace: • Left: Direct Parameter (d / f / w / h / OR / HR) + Cohen 1988 S/M/L benchmarks • Right: Raw Helper (μ₁/μ₂/σ → d / p₁/p₂ → h / OR → d / HR → ln HR) — real-time bidirectional sync (no apply button) ④ Enter α / power / allocation ratio / number of multiple tests ⑤ Auto-computes: n per group / total N / achieved power / critical value + design-specific (ANOVA k / chi² df / McNemar ψ·p_d / log-rank HR·P_event·dropout) ⑥ Visualizations: Power Curve (custom SVG, 80% target dashed line + current N marker) + **2D Sensitivity Matrix Heatmap** (5×5 grid, Power ≥ 80% Regulatory Compliant Zone emerald border) ⑦ Export: PNG (heatmap) / CSV (input + result + 25 cells) / JSON (full state) + **One-click copy of CONSORT 2010 §7a sample size justification English template**

Examples

Example 1) Two-sample t-test (G*Power Manual §3 / §11.2) → Cohen's d = 0.5, α = 0.05 (two-sided), power = 0.80, 1:1 → **n_per_group = 64, total N = 128** Example 2) One-way ANOVA (G*Power Manual §4 / §10.3) → Cohen's f = 0.25, α = 0.05, power = 0.80, k = 4 groups → **N = 180** Example 3) Chi² two-proportion (Cohen 1988 Table 7.4.4) → Cohen's w = 0.3, df = 1, α = 0.05, power = 0.80 → **N = 108** Example 4) McNemar paired (Connor 1987 Table 1) → Odds Ratio ψ = 2.0, p_discordant = 0.30, α = 0.05, power = 0.80 → **N ≈ 117 pairs** Example 5) Schoenfeld log-rank (Schoenfeld 1981 / CWS §7.2) → HR = 0.7, α = 0.05 (two-sided), power = 0.80, 1:1 → **events d = 247** → P_event = 0.7 → N ≈ 353; 10% dropout adjustment → N ≈ 393 Example 6) Non-inferiority (FDA NI 2016 §IV.A) → Switch hypothesis to NI → α = 0.025 one-sided auto-enforced → info panel shown

🧬BioArxComing Soon

AI platform for biomedical researchers. From gene therapy design to paper analysis.

www.bioarx.com →

🔗 Bio Resources

🔬NCBI PubMed🧪AlphaFold DB🏥ClinicalTrials.gov📄bioRxiv🚀ASGCT🏛️Broad Institute

AD

AD Inquiries: bioplayground.official@gmail.com

Notice

BioPlayground is in beta. Feedback is always welcome! 🧬

Menu

Bio-LoungeResearchers' rest area
Bio NewsLatest research trends
Bio IndustryGlobal Biotech Industry Insights
AI NEWSToday's essential AI stories
Bio-ToolkitFrom sequence conversion to calculations
AI ToolsAI tools for bio researchers
Tools HubGeneral utility tools
ProtocolCoreFrom paper evidence to your own protocol
Disease AtlasEvidence-based disease guides
Bio-SandboxSpace for indie developers
WetBenchNobel Prizes, protocols, informatics
DryBenchCoding, CS logic, data processing
DevBenchBio Coding Education
Failure MuseumFailed experiment records
Healing LabComfort and empathy space
Trouble LabLab troubleshooting Q&A
Lab OracleFortune and astrology
ArcadeShort puzzle breaks between research
💬
Lounge TalkOpen community discussion
🔧
Lab MaintenanceSite suggestions and bug reports
Language HubLearn languages (KO ↔ EN)
⚠️

Peer Review Warning

No Target

🚫

Suspended Researchers

No Target

📄 About BioPlayground