Clinical Trials Handbook: Design and Conduct

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John Wiley & Sons, Oct 10, 2012 - Reference - 600 pages
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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.


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Abbreviations and Designations
Treatment effects monitoring committee
Counting and analysis rules
Primary outcome Chapter15 Outcome measures Chapter 16 Design synopsis Part III Funding
Funding Initiative Chapter 22 Funding Period Chapter 23 Funding Budget
Funding Mode PartIV Treatment GroupsTreatment Administration
Data sharing Internal
Center types
Center requirements Part XIII InvestigatorsStudy Staff
Research groupInvestigators Part XIVCommittees Chapter 111 Key committees
Study chairvicechair
Executive committee members
Steering committee representation models
Treatment EffectsMonitoring

Study groups
Comparison group
Study treatments
Test treatments Chapter 29 Controlcomparison treatment Chapter 30 Placebo treatment
Sham treatment Chapter32 Treatment modality Chapter 33 Treatment schedule
Treatment compliance measures
Maskmasking Definitions
Drug masking procedure
Assignment methods Fixed vs adaptive
Consent Disclaimers and notifications
Startup design
Followup Method
Followup Length Chapter 75 Closeout design
Loss to followup Chapter 79 Study timetable
Exclusions from enrollment
Sample size Design
Fixed vs adaptive designs
Designed subgroup comparisons
Data Collection and Processing
Contact schedule Chapter 91 Examinationsvisits
Examinationclinic visitschedule Chapter 93 Data collection Chapter 94 Data collection Schedules and procedures
Data flow
Data processing procedures
Laboratory tests Chapter 98 Readings
Tissue repositories Chapter 100 Form design Principlesand procedures Chapter101 Time windowspecifications Chapter 102 Data entry design
Stopping rules and guidelines
Questions and answers
Treatment effects monitoring Questionsand answers
Quality Control and Assurance Chapter 130 Quality control and assurance procedures Chapter 131 Performance monitoring Chapter 132 Training pr...
Assurances andcertifications Chapter 134 Site visiting procedures
Audit procedures
Data Analysis
Analysis datasets
Analysis questions regarding study results publications Chapter 138 Frequentist vs Bayesian analysis Chapter 139 Final analysis Chapter 140 Subgro...
Presentation policy
Policies Chapter 147 Publicity policy
Policy on accessto study documents Chapter 149 Policy on access to study data and results
Policy on advertising for patients
Policy on incentive payments
Policy onpayment of patientrelated travel expenses Chapter 153 Ancillary study policy
Policy on patientcarerelated payments
Adverse events
Key study documents
Landmark events and dates
Design Summaries for SelectedFinished
CRRT CMV Retinitis Retreatment Trial 84
Template Summary Worksheet537

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About the author (2012)

CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical Trials. Dr. Meinert has focused his research on the methodological issues in clinical trials, including their design, conduct, policy, and practice. He is the author of Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition (Wiley).

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