Principles and Practice of Clinical Trials
Principles and Practice of Clinical Trials - Department of Surgery Division of Surgical Oncology Brigham and Women’s Hospital Harvard Medical School Boston, MA, USA | Springer Nature Switzerland AG | 2022 - 2573 Pages Includes Index
This 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.
978-3-319-52635-5 978-3-319-52636-2 (eBook) = activities adverse events allocation analysis applicable appropriate approval assessment bias cancer CFR Clin clinical center clinical research clinical sites ClinicalTrials.gov committee conduct coordinating center CRF data collection data management data monitoring committees database disease documents DSMB electronic endpoints enrollment ensure ethical European Medicines Agency evaluation example FDA follow-up Food and Drug funder funding GCP guidance guidelines Health human subjects identify implementation informed consent Institutional Review Boards institutions intervention investigational product investigators involved IRB key masking Medicine Meinert methods multicenter trials multiple patient-reported outcomes patients phase placebo population potential primary outcome procedures randomization recruitment registration regulations regulatory reporting responsible risk sample selection bias specific sponsor staff standard statistical study participants SWOG therapy treatment assignment treatment effect treatment groups trial data trial design trial participants trial protocol type I error USA visits
--Biomathematics, Biometry, Mathematics / Applied, Mathematics / Probability & Statistics / General, Mathematics / Probability & Statistics / Stochastic Processes, Medical / Biostatistics, Medical / General, Science / Life Sciences / General, Clinical trials.