Introduction
1 臨床研究概述：全貌顯現 1
An overview of clinical research: the lay of the land Observational studies
2 描述型研究：能做與不能做的 15
Descriptive studies: what they can and cannot do
3 觀察性研究的偏差及因果相關性 29
Bias and causal associations in observational research
4 世代研究：朝結果邁進 43
Cohort studies: marching towards outcomes
5 病例對照研究：反向研究 55
Case-control studies: research in reverse
6 與什麼比較為病例對照研究尋找對照組 67
Compared to what? finding controls for case-control studies Screening tests
7 篩檢的使用與濫用 79
Uses and abuses of screening tests
8 用相似比來精進臨床診斷 91
Refining clinical diagnosis with likelihood ratios
Randomised controlled trials
9 隨機試驗的樣本數計算：強制且神秘 107
Sample size calculations in randomised trials: mandatory and mystical
10 隨機試驗之分派序列的產生：機運，而非選擇 121
Generation of allocation sequences in randomised trials: chance, not choice
11 隨機試驗的隱匿分配：防止破解 135
Allocation concealment in randomised trials: defending against deciphering
12 隨機試驗組別間不均等的樣本數：以監控對抗猜測 149
Unequal group sizes in randomised trials: guarding against guessing
13 隨機試驗期間的樣本數滑落：排除、流失、與反覆無常 163
Sample size slippages in randomised trials: exclusions and the lost and wayward
14 隨機試驗中的盲性作業：隱匿誰取得甚麼 175
Blinding in randomised trials: hiding who got what
15 隨機試驗的多重性 I：試驗指標與處理 189
Multiplicity in randomised trials I: endpoints and treatments
16 隨機試驗的多重性 II：子群及期間分析 201
Multiplicity in randomised trials II: subgroup and interim analyses
本書作者Dr. Kenneth F. Schulz和Dr. David A. Grimes乃極富經驗之臨床研究及流行病學專家，將他們受Lancet主編所邀發表於Lancet有關臨床研究方法學的系列文章集結成冊。每一篇文章皆經過同儕審查及廣大Lancet讀者群的審閱，自成專論，意義自屬非凡。Elsevier台灣分公司將本書作成中譯本，並經財團法人醫藥品查驗中心資深同仁崇安醫師、詹明曉醫師及宮玫芬統計博士詳細譯校，務求其中名詞、概念皆正確傳達原文，相信此中譯本的完成，將對國內從事臨床研究的產、官、學、研各界帶來莫大助益，就是對一般臨床醫師的閱讀臨床研究文獻及參採其結果，提供一正確的批判式思維。
