Clinical Trials: Design, Conduct, and AnalysisOxford University Press, 1986 - 469 pages The 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 sample size calculation, stratification and randomization, data systems design, consent form development, publication policies, preparation of funding requests, and reporting procedures. |
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Page vii
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Page ix
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Page xii
... procedures 8.3 Principles in the selection of the 6.4.1 General cost control outcome measure procedures 8.4 Principles in establishing 6.4.2 Method of funding comparable study groups 6.4.3 Cost reviews 6.4.4 Periodic priority ...
... procedures 8.3 Principles in the selection of the 6.4.1 General cost control outcome measure procedures 8.4 Principles in establishing 6.4.2 Method of funding comparable study groups 6.4.3 Cost reviews 6.4.4 Periodic priority ...
Page xv
... procedures 16.5 Monitoring for secular trends 16.6 Data integrity and assurance 13.5 Developing and testing the data procedures management system 16.7 Performance monitoring reports 13.6 Training and certification 16.8 Other quality ...
... procedures 16.5 Monitoring for secular trends 16.6 Data integrity and assurance 13.5 Developing and testing the data procedures management system 16.7 Performance monitoring reports 13.6 Training and certification 16.8 Other quality ...
Page xvii
... PROCEDURES 22.5 Committee procedures 22.6 Preferred separation of Chapter 24. Study publication and responsibilities and functions information policies 22.6.1 Separation of treatment administration and data 24.1 Information constraints ...
... PROCEDURES 22.5 Committee procedures 22.6 Preferred separation of Chapter 24. Study publication and responsibilities and functions information policies 22.6.1 Separation of treatment administration and data 24.1 Information constraints ...
Contents
A stateof | 1 |
223 | 12 |
The activities of | 18 |
Cost and related issues | 40 |
masked allocation | 90 |
Use of items from other | 119 |
Patient recruitment | 149 |
Patient followup | 185 |
randomization | 219 |
Essential management | 232 |
Preparation of | 264 |
Appendix H Budget summary | 279 |
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Common terms and phrases
Abstract summaries advisory-review allocation ratio Aspirin assess baseline Chapter clinical trial close-out consent control treatment Coronary Drug Project cost data center data collection data coordinating center data dredging data entry data forms database disease Drug Project Research Fisher's exact test follow-up visit funding Gallstone Group Diabetes Program Hypertension Institute investigators laboratory masked ment methods monitoring committee multicenter trials myocardial infarction NCGS needed niacin number of patients outcome measure p-value paper patient recruitment patients enrolled phenformin physician placebo procedures Program Research Group Project Research Group protocol publication Question randomization records responsible safety monitoring sample sample size schedule Section specified sponsor study treatments subgroups TEMC test treatment tients tion tolbutamide treat treatment allocation treatment assignment treatment effects monitoring treatment group treatment monitoring trial involving trials sketched UGDP University Group Diabetes variable Yes Yes Yes