Clinical Trials Handbook: Design and Conduct

ویرایش:  
نویسندگان: Curtis L. Meinert(auth.)  
سری:  
ISBN (شابک) : 9781118218464, 9781118422878 
ناشر:  
سال نشر: 2012 
تعداد صفحات: 491 
زبان: English 
فرمت فایل : PDF (درصورت درخواست کاربر به PDF، EPUB یا AZW3 تبدیل می شود) 
حجم فایل: 7 مگابایت 

قیمت کتاب (تومان) : 52,000

A systematic approach to all aspects of designing and conducting clinical trials

The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials?teaching them how to simplify the process and avoid costly mistakes.

The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include:

• Protocols for drug masking, controls, and treatment randomization
• Consent, enrollment, eligibility, and follow-up procedures
• Different types of sample size design and data collection and processing
• Working with study centers, research staff, and various committees
• Monitoring treatment effects and performance, and ensuring quality control
• Data analysis and access policies for study data and documents

Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.

Content:
Chapter 1 Terminology (pages 1–4):
Chapter 2 Definitions (page 5):
Chapter 3 Measurement Units (page 7):
Chapter 4 Trial Type (pages 9–11):
Chapter 5 Design and Flow Schematics (page 13):
Chapter 6 Design and Operating Principles (page 15):
Chapter 7 Counting and Analysis Rules (pages 17–18):
Chapter 8 Multi?Study Umbrella Name (pages 19–20):
Chapter 9 Study Name (pages 21–23):
Chapter 10 Objective (pages 25–28):
Chapter 11 Specific aims (page 29):
Chapter 12 Experimental Variable (page 31):
Chapter 13 Treatment Unit (pages 33–34):
Chapter 14 Primary Outcome (pages 35–37):
Chapter 15 Outcome Measures (pages 39–40):
Chapter 16 Design Synopsis (pages 41–44):
Chapter 17 Type of Funding Initiative (pages 45–48):
Chapter 18 Funding: Specifications (pages 49–50):
Chapter 19 Funding: Terminology (pages 51–57):
Chapter 20 Funding: Type (page 59):
Chapter 21 Funding: Initiative (pages 61–62):
Chapter 22 Funding: Period (page 63):
Chapter 23 Funding: Budget (pages 65–66):
Chapter 24 Funding: Mode (pages 67–68):
Chapter 25 Study Groups (pages 69–71):
Chapter 26 Comparison Group (pages 73–74):
Chapter 27 Study Treatments (pages 75–76):
Chapter 28 Test Treatments (pages 77–78):
Chapter 29 Control/Comparison Treatment (pages 79–85):
Chapter 30 Placebo Treatment (pages 87–90):
Chapter 31 Sham Treatment (pages 91–92):
Chapter 32 Treatment Modality (page 93):
Chapter 33 Treatment Schedule (pages 95–96):
Chapter 34 Treatment Compliance Measures (pages 97–99):
Chapter 35 Protocol Overrides (pages 101–102):
Chapter 36 Protocol Bailouts (pages 103–104):
Chapter 37 Mask/masking: Definitions (pages 105–109):
Chapter 38 Masking Principles (pages 111–112):
Chapter 39 Masking, Censoring, and Shielding Specifications (pages 113–114):
Chapter 40 Drug Masking Procedure (page 115):
Chapter 41 Drug Packaging and Labeling (pages 117–119):
Chapter 42 Drug Supply (pages 121–122):
Chapter 43 Masking Safeguards (page 123):
Chapter 44 Unmasking Treatment Assignment (page 125):
Chapter 45 Results Blackouts (pages 127–128):
Chapter 46 Bias Control Procedures (pages 129–133):
Chapter 47 Stratification (pages 135–137):
Chapter 48 Variance Control Procedures (pages 139–140):
Chapter 49 Separations (page 141):
Chapter 50 Assignment Methods: Fixed vs. Adaptive (pages 143–146):
Chapter 51 Treatment Assignment: Random vs. Nonrandom (pages 147–149):
Chapter 52 Randomization: Complete vs. Restricted (pages 151–153):
Chapter 53 Randomization Unit (pages 155–156):
Chapter 54 Randomization: Procedures (page 157):
Chapter 55 IRBs (pages 159–162):
Chapter 56 IRBs: Models and Procedures (pages 163–167):
Chapter 57 Consent (pages 169–175):
Chapter 58 Consent: Checklist (pages 177–179):
Chapter 59 Consent: Disclaimers and Notifications (pages 181–182):
Chapter 60 Consent: Principles and Purpose (page 183):
Chapter 61 Consent: Process (pages 185–187):
Chapter 62 Consent: Types (pages 189–190):
Chapter 63 Consent: Questions and Answers (pages 191–193):
Chapter 64 Notation (pages 195–198):
Chapter 65 Timing Conventions (pages 199–200):
Chapter 66 Required Approvals, Permissions, Accesses, and Supplies (pages 201–202):
Chapter 67 Start?Up Design (pages 203–205):
Chapter 68 Start?Up Checklist (page 207):
Chapter 69 Recruitment Design (pages 209–210):
Chapter 70 Enrollment Goals (pages 211–212):
Chapter 71 Enrollment Quotas (pages 213–216):
Chapter 72 Followup: Terminology (pages 217–219):
Chapter 73 Followup: Method (pages 221–222):
Chapter 74 Followup: Length (page 223):
Chapter 75 Closeout Design (pages 225–227):
Chapter 76 Missed Visit (page 229):
Chapter 77 Dropout (pages 231–234):
Chapter 78 Loss to Followup (pages 235–237):
Chapter 79 Study Timetable (page 239):
Chapter 80 Critical Event Path Analysis (pages 241–242):
Chapter 81 Eligibility Criteria (pages 243–244):
Chapter 82 Exclusions from Enrollment (pages 245–248):
Chapter 83 Eligibility and Exclusions by Reason (pages 249–250):
Chapter 84 Sample Size: Design (pages 251–255):
Chapter 85 Sample Size: Specifications (pages 257–258):
Chapter 86 Sample Size: Calculation (pages 259–260):
Chapter 87 Fixed vs. Sequential Sample Size Designs (page 261):
Chapter 88 Fixed vs. Adaptive Designs (pages 263–264):
Chapter 89 Designed Subgroup Comparisons (pages 265–266):
Chapter 90 Contact Schedule (pages 267–269):
Chapter 91 Examinations/Visits (pages 271–274):
Chapter 92 Examination/Clinic Visit Schedule (pages 275–277):
Chapter 93 Data Collection (pages 279–280):
Chapter 94 Data Collection: Schedules and Procedures (pages 281–282):
Chapter 95 Data Flow (pages 283–284):
Chapter 96 Data Processing Procedures (pages 285–286):
Chapter 97 Laboratory Tests (pages 287–288):
Chapter 98 Readings (pages 289–291):
Chapter 99 Tissue Repositories (pages 293–294):
Chapter 100 Form Design: Principles and Procedures (pages 295–298):
Chapter 101 Time Window Specifications (pages 299–300):
Chapter 102 Data Entry Design (pages 301–306):
Chapter 103 Data Sharing: Internal (pages 307–309):
Chapter 104 Data Sharing: External (pages 311–314):
Chapter 105 Center Types (pages 315–321):
Chapter 106 Centers (pages 323–324):
Chapter 107 Center Requirements (pages 325–327):
Chapter 108 Investigator Requirements (pages 329–332):
Chapter 109 Clinic Staffing Requirements (page 333):
Chapter 110 Research Group/Investigators (pages 335–336):
Chapter 111 Key Committees (pages 337–339):
Chapter 112 Standing and Working Committees (page 341):
Chapter 113 Committee Rules and Procedures (pages 343–346):
Chapter 114 Study Officers (page 347):
Chapter 115 Study Chair/Vice?Chair (pages 349–352):
Chapter 116 Executive Committee (pages 353–355):
Chapter 117 Executive Committee Members (page 357):
Chapter 118 Steering Committee (pages 359–360):
Chapter 119 Steering Committee Members (pages 361–362):
Chapter 120 Steering Committee: Questions, Answers, and Observations (pages 363–365):
Chapter 121 Steering Committee Representation Models (pages 367–370):
Chapter 122 Treatment Effects Monitoring (pages 371–374):
Chapter 123 Treatment Effects Monitoring: Purpose (pages 375–376):
Chapter 124 Treatment Effects Monitoring: Approach (pages 377–378):
Chapter 125 Treatment Effects Monitoring: Masking (pages 379–380):
Chapter 126 Stopping Rules and Guidelines (pages 381–382):
Chapter 127 Treatment Effects Monitoring: Questions and Answers (pages 383–385):
Chapter 128 Treatment Effects Monitoring Committee (pages 387–389):
Chapter 129 Treatment Effects Monitoring Committee: Questions and Answers (pages 391–392):
Chapter 130 Quality Control and Assurance Procedures (pages 393–398):
Chapter 131 Performance Monitoring (pages 399–400):
Chapter 132 Training Procedures (page 401):
Chapter 133 Assurances and Certifications (pages 403–404):
Chapter 134 Site Visiting Procedures (pages 405–407):
Chapter 135 Audit Procedures (pages 409–411):
Chapter 136 Analysis Datasets (pages 413–415):
Chapter 137 Analysis Questions Regarding Study Results Publications (pages 417–418):
Chapter 138 Frequentist vs. Bayesian Analysis (pages 419–420):
Chapter 139 Final Analysis (pages 421–422):
Chapter 140 Subgroup Analysis (pages 423–424):
Chapter 141 Publication (pages 425–428):
Chapter 142 Publication Policy (pages 429–430):
Chapter 143 Authorship (pages 431–434):
Chapter 144 Credits (pages 435–438):
Chapter 145 Presentation Policy (pages 439–440):
Chapter 146 Policies (pages 441–443):
Chapter 147 Publicity Policy (page 445):
Chapter 148 Policy on Access to Study Documents (pages 447–448):
Chapter 149 Policy on Access to Study Data and Results (pages 449–451):
Chapter 150 Policy on Advertising for Patients (page 453):
Chapter 151 Policy on Incentive Payments (pages 455–456):
Chapter 152 Policy on Payment of Patient?Related Travel Expenses (page 457):
Chapter 153 Ancillary Study Policy (pages 459–460):
Chapter 154 Policy on Patient?Care?Related Payments (page 461):
Chapter 155 Policy on Conflicts of Interest (pages 463–465):
Chapter 156 Substudy Policy (page 467):
Chapter 157 Adverse Events (pages 469–474):
Chapter 158 Adverse Event Reporting Procedures (pages 475–477):
Chapter 159 Key Study Documents (pages 479–481):
Chapter 160 Design Synopsis (page 483):
Chapter 161 Slide Sets (page 485):
Chapter 162 Study CV (page 487):
Chapter 163 Study Website (page 489):
Chapter 164 Study History Log (pages 491–492):
Chapter 165 Landmark Events and Dates (page 493):
Chapter 166 Registration (page 495):