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Clinical Research: What It Is and How It Works

by: Nesbitt, Lori A.

Clinical Research: What It Is and How It Works

by: Nesbitt, Lori A.

ISBN 13:
9780763731366
ISBN 10:
0763731366
Format: Paperback
Copyright: 07/04/2003
Publisher: Jones & Bartlett Learning

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Summary

Hardly a week goes by without a newspaper headline or an evening news report detailing a mishap or scandal in the world of clinical research. An increasingly informed public demands speedy breakthroughs in treatment while eyeing warily the risks of participation in clinical trials. The nationrs"s most prestigious medical centers suffer record fines for research misconduct And The embarrassment that goes with it. Against this backdrop those in the trenches of clinical research work under heightening pressure and scrutiny. More than ever this field demands an unprecedented level of knowledge and understanding. Clinical Research: What it is and How it Works will provide you with a fundamental yet comprehensive understanding of all phases of the clinical research process. Every aspect of clinical research from program design, regulatory issues, ethical considerations, To IRB roles and functions, quality controls, financial management, and more are explained in clear, concise language. Whether you are a seasoned researcher or a brand new member of an IRB, this book will provide a clear, thorough perspective on the clinical research process.

Preface	p. xv
Acknowledgments	p. xxi
Testing Treatments in Humans	p. 1
Testing Drugs in Humans	p. 2
	p. 3
	p. 6
	p. 7
	p. 7
Clinical Research--Not an Exact Science	p. 8
Study Design	p. 11
Control Groups	p. 14
Random Assignment	p. 18
Double-Blind	p. 19
Crossover Design	p. 21
Historical Control	p. 21
Elements of the Clinical Trial Protocol	p. 22
Background and Significance	p. 22
Specific Aims or Endpoints	p. 23
Inclusion and Exclusion Criteria	p. 24
Study Procedures	p. 25
Statistical Design	p. 25
Case Study: Evaluating the Protocol	p. 27
Data Collection During the Development of a Cancer Drug: A Hypothetical Example	p. 27
Best Practices	p. 32
Key Questions	p. 32
References	p. 33
Bioethics and Human Advocacy	p. 35
The Evolution of Ethical Principles of Clinical Research	p. 36
Respect for Persons	p. 39
Beneficence	p. 39
Justice	p. 40
How the Investigator Applies Ethical Principles	p. 40
Role of the Institutional Review Board	p. 41
Why Do Investigators Need to Know about IRBs?	p. 44
What IRB Members Should Know about Clinical Research	p. 45
What IRB Members Should Know about Their Responsibilities	p. 46
Risks Versus Benefit Analysis--The Human Advocate	p. 48
Identifying and Assessing the Risks	p. 50
Minimal Risk Versus Greater than Minimal Risk	p. 52
Vulnerable Populations and Minimal Risk	p. 53
Determining When Risks Are Minimized	p. 53
Assessing Anticipated Benefits	p. 54
Determining When Risks Are Reasonable in Relation to Anticipated Benefits	p. 55
Continuing Review and Monitoring of Data	p. 56
Informed Consent--Not Just a Document	p. 57
Elements of an Informed Consent	p. 58
Required Elements of an Informed Consent	p. 59
Additional Required Elements	p. 60
What the Site Should Know About the IRB Process	p. 61
Items Requiring IRB Approval and Oversight	p. 62
Requirements of an Investigator for Research Approval from an IRB	p. 63
Ethical Dilemmas in Clinical Research	p. 67
Best Practices	p. 71
Key Questions	p. 72
References	p. 74
The Clinical Research Industry	p. 77
Clinical Trial Service Providers	p. 78
Food and Drug Administration	p. 79
Clinical Trial Sponsor	p. 80
Contract Research Organizations	p. 83
Study Monitors	p. 84
Clinical Trial Site	p. 85
Site Management Organizations	p. 88
Institutional Review Board	p. 91
Research Participants	p. 92
Industry Trade Organizations and Support Services	p. 92
New Technologies for Discovery	p. 94
Remote Data Entry	p. 95
Electronic Data Capture	p. 96
Summary	p. 97
Best Practices	p. 97
Key Questions	p. 98
References	p. 100
Clinical Trial Implementation	p. 103
Evaluating the Clinical Trial Protocol	p. 104
Medical Perspective	p. 104
Resource Utilization Perspective	p. 106
Initiating the Clinical Trial Protocol	p. 111
Site Selection Visit	p. 111
Regulatory Compliance	p. 112
Negotiating Study Fees and Contract Terms	p. 112
Preparing for Clinical Trial Initiation	p. 113
Initiation Visit	p. 115
Executing the Clinical Trial Protocol	p. 117
Identifying and Recruiting Research Participants	p. 119
Obtaining Informed Consent and Screening Study Participants	p. 120
Enrolling Research Participants	p. 123
Following the Protocol	p. 125
Completing Case Report Forms	p. 127
Resolving Queries	p. 129
Closing Out the Clinical Trial	p. 129
Archiving Clinical Trial Documents	p. 130
Summary	p. 131
Best Practices	p. 132
Key Questions	p. 133
Reference	p. 134
Data Management	p. 135
The Role of the Sponsor/CRO	p. 136
Data Collection Methodology	p. 136
Data Collection Tools	p. 138
Case Report Forms	p. 138
Monitoring	p. 146
Data Checks and Analysis	p. 146
The Role of the Investigative Site	p. 146
Site Data Collection Tools	p. 146
Data Collection into Source Documents	p. 147
Data Transcription into Case Report Forms	p. 147
Query Resolution	p. 149
Document Storage	p. 150
Best Practices	p. 151
Key Questions	p. 151
Quality Management and FDA Readiness	p. 155
Quality Management	p. 156
Quality Assurance	p. 156
Quality Improvement	p. 159
Creating a Culture of Quality	p. 160
Ensuring FDA Readiness	p. 161
Preparing for an Audit	p. 162
FDA Regulations Governing Investigators	p. 163
Protecting the Subject	p. 164
Following the Protocol	p. 164
Control of the Investigational Product	p. 165
The Role of the IRB in Protecting Investigators	p. 166
The Inspection	p. 166
Inspector Profiles	p. 171
Case Study: An FDA Audit	p. 173
Best Practices	p. 175
Key Questions	p. 177
Reference	p. 178
The Research Participant	p. 179
Vignette: The Skeptic	p. 180
Recognizing and Working with the Skeptic	p. 181
Vignette: The Pleaser	p. 182
Recognizing and Caring for the Pleaser	p. 182
Vignette: The Information Seeker	p. 183
Recognizing and Supporting the Information Seeker	p. 184
Vignette: The Hopeless	p. 185
Enrolling the Terminally Ill	p. 185
Vignette: The Money Seeker	p. 186
Recognizing and Managing the Financially Motivated Participant	p. 186
Determining Reasonable Compensation	p. 187
Vignette: The Professional Research Participant	p. 188
Vignette: The High-Maintenance Participant	p. 189
Recognizing the High-Maintenance Participant	p. 190
Precautions for the High-Maintenance Participant	p. 191
Vignette: The Noncompliant Participant	p. 191
Recognizing Noncompliance	p. 192
Summary	p. 193
Best Practices	p. 193
Key Questions	p. 194
The Business of Clinical Research	p. 197
Evaluating and Negotiating Study Budgets	p. 198
Budgeting for Ancillary Services	p. 204
Budgeting for Coordinator Fees	p. 205
Budgeting for Patient Fees	p. 205
Budgeting for Principal Investigator Fees	p. 207
Budgeting for Quality Assurance	p. 207
Budgeting for Overhead	p. 208
Obtaining a Study Budget Total	p. 208
Negotiating the Study Budget	p. 209
Contracting with Sponsors, CROs, and Service Providers	p. 209
Relationships	p. 211
Intellectual Property	p. 211
Confidential Information	p. 212
Indemnification	p. 212
Publication	p. 213
Termination	p. 214
Payment Terms	p. 215
Funding Needs	p. 218
Managing Cash Flow	p. 221
Managing Accounts Payable	p. 223
Managing Accounts Receivable	p. 224
Income - Expenses = The Bottom Line	p. 227
Case Study: Managing the Growth	p. 228
Best Practices	p. 231
Key Questions	p. 232
The Clinical Research Site	p. 235
Prophet or Profit: Commitment and Motivation	p. 237
Clinical Trial Core Competencies	p. 238
Outpatient Research	p. 239
Inpatient Research	p. 240
Device Research	p. 242
Consumer Product Research	p. 243
Industry Affiliations	p. 244
Sponsor-Preferred Provider	p. 244
Site Management Organizations	p. 245
Clinical Trial Brokers	p. 246
Investigator Networks	p. 246
Key Clinical Research Personnel	p. 248
The Research Coordinator	p. 248
The Regulatory Affairs Manager	p. 249
The Research Assistant	p. 250
Investigator and Research Personnel Training	p. 251
Study-Specific Training	p. 251
Training as a Sub-Investigator	p. 251
Research Coordinator Training	p. 252
Standard Operating Procedures	p. 252
Humble Beginnings	p. 253
Acquiring the First Study	p. 253
Enrolling Research Participants	p. 254
Communication	p. 256
Marketing Research Services	p. 257
Predictors of Success	p. 257
Building Relationships	p. 257
Investigator Databases	p. 259
Ask for Feedback	p. 260
Best Practices	p. 260
Key Questions	p. 261
References	p. 262
Index	p. 265
Table of Contents provided by Rittenhouse. All Rights Reserved.

Amazon no longer offers textbook rentals. We do!

Clinical Research: What It Is and How It Works

Clinical Research: What It Is and How It Works

9780763731366

0763731366

Summary

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