Clinical Trials: Design, Conduct, and AnalysisThe definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail as Meinert does on such issues as samplesize calculation, stratification and randomization, data systems design, consent form development, publication policies, preparation of funding requests, and reporting procedures. |
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Contents
A stateof | 1 |
and multicenter trials | 23 |
Coordinating and other | 30 |
Cost and related issues | 40 |
trials? | 49 |
Sample size and power | 71 |
Randomization and | 90 |
The study plan | 113 |
Committee structures | 240 |
REPORTING | 253 |
24 | 255 |
25 | 264 |
Locating and reading | 271 |
APPENDIXES | 279 |
28 | 309 |
253 | 321 |
visit schedule | 119 |
68 | 131 |
105 | 133 |
EXECUTION | 139 |
Patient recruitment | 149 |
Questions concerning | 154 |
Patient followup | 159 |
DATA ANALYSIS | 177 |
Data analysis requirements | 185 |
Interim data analyses | 208 |
MANAGEMENT | 217 |
21 | 219 |
Essential management | 232 |
34 | 355 |
Activities by stage of trial | 363 |
Appendix E Sample consent statements | 374 |
40 | 415 |
42 | 428 |
| 430 | |
| 432 | |
| 438 | |
| 439 | |
| 440 | |
| 447 | |
| 453 | |
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Common terms and phrases
administration allocation ratio allocation schedule analysis Aspirin assess assigned treatment baseline block block size Chapter citation clinic personnel clinical trial close-out control treatment Coronary Drug Project data center data collection data coordinating center data dredging data entry data forms database Drug Project Research ECGs error Fisher's exact test follow-up visits funding Gallstone Glossary Group Diabetes Program Hypertension Illustration indicate investigators masked ment methods multicenter trials myocardial infarction needed number of patients outcome measure p-value paper patient recruitment patients enrolled phenformin physician placebo procedures Program Research Group Project Research Group protocol Question random numbers record responsible safety monitoring sample size sample size calculation scheme Section sketched in Appendix specified sponsor stratification study treatments Table test treatment tients tion tolbutamide treat treatment allocation treatment assignment treatment groups trials involving trials sketched UGDP University Group Diabetes variables
References to this book
Bibliographic information
| Title | Clinical Trials: Design, Conduct, and Analysis Issue 8 of Monographs in epidemiology and biostatistics, ISSN 0740-0845 |
| Authors | Curtis L. Meinert, Susan Tonascia |
| Photographs by | Susan Tonascia |
| Edition | illustrated |
| Publisher | Oxford University Press, 1986 |
| ISBN | 0195035682, 9780195035681 |
| Length | 469 pages |
| Subjects | › Medical / Epidemiology |
| Export Citation | BiBTeX EndNote RefMan |