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  • © 2020

Clinical Trials

  • Provides practical guidance on developing a career within surgical education
  • Covers how to develop a successful research team
  • Features information on all aspects of clinical trials, from trial design and building a research team, to statistics and getting trials published

Part of the book series: Success in Academic Surgery (SIAS)

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Table of contents (20 chapters)

  1. Front Matter

    Pages i-vi
  2. The History of Clinical Trials

    • Janice Hu, Justin Barr, Georgia M. Beasley
    Pages 1-15
  3. Ethics (Informed Consent and Conflicts of Interest)

    • Kara K. Rossfeld, Jordan M. Cloyd, Elizabeth Palmer, Timothy M. Pawlik
    Pages 17-31
  4. Trial Design: Overview of Study Designs

    • Puneet Singh, Yu Shen, Kelly K. Hunt
    Pages 37-45
  5. Defining the Study Cohort: Inclusion and Exclusion Criteria

    • Emily Z. Keung, Lisa M. McElroy, Daniela P. Ladner, Elizabeth G. Grubbs
    Pages 47-58
  6. Pragmatic Trials and Approaches to Transforming Care

    • Peter G. Stock, Rita Mukhtar, Hila Ghersin, Allison Stover Fiscalini, Laura Esserman
    Pages 59-76
  7. Clinical Trials: Ensuring Quality and Standardization

    • Mihir M. Shah, Darren R. Carpizo
    Pages 77-85
  8. Statistics: Setting the Stage

    • M. Abdullah Arain, Adil H. Haider, Zain G. Hashmi
    Pages 101-115
  9. Clinical Trials: Handling the Data

    • Douglas S. Swords, Benjamin S. Brooke
    Pages 117-135
  10. Data Safety Monitoring Boards

    • Rachael A. Callcut
    Pages 137-142
  11. Planning for Data Monitoring and Audits

    • Benjamin K. Poulose
    Pages 143-149
  12. The Budget

    • Shuab Omer, Faisal G. Bakaeen
    Pages 151-166
  13. Regulatory Considerations in Human Subjects Research

    • H. Richard Alexander Jr., Howard S. Hochster
    Pages 167-179
  14. Publishing Your Clinical Trial

    • Warren Gasper, Michael Conte
    Pages 181-186
  15. Pragmatic Clinical Trials

    • Peter C. Minneci, Katherine J. Deans
    Pages 187-194
  16. Cooperative Clinical Trials

    • Casey J. Allen, Giampaolo Perri, Matthew H. G. Katz
    Pages 195-212
  17. International Trials: Surgical Research Networks

    • Marc A. Gladman
    Pages 213-228
  18. Inclusion of Patient-Reported Outcomes in Clinical Trials

    • Lindsey M. Zhang, Cord Sturgeon, Anthony D. Yang, Ryan P. Merkow
    Pages 229-236

About this book

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. 

Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.


Editors and Affiliations

  • Chair, Department of Surgery The Urban Meyer III and Shelley Meyer Chair for Cancer Research, The Ohio State University Wexner Medical, Columbus, USA

    Timothy M. Pawlik

  • Leon Goldman, MD Distinguished Professor of Surgery and Chair Department of Surgery, University of California, San Francisco, San Francisco, USA

    Julie A. Sosa

About the editors

Dr. Pawlik is the Chair of Surgery at The Ohio State University Wexner Medical Center where he holds The Urban Meyer III and Shelley Meyer Chair for Cancer Research. Dr. Pawlik has given over 450 invited talks both nationally and internationally in 30 different countries. Dr. Pawlik has published over 1,000 articles and 90 book chapters, in addition to editing eight surgical textbooks. His research has been cited close to 40,000 times with an H-index of 100. Dr. Pawlik serves on multiple editorial boards and is Editor-in-Chief of Journal of Gastrointestinal Surgery, Deputy Editor of JAMA Surgery, as well as an Associate Editor for Annals of Surgical Oncology. Dr. Pawlik is a past-President of the Association for Academic Surgery, as well as the current President-elect of the Americas Hepato-Pancreato-Biliary Association. Dr. Pawlik’s international contributions have been recognized through his honorary memberships in the Royal Australasian College of Surgeons, Brazilian Society of Surgical Oncology, Mexican Association for Surgery of the Alimentary Tract, as well as the Society of General Surgeons of Perú and the Peruvian International Hepato-Pancreatobiliary Association. Dr. Pawlik received his BA from Georgetown University, MD at Tufts University, and then went on for advancing training in surgical oncology at MD Anderson Cancer Center.  Dr. Pawlik also received a Masters in Theology from Harvard Divinity School a PhD from the Johns Hopkins Bloomberg School of Public Health in Clinical Investigations.

Julie Ann Sosa, MD, MA is the Leon Goldman MD Distinguished Professor of Surgery and Chair of the Department of Surgery at the University of California San Francisco (UCSF), where she is also a Professor in the Department of Medicine and affiliated faculty for the Philip R. Lee Institute for Health Policy Studies. Her clinical interest is in endocrine surgery, with a focus in thyroid cancer. She is an NIH-funded investigator and author of more than 300 peer-reviewed publications, 2 books, and 50 book chapters, largely focused on outcomes research, health care delivery, hyperparathyroidism, and thyroid cancer, with a focus on clinical trials. Dr Sosa is Treasurer of the American Thyroid Association (ATA) and serves on the Board of Directors/Executive Council of the ATA and International Thyroid Oncology Group, as well as practice guidelines committees for the ATA, NCCN, and the American Association of Endocrine Surgeons. She is the Editor-in-Chief of the World Journal of Surgery and is an editor of Greenfield’s Surgery: Scientific Principles and Practice. She has mentored more than 70 students, residents, and fellows. Dr Sosa received her AB at Princeton, MA at Oxford, and MD at Johns Hopkins, where she completed the Halsted residency and a fellowship.

Bibliographic Information

  • Book Title: Clinical Trials

  • Editors: Timothy M. Pawlik, Julie A. Sosa

  • Series Title: Success in Academic Surgery

  • DOI: https://doi.org/10.1007/978-3-030-35488-6

  • Publisher: Springer Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer Nature Switzerland AG 2020

  • Softcover ISBN: 978-3-030-35487-9Published: 11 March 2020

  • eBook ISBN: 978-3-030-35488-6Published: 10 March 2020

  • Series ISSN: 2194-7481

  • Series E-ISSN: 2194-749X

  • Edition Number: 2

  • Number of Pages: VI, 258

  • Number of Illustrations: 10 b/w illustrations, 16 illustrations in colour

  • Topics: Surgery, Medical Education

Buy it now

Buying options

eBook USD 54.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 69.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access