Principles and Practice of Clinical Trials

1. Confident Statistical Inference with Multiple Outcomes, Subgroups, and Other Issues of Multiplicity

   • Siyoen Kil, Eloise Kaizar, Szu-Yu Tang, Jason C. Hsu

2. Consent Forms and Procedures

   • Ann-Margret Ervin, Joan B. Cobb Pettit

3. CONSORT and Its Extensions for Reporting Clinical Trials

   • Sally Hopewell, Isabelle Boutron, David Moher

4. Contracts and Budgets

   • Eric Riley, Eleanor McFadden

5. Controlling Bias in Randomized Clinical Trials

   • Bruce A. Barton

6. Controlling for Multiplicity, Eligibility, and Exclusions

   • Amber Salter, J. Philip Miller

7. Cross-over Trials

   • Byron Jones

8. Data and Safety Monitoring and Reporting

   • Sheriza Baksh, Lijuan Zeng

9. Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials

   • Kristin Knust, Lauren Yesko, Ashley Case, Kate Bickett

10. Data Sharing and Reuse

    • Ida Sim

11. De-identifying Clinical Trial Data

    • Jimmy Le

12. Design and Development of the Study Data System

    • Steve Canham

13. Designs to Detect Disease Modification

    • Michael P. McDermott

14. Development and Validation of Risk Prediction Models

    • Damien Drubay, Ben Van Calster, Stefan Michiels

15. Device Trials

    • Heng Li, Pamela E. Scott, Lilly Q. Yue

16. Diagnostic Trials

    • Madhu Mazumdar, Xiaobo Zhong, Bart Ferket

17. Documentation: Essential Documents and Standard Operating Procedures

    • Eleanor McFadden, Julie Jackson, Jane Forrest

18. Dose Finding for Drug Combinations

    • Mourad Tighiouart

19. Dose-Finding and Dose-Ranging Studies

    • Mark R. Conaway, Gina R. Petroni

20. Efficient Management of a Publicly Funded Cancer Clinical Trials Portfolio

    • Catherine Tangen, Michael LeBlanc

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the analysis and interpretation of scientific data gleaned from the trial process, a broad spectrum of clinical trial principles and practice areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy cannot be guaranteed and regulated without the Clinical Trials process. Because of an immense and continuing to grow international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time.

Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas:

1) Clinical Trials Basic Perspectives
2) Regulation and Oversight
3) Basic Trial Designs
4) Advanced Trial Designs
5) Analysis
6) Trial Publication
7) Topics Related Specific Populations and Legal Aspects of Clinical Trials


The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

• clinical trials
• clinical trial; design and analysis
• randomized clinical trials
• adaptive clinical trials
• data analysis
• biostatistics
• diagnostic trials
• screening trials
• observational studies

   

• Samuel Oschin Comprehensive Cancer Insti, WEST HOLLYWOOD, USA

  Steven Piantadosi

• Bloomberg School of Public Health, Johns Hopkins Center for Clinical Trials Bloomberg School of Public Health, Baltimore, USA

  Curtis L. Meinert

Steven Piantadosi is Director at the Samuel Oschin Cancer Institute at the Cedars-Sinai Medical Center at the University of California.
Curtis Meinert is a professor of Epidemiology at Johns Hopkins Center for Clinical Trials and Evidence Synthesis.
 

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