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Developing a Successful Clinical Research Program

  • Book
  • © 2018

Overview

Authors:
  1. Cara East

    1. Baylor Soltero CV Research, Baylor University Medical Center, Dallas, USA

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  • The first book of its kind discussing how to develop a successful team approach to clinical research

  • Covers launching, performing and completing the study, with tips on team building and patient selection and retention

  • Practical and user-friendly in all clinical settings

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Table of contents (22 chapters)

  1. Front Matter

    Pages i-xix
    Download chapter PDF

  2. Why Do Clinical Research?

    • Cara East
    Pages 1-10

  3. How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect

    • Cara East
    Pages 11-18

  4. Choosing a Study

    • Cara East
    Pages 19-25

  5. Starting a Clinical Research Team

    • Cara East
    Pages 27-36

  6. Developing a Budget

    • Cara East
    Pages 37-44

  7. Negotiating a Contract

    • Cara East
    Pages 45-52

  8. Writing a Great Consent

    • Cara East
    Pages 53-62

  9. Starting the Study

    • Cara East
    Pages 63-67

  10. Institutional Review Board (IRB)

    • Cara East
    Pages 69-76

  11. Recruiting

    • Cara East
    Pages 77-82

  12. Getting Subjects Through the Door

    • Cara East
    Pages 83-88

  13. The Screening Visit

    • Cara East
    Pages 89-99

  14. Follow-Up Subject Visits

    • Cara East
    Pages 101-107

  15. Maintaining Subject Retention and Avoiding Study Fatigue

    • Cara East
    Pages 109-118

  16. Adverse Events and Protocol Deviations

    • Cara East
    Pages 119-125

  17. Contract Research Organizations and Monitors

    • Cara East
    Pages 127-135

  18. Annual Reviews and Financial Disclosures

    • Cara East
    Pages 137-144

  19. Finishing the Study

    • Cara East
    Pages 145-148

  20. Staff Training and Incentives

    • Cara East
    Pages 149-162
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Keywords

About this book

This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit.



Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field.

Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting. 

Reviews

‘”Developing a Successful Clinical Research Program’ is a compact but comprehensive primer for the new investigator or clinical research site. The book includes practical, clearly written material, such as the beginning of the chapter on starting a clinical research team.” (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 15 (2), February, 2019)

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Authors and Affiliations

  • Baylor Soltero CV Research, Baylor University Medical Center, Dallas, USA

    Cara East

About the author

Cara East, MD, FACP, Texas Heart Center, Director, Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX, USA

Bibliographic Information

  • Book Title: Developing a Successful Clinical Research Program

  • Authors: Cara East

  • DOI: https://doi.org/10.1007/978-3-319-54693-3

  • Publisher: Springer Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer International Publishing AG, part of Springer Nature 2018

  • Softcover ISBN: 978-3-319-54692-6Published: 20 August 2018

  • eBook ISBN: 978-3-319-54693-3Published: 08 August 2018

  • Edition Number: 1

  • Number of Pages: XIX, 270

  • Number of Illustrations: 8 b/w illustrations, 2 illustrations in colour

  • Topics: Medicine/Public Health, general

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