Strategic Scientific and Medical Writing : The Road to Success

A Document May Be Based On Accurate Medical And Scientific Information, Follow Guidelines Precisely, And Be Well Written In Clear And Correct Language, But May Still Fail To Achieve Its Objectives. The Strategic Approach Described In This Book Will Help You To Turn Good Medical And Scientific Writing Into Successful Writing. It Describes Clearly And Concisely How To Identify The Target Audience And The Desired Outcome, And How To Construct Key Messages For A Wide Spectrum Of Documents. Irrespective Of Your Level Of Expertise And Your Seniority In The Pharmaceutical, Regulatory, Or Academic Environment, This Book Is An Essential Addition To Your Supporting Library. The Authors Share With You Many Years Of Combined Experience In The Pharmaceutical And Academic Environment And In The Writing Of Successful Outcome-driven Documents. Introduction -- Written Communication In Drug Development -- Written Communication In Academic Settings -- Language Pitfalls: Native English Speakers -- Language Pitfalls: Non-native English Speakers -- Scientific Misconduct -- Key Statistical Concepts -- Tables And Graphs -- International Conference On Harmonization (ich) And Other Guidelines -- The Investigators' Brochure -- Initiating Clinical Programs (ind And Impd) -- The Ctd: Overviews And Summary Documents -- Study Protocols And Reports -- Scientific Papers -- Publication Strategy. Pieter H. Joubert, Silvia M. Rogers. Includes Bibliographical References. Mode Of Access: World Wide Web. Preface 6 Contents 8 List of Tables 14 List of Figures 16 About the Authors 18 Chapter 1: Introduction 20 1.1 Why Bother with Writing Skills? 20 1.2 The Key Components of Good Medical/Scientific Writing 21 1.2.1 Strategy 22 1.2.2 Science 22 1.2.3 Guidelines 22 1.2.4 Language 23 1.2.5 Tools 23 1.3 How to Plan a Document 23 1.3.1 The Nature of the Document 24 1.3.2 The Desired Outcome 24 1.3.3 Guidelines 24 1.3.4 Target Audience 25 1.3.5 Key Messages 25 1.3.6 Sources of Information 25 1.4 Using a Template 25 1.5 Final Thoughts 26 Chapter 2: Written Communication in Drug Development 27 2.1 Where Is Written Communication Used in Drug Development? 27 2.1.1 Recording Nonclinical Findings 28 2.1.2 Preparing Drug Development Documents 28 2.1.3 Communicating with Regulatory Authorities and Other Important Institutions 28 2.2 Final Thoughts 30 Chapter 3: Written Communication in Academic Settings 31 3.1 Where Is Communication Used in the Academic Setting? 31 3.2 Scientific Papers 31 3.3 Theses and Dissertations 32 3.3.1 Master’s Thesis/Dissertation 32 3.3.2 Doctoral Dissertation/Thesis 33 3.4 Other Student Papers 35 3.4.1 Laboratory Reports 35 3.4.2 Research Proposals 36 3.5 Application for Ethics Approval 38 3.6 Grant Applications 39 3.7 Final Thoughts 41 Chapter 4: Language Pitfalls: Native English Speakers 42 4.1 Do Native English Speakers Have an Advantage? 42 4.2 Misused Terms and Expressions 42 4.3 Problems with Singular and Plural Nouns 44 4.3.1 Plurals of Non-English Nouns 44 4.3.2 Collective Nouns 46 4.4 Punctuation 46 4.4.1 Comma 47 4.4.2 Hyphen 47 4.4.3 Other Troublesome Punctuation Marks 48 4.4.3.1 Apostrophe 48 4.4.3.2 Nonbreaking Spaces and Hyphens 49 4.5 Jargonized Writing 50 4.5.1 Carelessness and Sloppiness 50 4.5.2 Terminology 51 4.5.3 Nonparallel Clauses 51 4.6 Sentence Structure and Word Order (Syntax) 53 4.6.1 Dangling Modifiers 53 4.6.2 Misplaced Modifiers 54 4.7 Final Thoughts 54 Chapter 5: Language Pitfalls: Nonnative English Speakers 55 5.1 Do Nonnative English Speakers Have a Disadvantage? 55 5.2 Main Troublemakers for Nonnative English Speakers 55 5.2.1 Choice of Correct Tense 57 5.2.2 Avoiding Wordiness 59 5.2.3 Active Versus Passive Writing 60 5.2.4 Nonessential and Essential Clauses 61 5.2.5 Use of “Respectively” 62 5.3 Lost in Translation 63 Chapter 6: Scientific Misconduct 64 6.1 Why Does Everyone Suddenly Talk about Fraud and Plagiarism? 64 6.2 Causes of Scientific Misconduct 65 6.3 Forms of Scientific Misconduct 66 6.3.1 Data Fabrication 66 6.3.2 Data Falsification 67 6.3.3 Plagiarism 67 6.3.3.1 Self-Plagiarism 68 6.4 Other Forms of Scientific Misconduct 68 6.4.1 Provision of Incorrect or Incomplete Information 68 6.4.2 Omission of Publication 69 6.4.3 List of Authors 69 6.5 Post-publication Misconduct 70 6.5.1 Storage and Retrieval of Data 70 6.5.2 Correction and Retraction of Publications and Expression of Concern 70 6.5.2.1 Correction of a Published Article 71 6.5.2.2 Retraction of a Published Article 71 6.5.2.3 Expression of Concern 72 6.6 Final Thoughts 72 Chapter 7: Key Statistical Concepts 73 7.1 Descriptive Statistics 73 7.2 Inferential Statistics 76 7.2.1 Parametric Tests for Two Datasets 78 7.2.1.1 Student’s Two-Sample t-Test 78 7.2.1.2 Student’s Paired t-Test 79 7.2.2 Nonparametric Tests for Small Datasets 80 7.2.2.1 Mann–Whitney U Test 81 7.2.2.2 Wilcoxon Signed-Rank Test 81 7.2.3 Comparing Categories: Chi-Squared Test 82 7.2.4 Tests for Multiple Samples 84 7.3 Final Thoughts 84 Chapter 8: Tables and Graphs 85 8.1 Producing Sensible Tables 85 8.2 Sensible Use of Graphs 86 8.2.1 Illustrating the Characteristics of a Database 87 8.2.2 Comparing Databases 88 8.2.3 Showing Relationships Between Parameters 89 8.2.4 Showing Trends over Time Using Arithmetic Line Graphs 91 8.2.5 Column Charts 94 8.2.6 Inappropriate and Misleading Use of Graphs 94 8.3 Final Thoughts 97 Chapter 9: International Conference on Harmonization (ICH) and Other Guidelines 98 9.1 Achievements by the International Conference on Harmonization (ICH) 98 9.2 Quality Guidelines 99 9.3 Safety Guidelines 100 9.4 Efficacy Guidelines 100 9.5 Multidisciplinary Guidelines 100 9.6 Consistency 101 9.7 Final Thoughts 102 Chapter 10: The Investigator’s Brochure 103 10.1 Key Considerations 103 10.2 Guidelines 104 10.3 Emphasis 105 10.4 Key Messages and Outcome 106 10.5 Final Thoughts 107 Chapter 11: Initiating Clinical Programs (IND and IMPD) 108 11.1 Background 108 11.2 CTA Europe 109 11.3 Final Thoughts 112 Chapter 12: The Common Technical Document: Overviews and Summary Documents 113 12.1 The Key Components of the CTD 113 12.1.1 The First Component (Module 1) 114 12.1.2 The Second Component (Module 2) 114 12.1.3 The Third Component (Modules 3, 4, and 5) 115 12.2 Summaries That Are More Than Summaries 115 12.3 The Summaries (Module 2) 116 12.3.1 Clinical and Nonclinical Overviews (Modules 2.4 and 2.5) 116 12.3.1.1 The Nonclinical Overview (Module 2.4) 117 12.3.1.2 The Clinical Overview (Module 2.5) 117 12.4 Where Do I Start? 120 12.5 Selecting the Expert 120 12.6 Common Mistakes 120 12.7 Final Thoughts 121 Chapter 13: Study Protocols and Reports 122 13.1 Study Protocols 123 13.1.1 Where Do I Start? 124 13.1.2 Key Elements of a Protocol 124 13.1.2.1 Rationale 125 13.1.2.2 Objective(s) 125 13.1.2.3 Population(s) 126 13.1.2.4 Entry Criteria 127 13.1.2.5 Study Design 127 13.1.2.6 The Case Report Form 128 13.1.2.7 Database and Data Analysis 129 13.1.2.8 Ethics and Informed Consent 129 13.1.3 Final Thoughts 129 13.2 Study Reports 129 13.2.1 Structure and Content 129 13.2.1.1 The Core Report (FDA and EU) 130 13.2.1.2 Study Documentation (FDA and EU) 130 13.2.1.3 Efficacy Listings (FDA) 131 13.2.1.4 Safety Listings (FDA) 131 13.2.1.5 Statistical Details (FDA) 131 13.2.2 Abbreviated Study Reports 131 13.3 Planning, Teamwork, and Prototyping 132 13.4 Final Thoughts 132 Chapter 14: Scientific Papers 133 14.1 Publication Ethics 134 14.2 Why Publish? 134 14.3 Selecting the Journal 135 14.4 How Do I Plan and Write a Scientific Paper? 135 14.5 Where Do I Start? 136 14.5.1 Title and Authors 136 14.5.2 Keywords 137 14.5.3 Abstract 137 14.5.4 Introduction 137 14.5.5 Materials and Methods 137 14.5.6 Results 138 14.5.7 Discussion and Conclusions 138 14.5.8 Acknowledgments 138 14.5.9 Disclosures 138 14.5.10 References 139 14.6 Final Thoughts 139 Chapter 15: Publication Strategy 140 15.1 Publication Strategy in a Commercial Drug Development Environment 140 15.1.1 Data That Benefit the Program and Must Be Published 141 15.1.1.1 Timing of Publications 141 15.1.1.2 Author(s) of the Paper 141 15.1.1.3 Type of Paper and Choice of Journals 141 15.1.2 Publications of No Specific Benefit to the Program 142 15.2 Publication in an Academic Setting 142 15.3 Final Thoughts 143 Appendix 144 Glossary of Abbreviations Used in This Book 144 References 146 Books 146 Published Literature 146 Front Matter....Pages i-xviii Introduction....Pages 1-7 Written Communication in Drug Development....Pages 9-12 Written Communication in Academic Settings....Pages 13-23 Language Pitfalls: Native English Speakers....Pages 25-37 Language Pitfalls: Nonnative English Speakers....Pages 39-47 Scientific Misconduct....Pages 49-57 Key Statistical Concepts....Pages 59-70 Tables and Graphs....Pages 71-83 International Conference on Harmonization (ICH) and Other Guidelines....Pages 85-89 The Investigator’s Brochure....Pages 91-95 Initiating Clinical Programs (IND and IMPD)....Pages 97-101 The Common Technical Document: Overviews and Summary Documents....Pages 103-111 Study Protocols and Reports....Pages 113-123 Scientific Papers....Pages 125-131 Publication Strategy....Pages 133-136 Back Matter....Pages 137-140