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