A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials

Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the worlds leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethicsproviding a treasure trove of key terms and ideas.

This new edition continues to supply readers with the AZ terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study.

The most up-to-date work of its kind,Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.

CURTIS L. MEINERT, PhD,is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical Trials. Dr. Meinert has focused his research on the methodological issues in clinical trials, including their design, conduct, policy, and practice. He is the author ofClinical Trials Handbook: Design and Conduct (Wiley).

FOREWORD 1ST EDITION ix

PREFACE xi

CONTRIBUTORS xiii

EXPLANATORY NOTES xv

Domain of coverage xv
Order and place of entries xv
Synonyms, antonyms, and related terms xv
Language and usage conventions xv
Sources and references xvi
Adages xvi
Usage notes xvi
Etymologies xvi
Abbreviations xvii
Index xvii

USAGE PRACTICES, CAUTIONS, AND RECOMMENDATIONS xix

Recommended and preferred usages xx
Comparative and relative terms xxii
Redundancies, repetitions, and unnecessary words xxiii
Not saying what we mean xxv
Humanizing the inanimate xxv
Pre-, post-, non-, and un- words xxvi
Small troublesome words xxvi
The language of praise, implied value judgment, and presumption xxvii
Euphemisms xxix
Currency words xxix
The language of criticism xxx
The language of exception xxxi
The language of intimidation, implication, and position xxxii
The language of division xxxiii
Usurpative language xxxiii
The language of positivity and negativity xxxiv
Pronouns xxxvii
The language of equivocation and weaseling xxxvii
Vacuous language and claims xxxviii
Jargon xxxviii
Truth by declaration and repetition xxxix

ABBREVIATIONS xli

LISTING OF ENTRIES xlvii
Dictionary
A 1
B 15
C 27
D 63
E 79
F 93
G 107
H 113
I 119
J and K 137
L 141
M 151
N 165
O 175
P 185
Q 217
R 221
S 241
T 273
U 291
V 297
W 301
X, Y, and Z 305

REFERENCES 307

INDEX 317

EQUATIONS AND FUNCTIONS

Bayes' theorem 18
Binomial distribution 22
Binomial theorem 22
Bivariate normal distribution 23
Exponential distribution 90
F-test statistic 93
Gamma distribution 107
Gamma function 107
Geometric distribution 108
Gompertz's curve 108
Greco-Latin square 110
Hypergeometric distribution 117
Inverse sine transformation 133
Kappa statistic 138
Kendalls tau 139
Latin square 141
Normal distribution 172
Poisson distribution 199
Square root transformation 256
t distribution 273

GRAPHIC ILLUSTRATIONS

Figure 1. Bar Diagram 16
Figure 2. Bell-Shaped Curve 18
Figure 3. Bimodal Distribution 21
Figure 4. Box Plot 25
Figure 5. Chi-square Distribution 31
Figure 6. Circle Graph 32
Figure 7. Closed Sequential Design 37
Figure 8. CONSORT Chart 52
Figure 9. Cumulative Frequency Distribution 60
Figure 10. Exponential Distribution 90
Figure 11. F Distribution 93
Figure 12. Flowchart 99
Figure 13. Forest Plot 101
Figure 14. Frequency Polygon 103
Figure 15. Gantt Chart 107
Figure 16. Histogram 116
Figure 17. Isometric Graph 136
Figure 18. J-shaped Curve 137
Figure 19. Left Skew Distribution 143
Figure 20. Logistic Curve 147
Figure 21. Normal Distribution 172
Figure 22. Open Sequential Design 180
Figure 23. Poisson Distribution 199
Figure 24. Right Skew Distribution 239
Figure 25. s-shaped Curve 241
Figure 26. Scatter Diagram 243
Figure 27. Survival Curve 270
Figure 28. t Distribution 273
Figure 29. Uniform Distribution 294
Figure 30. Venn Diagram 299