Phase I Cancer Clinical Trials - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Phase I Cancer Clinical Trials write by Elizabeth A. Eisenhauer. This book was released on 2014-06. Phase I Cancer Clinical Trials available in PDF, EPUB and Kindle. Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials.
Dose-Finding Designs for Early-Phase Cancer Clinical Trials
Dose-Finding Designs for Early-Phase Cancer Clinical Trials - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Dose-Finding Designs for Early-Phase Cancer Clinical Trials write by Takashi Daimon. This book was released on 2019-05-21. Dose-Finding Designs for Early-Phase Cancer Clinical Trials available in PDF, EPUB and Kindle. This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.
Clinical Trials in Oncology, Third Edition
Clinical Trials in Oncology, Third Edition - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Clinical Trials in Oncology, Third Edition write by Stephanie Green. This book was released on 2012-05-09. Clinical Trials in Oncology, Third Edition available in PDF, EPUB and Kindle. The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.
Transforming Clinical Research in the United States
Transforming Clinical Research in the United States - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Transforming Clinical Research in the United States write by Institute of Medicine. This book was released on 2010-10-22. Transforming Clinical Research in the United States available in PDF, EPUB and Kindle. An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Novel Designs of Early Phase Trials for Cancer Therapeutics
Novel Designs of Early Phase Trials for Cancer Therapeutics - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Novel Designs of Early Phase Trials for Cancer Therapeutics write by Shivaani Kummar. This book was released on 2018-05-22. Novel Designs of Early Phase Trials for Cancer Therapeutics available in PDF, EPUB and Kindle. Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development
