A Managers' Guide to the Design and Conduct of Clinical Trials / Edition 2

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This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.

Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.

This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporates humorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-include the following material: Should the trials be conducted? Put it in the computer and keep it there, Staffing for success, Designing trials and determining sample size, Budgeting, Recruiting and retaining patients and physicians, Data management, Monitoring the trials, Data analysis, After action review, Exception handling.

Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, andstudents in public health will find A Manager's Guide an indispensable resource.

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Editorial Reviews

From the Publisher
"With this book in hand, people who manage the people who manage clinical trials can intelligently supervise their staff." (Journal of Clinical Research Best Practices, November 2007)

"…a useful tool for understanding the entire clinical trial process." (Journal of Biopharmaceutical Statistics, Vol. 17, Issue 3, 2007)

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Product Details

  • ISBN-13: 9780471788706
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 4/21/2006
  • Series: Manager's Guide Series
  • Edition description: REV
  • Edition number: 2
  • Pages: 272
  • Sales rank: 1,141,125
  • Product dimensions: 6.46 (w) x 9.65 (h) x 0.79 (d)

Meet the Author

Phillip Good, Ph.D., a graduate of UC Berkeley's statistics program, is the author of sixteen published books. He has 23 years of experience in the pharmaceutical and medical device industries, first with Upjohn, and then as an independent consultant. He has taught anatomy and biology, and has also served as Calloway Professor of Computer Science at the University of Georgia at Fort Valley. Dr. Good has lectured extensively throughout the world, including an appointment as traveling lecturer for the American Statistical Association.
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Table of Contents

Cut Costs and Increase Profits     1
No Excuse for the Wastage     1
Front-Loaded Solution     2
Downsizing     3
Think Transnational     3
A Final Word     4
Guidelines     7
Start with Your Reports     7
The Wrong Way     9
Keep It in the Computer     9
Don't Push the River     10
KISS     11
Plug the Holes as They Arise     12
Pay for Results, Not Intentions     13
Plan, Do, Then Check     13
Plan     15
Prescription for Success     17
Plan     17
Predesign Phase     17
Design the Trials     17
Do     19
Obtain Regulatory Agency Approval for the Trials     19
Form the Implementation Team     19
Line Up Your Panel of Physicians     19
Develop the Data Entry Software     19
Test the Software     20
Train     20
Recruit Patients     20
Set Up External Review Committees     20
Conduct the Trials     20
Develop Suite of Programs for Use in Data Analysis     20
Analyze and Interpret the Data     21
Check     21
Complete the Submission     21
Staffing for Success     23
The People You Need     23
Design Team     23
Obtain Regulatory Approval for the Trials     25
Track Progress     25
Implementation Team     26
Develop Data Entry Software     26
Test the Software     27
Line Up Your Panel of Physicians     28
External Laboratories     28
Site Coordinators     28
External Review Committees     29
Recruit and Enroll Patients     29
Transnational Trials     30
Conduct the Trials     30
Programs for Data Analysis     30
Analyze and Interpret the Data     31
The People You Don't Need     31
For Further Information     33
Design Decisions     35
Should the Study Be Performed?     36
Should the Trials Be Transnational?     37
Study Objectives     37
End Points     38
Secondary End Points     39
Should We Proceed with a Full-Scale Trial?      41
Tertiary End Points     41
Baseline Data     41
Who Will Collect the Data?     41
Quality Control     42
Study Population     44
Timing     45
Closure     46
Planned Closure     46
Unplanned Closure     46
Be Defensive. Review, Rewrite, Review Again     49
Checklist for Design     50
Budgets and Expenditures     50
For Further Information     51
Trial Design     55
Baseline Measurements     56
Controlled Randomized Clinical Trials     57
Randomized Trials     58
Blocked Randomization     59
Stratified Randomization     60
Single- vs. Double-Blind Studies     60
Allocation Concealment     62
Exceptions to the Rule     62
Sample Size     63
Which Formula?     64
Precision of Estimates     64
Bounding Type I and Type II Errors     66
Equivalence     68
Software     68
Subsamples     69
Loss Adjustment     69
Number of Treatment Sites      70
Alternate Designs     70
Taking Cost into Consideration     72
For Further Information     73
Exception Handling     76
Patient Related     75
Missed Doses     75
Missed Appointments     75
Noncompliance     76
Adverse Reactions     76
Reporting Adverse Events     76
When Do You Crack the Code?     77
Investigator Related     77
Lagging Recruitment     77
Protocol Deviations     78
Site-Specific Problems     78
Closure     79
Intent to Treat     80
Is Your Planning Complete?     80
Do     81
Documentation     83
Guidelines     84
Common Technical Document     84
Reporting Adverse Events     86
Initial Submission to the Regulatory Agency     87
Sponsor Data     88
Justifying the Study     88
Objectives     89
Patient Selection     89
Treatment Plan     90
Outcome Measures and Evaluation     90
Procedures     90
Clinical Follow-Up      90
Adverse Events     91
Data Management, Monitoring, Quality Control     91
Statistical Analysis     91
Investigator Responsibilities     92
Ethical and Regulatory Considerations     93
Study Committees     93
Appendixes     94
Sample Informed Consent Form     94
Procedures Manuals     95
Physician's Procedures Manual     96
Laboratory Guidelines     97
Interim Reports     97
Enrollment Report     98
Data in Hand     98
Adverse Event Report     99
Annotated Abstract     99
Final Reports(s)     102
Regulatory Agency Submissions     102
e-Subs     104
Journal Articles     104
For Further Information     105
Recruiting and Retaining Patients and Physicians     107
Selecting Your Clinical Sites     107
Recruiting Physicians     108
Teaching Hospitals     109
Clinical Resource Centers     109
Look to Motivations     110
Physician Retention     111
Get the Trials in Motion      111
Patient Recruitment     112
Factors in Recruitment     112
Importance of Planning     113
Ethical Considerations     114
Mass Recruiting     114
Patient Retention     115
Ongoing Efforts     116
Run-In Period     117
Budgets and Expenditures     118
For Further Information     118
Computer-Assisted Data Entry     123
Pre-Data Screen Development Checklist     124
Develop the Data Entry Software     124
Avoid Predefined Groupings in Responses     126
Screen Development     126
Radio Button     128
Pull-Down Menus     129
Type and Verify     129
When the Entries Are Completed     130
Audit Trail     132
Electronic Data Capture     132
Data Storage: CDISC Guidelines     133
Testing     136
Formal Testing     137
Stress Testing     138
Training     139
Reminder     139
Support     140
Budgets and Expenditures     141
For Further Information     141
Data Management      143
Options     143
Flat Files     143
Hierarchical Databases     145
Network Database Model     146
Relational Database Model     146
Which Database Model?     149
Object-Oriented Databases     150
Clients and Servers     150
One Size Does Not Fit All     151
Combining Multiple Databases     151
A Recipe for Disaster     152
Transferring Data     154
Quality Assurance and Security     155
Maintaining Patient Confidentiality     155
Access to Files     155
Maintaining an Audit Trail     157
Security     157
For Further Information     158
Are You Ready?     161
Pharmaceuticals/Devices     161
Software     162
Hardware     162
Documentation     162
Investigators     162
External Laboratories     163
Review Committees     163
Patients     163
Regulatory Agency     163
Test Phase     163
Monitoring the Trials     165
Roles of the Monitors      165
Before the Trials Begin     167
Kick-Off Meetings     168
Duties During Trial     169
Site Visits     169
Between Visits     170
Other Duties     173
Maintaining Physician Interest in Lengthy Trials     173
Managing the Trials     175
Recruitment     176
Supplies     176
Late and Incomplete Forms     176
Dropouts and Withdrawals     178
Protocol Violations     178
Adverse Events     179
Quality Control     179
Visualize the Data     180
Roles of the Committees     183
Termination and Extension     184
Extending the Trials     186
Budgets and Expenditures     186
For Further Information     187
Data Analysis     189
Report Coverage     189
Understanding Data     190
Categories     190
Metric Data     192
Statistical Analysis     194
Categorical Data     196
Ordinal Data     197
Metric Data     198
An Example      199
Time-to-Event Data     200
Step By Step     203
The Study Population     203
Reporting Primary End Points     204
Exceptions     204
Adverse Events     207
Analytical Alternatives     207
When Statisticians Can't Agree     208
Testing for Equivalence     209
Simpson's Paradox     210
Estimating Precision     211
Bad Statistics     213
Using the Wrong Method     213
Deming Regression     213
Choosing the Most Favorable Statistic     214
Making Repeated Tests on the Same Data     214
Ad Hoc, Post Hoc Hypotheses     215
Interpretation     217
Documentation     218
For Further Information     219
A Practical Guide To Statistical Terminology     222
Check     225
Check     227
Closure     227
Patient Care     227
Data     228
Spreading the News     228
Postmarket Surveillance     228
Budget     228
Controlling Expenditures     229
Process Review Committee      229
Trial Review Committee     230
Investigatory Drug or Device     230
Interactions     232
Adverse Events     232
Collateral Studies     233
Future Studies     234
For Further Information     234
Software     237
Choices     237
All In One     237
Almost All In One     238
Project Management     238
Data Entry     239
Handheld Devices     239
Touch Screen     239
Speech Recognition     239
e-CRFs     240
Do It Yourself     240
Data Collection Via the Web     240
Preparing the Common Technical Document     241
Data Management     241
Data Entry and Data Management     242
Small-Scale Clinical Studies     242
Clinical Database Managers     242
Data Analysis     243
Utilities     244
Sample Size Determination     244
Screen Capture     245
Data Conversion     245
Author Index     247
Subject Index     251
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