Clinical Trials Reference from C.H.I.P.S.

Clinical Trials Handbook
edited by Shayne Cox Gad

Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials.

Chapters cover every key aspect of preparing and conducting clinical trials, including:

  • Interdisciplinary topics that have to be coordinated for a successful clinical trial
  • Data management (and adverse event reporting systems)
  • Biostatistics, pharmacology, and toxicology
  • Modeling and simulation
  • Regulatory monitoring and ethics
  • Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more
With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.


  1. Introduction to Clinical Trials
  2. Regulatory Requirements for Investigational New Drug
  3. Preclinical Assessment of Safety in Human Subjects
  4. Predicting human adverse drug reactions from non-clinical safety studies
  5. History of Clinical Trial Development and the Pharmaceutical Industry
    • Adaptive Research
  6. Organization and Planning
  7. The Process of Data Management
  8. Clinical Trials Data Management
  9. Clinical Trials and the FDA
    • Phase I Clinical Trials
    • Phase II Clinical Trials
    • Designing and Conducting Phase III Studies
    • Phase IV
    • Phase IV and Post Marketing Clinical Trials
    • Regulatory Approval
    • A New Paradigm for Analyzing Adverse Drug Events
  10. Clinical Trials in Interventional Cardiology: Focus on the XIENCE Drug-Eluting Stent (Doostzadeh J, Bezenek S, Cheong W-F, Sood P, Schwartz L, Sudhir K).
    • Clinical Trials Involving Oral Diseases
    • Dermatology Clinical Trials
    • Emergency Clinical Trials
    • Gastroenterology
    • Gynaecology Randomised Control Trials
    • Special Population Studies (Healthy Patient Studies)
    • Musculoskeletal
    • Oncology
    • Pharmacological Treatment Options for Non-exudative and exudative age-related macular degeneration
    • Paediatrics
    • Dementia
    • Clinical Trials in Urology
    • Clinical Trials on Cognitive Drugs
    • Bridging Studies in Pharmaceutical Safety Assessment
    • A Brief History of Clinical Trials on Vaccines
  11. Methods of Randomization
  12. Randomized Controlled Trials
  13. Cross-Over Designs
  14. Biomarkers
    • Biomarkers in clinical drug development: parallel analysis of Alzheimer Disease and Multiple Sclerosis
  15. Review Boards
  16. Size of Clinical Trials
  17. Blinding and Placebo
  18. Pharmacology
  19. Modeling and Simulation in Clinical Drug Development
  20. Monitoring
  21. Inference Following a Sequential Clinical Trial
  22. Statistical methods for Analysis of Clinical Trials
  23. Explanatory and Pragmatic Clinical Trials
  24. Ethics of Clinical Research in Durg Trials
    • Ethical Issues in Clinical Research
  25. Regulations
  26. Future Challenges in the Design and Ethics of Clinical Trials
  27. Proof-of-Principle/Proof-of-Concept trials in Drug Development

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Clinical Trials Handbook
edited by Shayne Cox Gad
2009 • 1,225 pages • $194.00 + shipping
Texas residents please add 6.75 % sales tax

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