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Clinical Research will provide you with a fundamental, yet comprehensive, understanding of all phases of the clinical research process. It is ideal for those new to the field seeking a basic understanding of the entire clinical research process, as well as students of the health care professions who may conduct clinical research in their future careers.

Tabla de contenidos provista por Syndetics

• Preface(p. xv)
• Acknowledgments(p. xxi)
• Chapter 1 Testing Treatments in Humans(p. 1)
• Testing Drugs in Humans(p. 2)
• Phase I (p. 3)
• Phase II (p. 6)
• Phase III (p. 7)
• Phase IV (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)
• Chapter 2 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)
• Chapter 3 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)
• Chapter 4 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)
• Chapter 5 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)
• Chapter 6 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)
• Chapter 7 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)
• Chapter 8 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)
• Chapter 9 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)

Notas de autor provistas por Syndetics

Dr. Nesbitt is the Founder and Chief Executive Officer of Discovery Alliance International, Inc. Dr. Nesbitt received her Pharm.D. degree from Purdue University and her MBA from Tulane University. Discovery Alliance International, Inc., founded in 1996, is a dream come true for Dr. Nesbitt as it combines her entrepreneurial spirit with her love of research. The mission of Discovery Alliance is to provide community-based physicians, hospitals, and patients access to investigational therapies. Colleagues often ask Dr. Nesbitt what gave her the courage to leave a "safe" academic position to start her own business. Her response was: expertise in the industry, blind faith, and a solid plan B. Dr. Nesbitt is also the mother of two. Thus, the saying must betrue, "the more you do, the more you do?"