Strategic Scientific and Medical Writing (eBook)

Pieter Joubert is a clinician specialized in Internal Medicine in South Africa and trained in Clinical Pharmacology at the University of Rochester, USA. During a successful academic clinical pharmacology career, he was a member of several boards and committees. He also reviewed applications for approval of new drugs for the South African Health Authority. His key areas of clinical experience are in cardiovascular disease, nephrology, and diabetes. He has extensive drug development experience in the pharmaceutical industry, the major part as Global Head of Clinical Pharmacology at F. Hofmann-La Roche, Switzerland. He currently holds an honorary professorship of Pharmacology and Therapeutics at the Medical University of Southern Africa, and a visiting professorship in Pharmaceutical Medicine at the University of Surrey, UK. He has acted as a consultant to numerous pharmaceutical and biotechnology companies and has published extensively in books and scientific journals.Silvia M. Rogers is the founder and owner of MEDIWRITE GmbH, a successful small company in Basel, Switzerland. She trained at the University of Liverpool, UK, in the Department of Pharmacology and Therapeutics headed by Prof. Sir Alasdair Breckenridge (former Head of the MRCA). Before forming MEDIWRITE in 1994, she gained extensive experience in key areas of pharmaceutical research, including project management in a major pharmaceutical company. She is an active member of the American Medical Writers Association (AMWA) and the European Medical Writers Association (EMWA). She lectures on scientific writing at Basel University and has provided extensive training in various aspects of medical and scientific writing and presentation. She has written many expert reports, regulatory documents, study reports, and scientific publications for clients, and has authored the popular book 'Mastering Scientific and Medical Writing' (2nd ed., Springer, 2014).

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