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4 changes: 1 addition & 3 deletions _sources/docs/Delta_part1.md
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#

# **DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial 리뷰**
# DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial part 1

https://lh4.googleusercontent.com/pno7K44oyUgCTg8M6IuAgTSCyqV_GWwY1Cx8Oky6SMjnzEgzQlLYdtP3wmXBmjnLOttizR_SfRkzN6T6mUumMsJDvsBlhFmfW8o0mZnuFJ8qiCD_57m-8NDlrzAEeStdHL64lusoLoBWIP7t1jdtHbk

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2 changes: 1 addition & 1 deletion _sources/docs/Diagnostic_part1.md
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#
# Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff part 1

**진단 검사를 평가하는 연구 결과의 보고에 대한 통계적 지침**

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2 changes: 1 addition & 1 deletion _sources/docs/Diagnostic_part2.md
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# ****Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff****
# Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff part 2

# 5. Reporting Recommendations : 권장사항 보고

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2 changes: 1 addition & 1 deletion _sources/docs/E9R1_part1.md
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# E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS
# E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS part 1

# 1. PURPOSE AND SCOPE (A.1)

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2 changes: 1 addition & 1 deletion _sources/docs/E9R1_part2.md
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# E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS
# E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS part 2

# 4. IMPACT ON TRIAL DESIGN AND CONDUCT

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5 changes: 2 additions & 3 deletions _sources/docs/E9_part1.md
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---
title: "Guideline for Industry E9 Statistical Principles for Clinical Trials"
---
## Guideline for Industry E9 Statistical Principles for Clinical Trials part 1


# 1. INTRODUCTION

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## Guideline for Industry E9 Statistical Principles for Clinical Trials part 2

# 5. Data Analysis Considerations

Statistical Analysis Plan (SAP, 통계분석계획서)는 프로토콜이 완성되고나서 작성되어야 한다. 그리고 blind review가 끝나고 다시 검토되어야 한다.
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6 changes: 1 addition & 5 deletions _sources/docs/GCP_part1.md
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---
title: "GCP E6_R2 Part1"
---

## Good Clinical Practice (GCP)
## Good Clinical Practice (GCP) part 1

GCP의 목적은 두 가지이다. 첫째는 시험자를 보호하는 것 (human subject protection)이고, 신뢰할 수 있는 임상시험 결과(reliability of trial results)를 만드는 것이다 (2.13.).

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4 changes: 1 addition & 3 deletions _sources/docs/GCP_part2.md
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---
title: "GCP E6_R2 Part2"
---
## Good Clinical Practice (GCP) part 2

목차

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51 changes: 20 additions & 31 deletions docs/Delta_part1.html
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<meta charset="utf-8" />
<meta name="viewport" content="width=device-width, initial-scale=1.0" /><meta name="generator" content="Docutils 0.18.1: http://docutils.sourceforge.net/" />

<title> &#8212; PseudoLab [Let-Biostat-Guidance-Guide-Us]</title>
<title>DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial part 1 &#8212; PseudoLab [Let-Biostat-Guidance-Guide-Us]</title>



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</li>
</ul>
<ul class="current nav bd-sidenav">
<li class="toctree-l1"><a class="reference internal" href="GCP_part1.html">Good Clinical Practice (GCP)</a></li>
<li class="toctree-l1"><a class="reference internal" href="GCP_part1.html">Good Clinical Practice (GCP) part 1</a></li>



<li class="toctree-l1"><a class="reference internal" href="GCP_part2.html">6. Clinical trial protocol and protocol amendment(s)</a></li>
<li class="toctree-l1"><a class="reference internal" href="GCP_part2.html">Good Clinical Practice (GCP) part 2</a></li>



<li class="toctree-l1"><a class="reference internal" href="E9_part1.html">1. INTRODUCTION</a></li>

<li class="toctree-l1"><a class="reference internal" href="E9_part1.html">Guideline for Industry E9 Statistical Principles for Clinical Trials part 1</a></li>


<li class="toctree-l1"><a class="reference internal" href="E9_part2.html">5. Data Analysis Considerations</a></li>


<li class="toctree-l1"><a class="reference internal" href="Switching.html">Points to Consider on Switching between Superiority and Non-inferiority</a></li>
<li class="toctree-l1"><a class="reference internal" href="E9_part2.html">Guideline for Industry E9 Statistical Principles for Clinical Trials part 2</a></li>



<li class="toctree-l1"><a class="reference internal" href="Switching.html">Points to Consider on Switching between Superiority and Non-inferiority</a></li>






<li class="toctree-l1 current active"><a class="current reference internal" href="#"></a></li>

<li class="toctree-l1 current active"><a class="current reference internal" href="#">DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial part 1</a></li>
<li class="toctree-l1"><a class="reference internal" href="Delta_part2.html">DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial part2</a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part1.html"></a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part2.html"><strong><strong>Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff</strong></strong></a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part1.html">Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff part 1</a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part2.html">Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff part 2</a></li>



<li class="toctree-l1"><a class="reference internal" href="E9R1_part1.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS</a></li>
<li class="toctree-l1"><a class="reference internal" href="E9R1_part1.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS part 1</a></li>



<li class="toctree-l1"><a class="reference internal" href="E9R1_part2.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS</a></li>
<li class="toctree-l1"><a class="reference internal" href="E9R1_part2.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS part 2</a></li>



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<h1></h1>
<h1>DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial part 1</h1>
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<ul class="visible nav section-nav flex-column">
<li class="toc-h1 nav-item toc-entry"><a class="reference internal nav-link" href="#"></a></li>
<li class="toc-h1 nav-item toc-entry"><a class="reference internal nav-link" href="#delta2-guidance-on-choosing-the-target-difference-and-undertaking-and-reporting-the-sample-size-calculation-for-a-randomized-controlled-trial"><strong>DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial 리뷰</strong></a><ul class="visible nav section-nav flex-column">
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#information"><strong>Information</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#id2"><strong>논문 소개</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#id1"><strong>논문 소개</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#the-delta2-project"><strong>The DELTA2 project</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#box-1-delta2-recommendations-for-researchers-undertaking-a-sample-size-calculation-and-choosing-the-target-difference"><strong>Box 1: DELTA2 recommendations for researchers undertaking a sample size calculation and choosing the target difference</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#the-target-difference-and-sample-size-calculations-in-randomised-controlled-trials"><strong>The target difference and sample size calculations in randomised controlled trials</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#rct"><strong>RCT 연구에서의 목표 차이값과 표본수 산출</strong></a></li>
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<h1><a class="headerlink" href="#id1" title="Permalink to this heading">#</a></h1>
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<section class="tex2jax_ignore mathjax_ignore" id="delta2-guidance-on-choosing-the-target-difference-and-undertaking-and-reporting-the-sample-size-calculation-for-a-randomized-controlled-trial">
<h1><strong>DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial 리뷰</strong><a class="headerlink" href="#delta2-guidance-on-choosing-the-target-difference-and-undertaking-and-reporting-the-sample-size-calculation-for-a-randomized-controlled-trial" title="Permalink to this heading">#</a></h1>
<section class="tex2jax_ignore mathjax_ignore" id="delta2-guidance-on-choosing-the-target-difference-and-undertaking-and-reporting-the-sample-size-calculation-for-a-randomized-controlled-trial-part-1">
<h1>DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial part 1<a class="headerlink" href="#delta2-guidance-on-choosing-the-target-difference-and-undertaking-and-reporting-the-sample-size-calculation-for-a-randomized-controlled-trial-part-1" title="Permalink to this heading">#</a></h1>
<p><a class="reference external" href="https://lh4.googleusercontent.com/pno7K44oyUgCTg8M6IuAgTSCyqV_GWwY1Cx8Oky6SMjnzEgzQlLYdtP3wmXBmjnLOttizR_SfRkzN6T6mUumMsJDvsBlhFmfW8o0mZnuFJ8qiCD_57m-8NDlrzAEeStdHL64lusoLoBWIP7t1jdtHbk">https://lh4.googleusercontent.com/pno7K44oyUgCTg8M6IuAgTSCyqV_GWwY1Cx8Oky6SMjnzEgzQlLYdtP3wmXBmjnLOttizR_SfRkzN6T6mUumMsJDvsBlhFmfW8o0mZnuFJ8qiCD_57m-8NDlrzAEeStdHL64lusoLoBWIP7t1jdtHbk</a></p>
<p><strong>2023년 07월 31일</strong></p>
<section id="information">
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</li>
</ul>
</section>
<section id="id2">
<h2><strong>논문 소개</strong><a class="headerlink" href="#id2" title="Permalink to this heading">#</a></h2>
<section id="id1">
<h2><strong>논문 소개</strong><a class="headerlink" href="#id1" title="Permalink to this heading">#</a></h2>
<p>DELTA2 Guidance는 RCT(Randomised Clinical Trial) 임상 연구에서 목표하는 차이값(target difference)과 이에 따라 계산되는 표본 수 산출(sample size calculation)에 대한 Guidance로 University of Oxford의 Centre for Statistics in Medicine 에서 2019년에 최종 버전이 발표되었습니다.</p>
<p>이 논문에서는 이 Guidance의 주요 내용(target difference 설정 및 표본수 산출)에 대해 설명하고 있습니다.</p>
</section>
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</div>
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<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#information"><strong>Information</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#id2"><strong>논문 소개</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#id1"><strong>논문 소개</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#the-delta2-project"><strong>The DELTA2 project</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#box-1-delta2-recommendations-for-researchers-undertaking-a-sample-size-calculation-and-choosing-the-target-difference"><strong>Box 1: DELTA2 recommendations for researchers undertaking a sample size calculation and choosing the target difference</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#the-target-difference-and-sample-size-calculations-in-randomised-controlled-trials"><strong>The target difference and sample size calculations in randomised controlled trials</strong></a></li>
<li class="toc-h2 nav-item toc-entry"><a class="reference internal nav-link" href="#rct"><strong>RCT 연구에서의 목표 차이값과 표본수 산출</strong></a></li>
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<li class="toctree-l1"><a class="reference internal" href="GCP_part1.html">Good Clinical Practice (GCP) part 1</a></li>



<li class="toctree-l1"><a class="reference internal" href="GCP_part2.html">6. Clinical trial protocol and protocol amendment(s)</a></li>
<li class="toctree-l1"><a class="reference internal" href="GCP_part2.html">Good Clinical Practice (GCP) part 2</a></li>



<li class="toctree-l1"><a class="reference internal" href="E9_part1.html">1. INTRODUCTION</a></li>

<li class="toctree-l1"><a class="reference internal" href="E9_part1.html">Guideline for Industry E9 Statistical Principles for Clinical Trials part 1</a></li>


<li class="toctree-l1"><a class="reference internal" href="E9_part2.html">5. Data Analysis Considerations</a></li>


<li class="toctree-l1"><a class="reference internal" href="Switching.html">Points to Consider on Switching between Superiority and Non-inferiority</a></li>
<li class="toctree-l1"><a class="reference internal" href="E9_part2.html">Guideline for Industry E9 Statistical Principles for Clinical Trials part 2</a></li>



<li class="toctree-l1"><a class="reference internal" href="Switching.html">Points to Consider on Switching between Superiority and Non-inferiority</a></li>






<li class="toctree-l1"><a class="reference internal" href="Delta_part1.html"></a></li>

<li class="toctree-l1"><a class="reference internal" href="Delta_part1.html">DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial part 1</a></li>
<li class="toctree-l1 current active"><a class="current reference internal" href="#">DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial part2</a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part1.html"></a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part2.html"><strong><strong>Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff</strong></strong></a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part1.html">Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff part 1</a></li>
<li class="toctree-l1"><a class="reference internal" href="Diagnostic_part2.html">Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff part 2</a></li>



<li class="toctree-l1"><a class="reference internal" href="E9R1_part1.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS</a></li>
<li class="toctree-l1"><a class="reference internal" href="E9R1_part1.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS part 1</a></li>



<li class="toctree-l1"><a class="reference internal" href="E9R1_part2.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS</a></li>
<li class="toctree-l1"><a class="reference internal" href="E9R1_part2.html">E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS part 2</a></li>



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