Clinical Trials Handbook: Design and Conduct

Clinical Trials Handbook: Design and Conduct

Author(s): Curtis L. Meinert

Published Online: 16 OCT 2012 08:25AM EST

Print ISBN: 9781118218464

Online ISBN: 9781118422878

DOI: 10.1002/9781118422878

About this Book

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.

Table of contents

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  1. Part I: General

  2. Part II: Design Specifications

  3. Part III: Funding

  4. Part IV: Treatment Groups/Treatment Administration

  5. Part V: Masking

  6. Part VI: Bias and Variance Control

  7. Part VII: Treatment Assignment/Randomization

  8. Part VIII: IRBs and Consents

  9. Part IX: Enrollment and Followup

  10. Part X: Sample Size

  11. Part XI: Data Collection and Processing

  12. Part XII: Study Centers

  13. Part XIII: Investigators/Study Staff

  14. Part XIV: Committees

  15. Part XV: Treatment Effects Monitoring

  16. Part XVI: Quality Control and Assurance

  17. Part XVII: Data Analysis

  18. Part XVIII: Publication/Presentation

  19. Part XIX: Policies

  20. Part XX: Adverse Events

  21. Part XXI: Miscellaneous

  22. Appendices

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