Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Download or read book Textbook of Clinical Trials in Oncology written by Susan Halabi and published by CRC Press. This book was released on 2019-04-24 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Download or read book Textbook of Clinical Trials written by David Machin and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

Download or read book Clinical Trials in Oncology Third Edition written by Stephanie Green and published by CRC Press. This book was released on 2012-05-09 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and published by Oxford University Press, USA. This book was released on 2014-06 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preceded by Phase I cancer clinical trials: a practical guide / Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse. 1st ed. 2006.

Download or read book Fast Facts Clinical Trials in Oncology written by A. Hackshaw and published by Karger Medical and Scientific Publishers. This book was released on 2020-12-18 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by leading experts, 'Fast Facts: Clinical Trials in Oncology' will enhance the reader’s ability to critically evaluate published evidence. Assuming little or no prior knowledge, the book sets out clearly the fundamental features of clinical trials. The key attributes of Phase I–III trials of pharmaceutical products are described, as are trials of surgical procedures, radiation therapy and advanced therapies. The processes and documentation required to set up and conduct a trial are outlined, and the authors describe how trial data and real-world evidence are used to improve care. Although this concise colorful book focuses on oncology, the principles apply equally to interventions in other areas of practice. It will prove invaluable to medical, pharmaceutical and allied health professionals who want, or need, an overview of how contemporary clinical trials are designed and conducted.

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Landmark Trials in Oncology written by Santosh Yajnik and published by Springer. This book was released on 2019-05-17 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the evolution of treatment in oncology through the lens of approximately 250 landmark clinical trials. The well-designed clinical trial is essential to the practice of medicine. There is no field that has embraced or been transformed more by the clinical trial than oncology. Each primary cancer site has a remarkable story that can be told through clinical trials. For example, patients who presented decades ago with soft tissue sarcoma of the extremities would invariably undergo limb amputation. The landmark National Cancer Institute study by Rosenberg et al. randomized patients to limb sparing surgery followed by adjuvant radiation therapy compared with limb amputation. This study helped change the standard of care by allowing most patients to retain their functioning limbs with an improvement in quality of life and no compromise in overall survival. Such major clinical trials for common malignancies including breast, prostate, lung, gastrointestinal, genitourinary, and gynecologic cancers are discussed. Because oncology is multidisciplinary, this book should be of interest for radiation oncologists, surgeons, medical oncologists, and other physicians interested in learning more about the landmark trials that have shaped oncology.

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Download or read book Manual for Clinical Trials Nursing written by Angela D. Klimaszewski and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The brand-new third edition of the Manual for Clinical Trials Nursing provides a more comprehensive guide for clinical trials nurses of all levels of experience and practice settings. With expanded content and reorganized chapters to facilitate location of desired content, the book covers topics ranging from history and fundamental information through protocol development and financial factors, recruitment and retention, clinical trial participants, and genetics and genomics to correlative trials, quality assurance, professional development, and international research efforts. Since clinical trials research is dynamic, the new edition directs the reader to pertinent websites where the most current information is available. -- Provided by publisher.

Download or read book Methods and Biostatistics in Oncology written by Raphael. L.C Araújo and published by Springer. This book was released on 2018-04-16 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces and discusses the most important aspects of clinical research methods and biostatistics for oncologists, pursuing a tailor-made and practical approach. Evidence-based medicine (EBM) has been in vogue in the last few decades, particularly in rapidly advancing fields such as oncology. This approach has been used to support decision-making processes worldwide, sparking new clinical research and guidelines on clinical and surgical oncology. Clinical oncology research has many peculiarities, including specific study endpoints, a special focus on survival analyses, and a unique perspective on EBM. However, during medical studies and in general practice, these topics are barely taught. Moreover, even when EBM and clinical cancer research are discussed, they are presented in a theoretical fashion, mostly focused on formulas and numbers, rather than on clinical application for a proper literature appraisal. Addressing that gap, this book discusses more practical aspects of clinical research and biostatistics in oncology, instead of relying only on mathematical formulas and theoretical considerations. Methods and Biostatistics in Oncology will help readers develop the skills they need to understand the use of research on everyday oncology clinical practice for study design and interpretation, as well to demystify the use of EBM in oncology.

Download or read book Textbook of Medical Oncology written by Franco Cavalli and published by CRC Press. This book was released on 2009-09-12 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: Effective care of the cancer patient increasingly involves systemic treatment, and as the range of available therapeutic agents continues to expand, the medical oncologist must be fully aware of the rationale for choosing specific drugs and combinations. Textbook of Medical Oncology, 4th edition, is written by a highly acclaimed list of internation

Download or read book Practical Medical Oncology Textbook written by Antonio Russo and published by Springer Nature. This book was released on 2021-10-06 with total page 1104 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook combines essential information on clinical cancer medicine with a guide to the latest advances in molecular oncology and tumor biology. Providing a systematic overview of all types of solid tumors, including epidemiology and cancer prevention, genetic aspects of hereditary cancers, differential diagnosis, typical signs and symptoms, diagnostic strategies and staging, and treatment modalities, it also discusses new and innovative cancer treatments, particularly targeted therapy and immunotherapy. Expert commentaries at the end of each chapter highlight key points, offer insights, suggest further reading and discuss clinical application using case descriptions. This textbook is an invaluable, practice-oriented tool for medical students just beginning their clinical oncology studies, as well as for medical oncology residents and young professionals.

Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

Download or read book Dose Finding Designs for Early Phase Cancer Clinical Trials written by Takashi Daimon and published by Springer. This book was released on 2019-05-21 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Practical Clinical Oncology written by Louise Hanna and published by Cambridge University Press. This book was released on 2015-11-19 with total page 625 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to clinical oncology, covering the main treatment modalities and diagnosis and treatment strategies for specific tumour types.