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. |
From inside the book
Results 1-5 of 83
Page xii
... of protection for multiple looks for safety monitoring 9.3.14 Degree of type I and II error protection for multiple clinical trials outcomes 9.4 Sample size formulas 9.4.1 Binary outcome measures 9.4.1.1 Fisher's xii Contents.
... of protection for multiple looks for safety monitoring 9.3.14 Degree of type I and II error protection for multiple clinical trials outcomes 9.4 Sample size formulas 9.4.1 Binary outcome measures 9.4.1.1 Fisher's xii Contents.
Page xv
... 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 control procedures ...
... 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 control procedures ...
Page xvi
... monitoring 21.7 Negotiations and award 21.8 Grant and contract 20.1 Introduction administration 20.2 Procedural issues 21.9 Special funding issues 20.3 Treatment monitoring reports 21.9.1 Direct versus indirect 20.4 Special statistical ...
... monitoring 21.7 Negotiations and award 21.8 Grant and contract 20.1 Introduction administration 20.2 Procedural issues 21.9 Special funding issues 20.3 Treatment monitoring reports 21.9.1 Direct versus indirect 20.4 Special statistical ...
Page xvii
... monitoring : An essential function PART VI . REPORTING 22.4 Advisory - review functions PROCEDURES 22.5 Committee procedures 22.6 Preferred separation of Chapter 24. Study publication and responsibilities and functions information ...
... monitoring : An essential function PART VI . REPORTING 22.4 Advisory - review functions PROCEDURES 22.5 Committee procedures 22.6 Preferred separation of Chapter 24. Study publication and responsibilities and functions information ...
Page xviii
... monitoring report Appendix D. Activities by stage of trial G.1 Introduction Appendix E. Sample consent statements G ... Monitoring Report ( January 31 , 1982 Report ) Appendix F. Data items and forms illustrations G.5 Listing of tables ...
... monitoring report Appendix D. Activities by stage of trial G.1 Introduction Appendix E. Sample consent statements G ... Monitoring Report ( January 31 , 1982 Report ) Appendix F. Data items and forms illustrations G.5 Listing of tables ...
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