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<p>Preface 4</p> <p>Aims of this book 5</p> <p><b>Chapter 1 The rationale for treatment: a brief history 7</b></p> <p>Conclusion 14</p> <p>References 15</p> <p><b>Chapter 2 Sources of bias in randomised controlled trials 18</b></p> <p>Method of treatment allocation 18</p> <p>Problems in measuring the outcome 20</p> <p>Follow-up and missing outcomes 22</p> <p>Missing outcome data and intention to treat 23</p> <p>Other methodological concerns 24</p> <p>Conclusions 26</p> <p>References 27</p> <p><b>Chapter 3 Wasted and unhelpful trials 34</b></p> <p>Wasted Studies 34</p> <p>Neglected areas of research 35</p> <p>Unhelpful outcome measures 35</p> <p>Lack of generalisability 37</p> <p>Weak and misleading evidence 39</p> <p>Conclusion 40</p> <p>References 40</p> <p><b>Chapter 4 Can the analysis bias the findings? 46</b></p> <p>The p-value problem 46</p> <p>Questionable research practices 48</p> <p>Ensuring high quality analysis: the Statistical Analysis Plan 50</p> <p>Conclusions 51</p> <p>References 52</p> <p><b>Chapter 5 Systematic reviews and Meta-analysis 56</b></p> <p>Introduction 56</p> <p>Identifying relevant trials 57</p> <p>Extracting trial data 59</p> <p>The quality of primary trials 61</p> <p>Pooling effect sizes across trials 62</p> <p>Other methodological issues 63</p> <p>Conclusions 65</p> <p>References 66</p> <p><b>Chapter 6 Fabrication, falsification and spin 73</b></p> <p>Fabrication 73</p> <p>Falsification 75</p> <p>Questionable Research Practices 76</p> <p>Spin 76</p> <p>Retractions 78</p> <p>Discussion 78</p> <p>References 79</p> <p><b>Chapter 7 Why do researchers falsify data or manipulate study findings? 83</b></p> <p>The research environment 83</p> <p>Research oversight 86</p> <p>Conflict of interest 88</p> <p>Individual level explanations for research misconduct 90</p> <p>How honest people rationalise misconduct 91</p> <p>Discussion 93</p> <p>References 94</p> <p><b>Chapter 8 Developing a strategy to prevent poor quality and misleading research 103</b></p> <p>Research environment 103</p> <p>Research transparency 105</p> <p>Research oversight 106</p> <p>Research integrity 107</p> <p>Essential elements of a transformational strategy 108</p> <p>Implementing a programme for action 112</p> <p>References 113</p> <p><b>Appendix 1 Summary of the key findings on poor quality research 118</b></p> <p>Problems in the design, conduct, analysis and reporting of studies 118</p> <p>Frequency of data fabrication and falsification 120</p> <p>The causes of poor quality and misleading research 120</p> <p>The findings in perspective 121</p> <p>References 122</p> <p><b>Appendix 2 Initiatives to improve the quality of research 123</b></p> <p>Change the research environment 123</p> <p>Improve training 125</p> <p>Increase research transparency 126</p> <p>Quality of trial methodology 128</p> <p>Trial registration 130</p> <p>Reporting of the methods of systematic reviews 130</p> <p>Increasing access to and use of reporting guidelines 132</p> <p>Implement vigorous research oversight 132</p> <p>Promote research integrity 136</p> <p>Examples of coordinated initiatives 140</p> <p>References 141</p> <p>Index</p>

"<i>Evidence in Medicine: The Common Flaws, Why They Occur and How to Prevent Them</i> will open your eyes to the squishy underbelly of clinical research. Given the numerous pitfalls for the unwary — and overly ingenious — investigator, it is no surprise that “possibly 85 percent of clinical research is wasted."' <b>– Journal of Clinical Research Best Practices</b>

<p><b>Iain K Crombie</b> is Emeritus Professor of Public Health at Dundee University, UK. He has published more than 160 research papers as well as books on critical appraisal, research methods, grant applications, and clinical audits. He has extensive experience teaching both undergraduate and postgraduate courses in epidemiology, medical statistics, and research methods.</p>

<p>High-quality evidence is the foundation for effective treatment in medicine. As the vast amount of published medical evidence continues to grow, concerns about the quality of many studies are increasing. <i>Evidence in Medicine</i> is a much-needed resource that addresses the ‘medical misinformation mess’ by assessing the flaws in the research environment. This authoritative text identifies and summarises the many factors that have produced the current problems in medical research, including bias in randomised controlled trials, questionable research practices, falsified data, manipulated findings, and more.</p><p>This volume brings together the findings from meta-research studies and systematic reviews to explore the quality of clinical trials and other medical research, explaining the character and consequences of poor-quality medical evidence using clear language and a wealth of supporting references. The text suggests planning strategies to transform the research process and provides an extensive list of the actions that could be taken by researchers, regulators, and other key stakeholders to address defects in medical evidence. This timely volume:</p><ul><li>Enables readers to select reliable studies and recognise misleading research</li><li>Highlights the main types of biased and wasted studies</li><li>Discusses how incentives in the research environment influence the quality of evidence</li><li>Identifies the problems researchers need to guard against in their work</li><li>Describes the scale of poor-quality research and explores why the problems are widespread</li><li>Includes a summary of key findings on poor-quality research and a listing of proposed initiatives to improve research evidence</li><li>Contains extensive citations to references, reviews, commentaries, and landmark studies</li></ul><p><i>Evidence in Medicine</i> is required reading for all researchers who create evidence, funders and publishers of medical research, students who conduct their own research studies, and healthcare practitioners wanting to deliver high-quality, evidence-based care.</p>

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