Description
Book SynopsisThis is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing 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.
Table of ContentsLandmark Trials. - Procurement and Distributionof Study Medicines. - Budget Development. - Responsibilities and Management of the Coordinating Center. - Mechanics of Masking Investigators. - Dose Finding for Drug Combinations. - Adaptive Phase 2 Designs. - Estimands and Sensitivity Analysis. - Data Deidentification and Encryption. - Research Integrity Standards and Consequences of Violations
