书名：A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS
部分目录：
PART ONE PLAN 1
1 Cut Costs and Increase Profits 3
No Excuse for the Wastage 3
Front-Loaded Solution 4
Downsizing 5
A Final Word 5
2 Guidelines 9
Start with Your Reports 9
The Wrong Way 11
Computer-Assisted Data Entry 11
Don’t Push the River 12
KISS 12
Plug the Holes as They Arise 14
Pay for Results, Not Intentions 14
Plan, Do, Then Check 14
3 Prescription for Success 15
Plan 15
Do 16
Check 18
4 Staffing for Success 19
Design Team 19
Regulatory Approval 21
Implementation Team 21
5 Design Decisions 29
Should the Study Be Performed? 30
Study Objectives 30
Primary End Points 32
Secondary End Points 34
Baseline Data 35
Who Will Collect the Data 36
Quality Control 36
Study Population 37
Timing 39
Closure 40
Planned Closure 40
Unplanned Closure 41
Be Defensive. Review. Rewrite. Review Again 42
Checklist for Design 43
Budgets and Expenditures 44
For Further Information 44
6 Trial Design 47
Baseline Measurements 48
Controlled Randomized Clinical Trials 48
Randomized Trials 50
Blocked Randomization 50
Stratified Randomization 51
Single- and Double-Blind Studies 52
Exceptions to the Rule 54
Sample Size 54
Which Formula? 54
Precision of Estimates 55
Number of Treatment Sites 60
Alternate Designs 60
7 Exception Handling 65
Patient Related 65
Missed Doses 65
Missed Appointments 65
Noncompliance 66
Adverse Reactions 66
Reporting Adverse Events 66
When Do You Crack the Code? 67
Investigator Related 68
Lagging Recruitment 68
Protocol Deviations 68
Site-Specific Problems 69
Closure 70
Intent to Treat 70
Is Your Planning Complete? A Checklist 71