Clinical Trials book cover

Clinical Trials

Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.

Audience

Pharmaceutical scientists and pharmacologists, medical writers and physicians, nurses and pharmacists who plan and conduct clinical trials.

Hardbound, 672 Pages

Published: November 2011

Imprint: Academic Press

ISBN: 978-0-12-391911-3

Reviews

  • "…A solid guide to designing clinical trials for medical scientists, especially those working in oncology, immune disease, and infectious disease…Three chapters address quality-of-life topics."  -Selected for The First Clinical Research Bookshelf, "Essential Reading for Clinical Research Professionals," Journal of Clinical Research Best Practices, September 2012, Vol. 8, No. 9


Contents

  • Abbreviations
    Introduction
    1. The Origins of Drugs
    2. Study Schema
    3. Run-in Period
    4. Inclusion and Stratification, Part I
    5. Inclusion and Stratification, Part II
    6. Blinding, Randomization, and Allocation
    7. Placebo
    8. Intent to Treat Versus Per Protocol
    9. Statistics
    10. Introduction to Endpoints for Clinical Trials in Pharmacology
    11. Oncology Endpoint: Objective Response
    12. Oncology Endpoint: Overall Survival and Progression-free Survival
    13. Oncology Endpoint: Time to Progression
    14. Oncology Endpoint: Disease-free Survival
    15. Oncology Endpoint: Time to Distant Metastasis
    16. Neoadjuvant Therapy Versus Adjuvant Therapy
    17. Hematological Cancers
    18. Biomarkers and Personalized Medicine
    19. Endpoints for Immune Diseases
    20. Endpoints for Infections
    21. Health-related Quality of Life for Oncology
    22. Health-related Quality of Life for Immune Disorders
    23. Health-related Quality of Life and Infections
    24. Drug Safety
    25. Mechanism of Action, Part I
    26. Mechanism of Action, Part II: Cancer
    27. Mechanism of Action, Part III: Immune Diseases
    28. Mechanism of Action, Part IV: Infections
    29. Consent Forms
    30. Package Inserts
    31. Regulatory Approval
    32. Patents

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