Details

A Manager's Guide to the Design and Conduct of Clinical Trials

2. Aufl.

von: Phillip I. Good
112,99 €
Verlag:	Wiley
Format:	PDF
Veröffentl.:	28.04.2006
ISBN/EAN:	9780471930877
Sprache:	englisch
Anzahl Seiten:	272

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Beschreibungen

Titelbeschreibung

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 incorporateshumorous 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"-includethe 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, and students in public health will find A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ." -Statistics in Medicine "The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." -Technometrics "This book is must-have reading for anyone in the business . . ." -Clinical Chemistry

Inhaltsverzeichnis

1 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 2 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 Part I Plan 15 3 Prescription for Success 17 Plan 17 A. Predesign Phase 17 B. Design the Trials 17 Do 19 C. Obtain Regulatory Agency Approval for the Trials 19 D. Form the Implementation Team 19 E. Line Up Your Panel of Physicians 19 F. Develop the Data Entry Software 19 G. Test the Software 20 H. Train 20 I. Recruit Patients 20 J. Set Up External Review Committees 20 K. Conduct the Trials 20 L. Develop Suite of Programs for Use in Data Analysis 20 M. Analyze and Interpret the Data 21 Check 21 N. Complete the Submission 21 4 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 5 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 6 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 7 Exception Handling 75 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 Part II Do 81 8 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 9 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 10 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 11 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 12 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 13 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 14 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 15 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 Part III Check 225 16 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 Appendix 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

Rezension

"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)

Autorenportrait

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.

Back cover copy

A MANAGER'S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS Second Edition PHILLIP I. GOOD, PH.D. 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 fi nally performing essential checks, the book's three sections—"Plan," "Do," and "Check"—include the following material: <ul> <li>Should the trials be conducted?</li> <li>Put it in the computer and keep it there</li> <li>Staffi ng for success</li> <li>Designing trials and determining sample size</li> <li>Budgeting</li> <li>Recruiting and retaining patients and physicians</li> <li>Data management</li> <li>Monitoring the trials</li> <li>Data analysis</li> <li>After action review</li> <li>Exception handling</li> </ul> Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ." —Statistics in Medicine "The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." —Technometrics "This book is must-have reading for anyone in the business . . ."—Clinical Chemistry