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Cancer On Trial

Author: Peter Keating
Publisher: University of Chicago Press
ISBN: 0226428915
Size: 29.50 MB
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Until the early 1960s, cancer treatment consisted primarily of surgery and radiation therapy. Most practitioners then viewed the treatment of terminally ill cancer patients with heroic courses of chemotherapy as highly questionable. The randomized clinical trials that today sustain modern oncology were relatively rare and prompted stiff opposition from physicians, who were loath to assign patients randomly to competing treatments. Yet today these trials form the basis of medical oncology. How did such a spectacular change occur? How did medical oncology pivot from a nonentity and, in some regards, a reviled practice to the central position it now occupies in modern medicine? In Cancer on Trial Peter Keating and Alberto Cambrosio explore how practitioners established a new style of practice, at the center of which lies the cancer clinical trial. Far from mere testing devices, these trials have become full-fledged experiments that have redefined the practices of clinicians, statisticians, and biologists. Keating and Cambrosio investigate these trials and how they have changed since the 1960s, all the while demonstrating their significant impact on the progression of oncology. A novel look at the institution of clinical cancer research and therapy, this book will be warmly welcomed by historians, sociologists, and anthropologists of science and medicine, as well as clinicians and researchers in the cancer field.

Oncology Clinical Trials

Author: William Kevin Kelly, DO
Publisher: Springer Publishing Company
ISBN: 0826168736
Size: 17.50 MB
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The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Cancer Patients Cancer Pathways

Author: Carsten Timmermann
Publisher: Palgrave Macmillan
ISBN: 1137272074
Size: 10.95 MB
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The eleven essays in this volume examine cancer research and treatment as everyday practice in post-war Europe and North America. Rather than writing cancer's history as that of inevitable progress and obstacles overcome, these scholars emphasize how contingency, politics, and institutional interests have informed approaches to research and treatment. Focusing on the interface between individual patient trajectories and the evolving routines of research, therapy and care, the contributors bring together ethnographically-inflected historical and sociological observation with technically well-informed accounts of encounters between patients and professionals. The picture that emerges is one of cancers rather than Cancer, of patients rather than "The Patient," and of medical practices that are both experimental and routine. As cancer treatment has come to epitomize biomedicine, these essays speak to readers interested more broadly in understanding patients' experiences with large institutions, sophisticated technologies, and clinical research, and the way these experiences can shape treatment policies.

A Cancer Companion

Author: Ranjana Srivastava
Publisher: University of Chicago Press
ISBN: 022630664X
Size: 53.59 MB
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Each year, more than 1 and a half million Americans alone will hear the words “you have cancer.” These three small words inevitably signal dramatic changes for the rest of life, setting in motion a chain of events that are often unnecessarily plagued by confusion. For every one of these patients, and their families, Ranjana Srivastava offers an empathic and expert field guide to this uncharted terrain. With wisdom and warmth, Srivastava demystifies the labyrinthine world of the illness. What is cancer and how is it treated? Why isn't cancer always operable? How should diagnoses be shared with children? What is the best diet during and after treatment? How can pain be managed? These basic questions are often overrun by the complexity of the oncological world, and the limits of office visits and doctor schedules. This book then becomes an ideal companion, and portable patient advocate, that makes the experience of cancer diagnosis, treatment, and recovery comprehensible.

Clinical Trials In Oncology Third Edition

Author: Stephanie Green
Publisher: CRC Press
ISBN: 1439814481
Size: 54.39 MB
Format: PDF, Mobi
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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.

Caring For The Heart

Author: W Bruce Fye
Publisher: Oxford University Press
ISBN: 0199982376
Size: 12.55 MB
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This groundbreaking book weaves together three important themes. It describes major developments in the diagnosis and treatment of heart disease in the twentieth century, explains how the Mayo Clinic evolved from a family practice in Minnesota into one of the world's leading medical centers, and reveals how the invention of new technologies and procedures promoted specialization among physicians and surgeons. Caring for the Heart is written for general readers as well as health care professionals, historians, and policy analysts. Unlike traditional institutional or disease-focused histories, this book places individuals and events in national and international contexts that emphasize the interplay of medical, scientific, technological, social, political, and economic forces that have resulted in contemporary heart care. Patient stories and media perspectives are included throughout to help general readers understand the medical and technological developments that are described. The book is a synthetic study, but it is written so that readers may pick and choose the chapters of most interest to them. Another feature of the book is that readers may follow the stories without looking at the notes. Those who are interested in delving deeper into the main topics will find a wealth of carefully chosen references that offer greater detail and additional perspectives. The descriptions and interpretations that fill the book benefit from the fact that the author has been a practicing cardiologist and medical historian for almost four decades. This is mainly a twentieth-century story, but it begins earlier--before there were physicians who were identified as cardiologists and at a time when medical specialization was just emerging in America. The final chapter, which addresses present-day concerns about health care costs, counterbalances earlier ones that might be read as celebrations of new technologies.

Phase I Cancer Clinical Trials

Author: Elizabeth A. Eisenhauer
Publisher: Oxford University Press
ISBN: 0199359032
Size: 39.24 MB
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Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials 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

Adaptive Treatment Strategies In Practice Planning Trials And Analyzing Data For Personalized Medicine

Author: Michael R. Kosorok
Publisher: SIAM
ISBN: 1611974186
Size: 60.95 MB
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Personalized medicine is a medical paradigm that emphasizes systematic use of individual patient information to optimize that patient's health care, particularly in managing chronic conditions and treating cancer. In the statistical literature, sequential decision making is known as an adaptive treatment strategy (ATS) or a dynamic treatment regime (DTR). The field of DTRs emerges at the interface of statistics, machine learning, and biomedical science to provide a data-driven framework for precision medicine. The authors provide a learning-by-seeing approach to the development of ATSs, aimed at a broad audience of health researchers. All estimation procedures used are described in sufficient heuristic and technical detail so that less quantitative readers can understand the broad principles underlying the approaches. At the same time, more quantitative readers can implement these practices. This book provides the most up-to-date summary of the current state of the statistical research in personalized medicine; contains chapters by leaders in the area from both the statistics and computer sciences fields; and also contains a range of practical advice, introductory and expository materials, and case studies.

Handbook Of Statistics In Clinical Oncology Third Edition

Author: John Crowley
Publisher: CRC Press
ISBN: 143986201X
Size: 10.59 MB
Format: PDF, ePub
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Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

Contested Medicine

Author: Gerald Kutcher
Publisher: University of Chicago Press
ISBN: 0226465330
Size: 26.58 MB
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In the 1960s University of Cincinnati radiologist Eugene Saenger infamously conducted human experiments on patients with advanced cancer to examine how total body radiation could treat the disease. But, under contract with the Department of Defense, Saenger also used those same patients as proxies for soldiers to answer questions about combat effectiveness on a nuclear battlefield. Using the Saenger case as a means to reconsider cold war medical trials, Contested Medicine examines the inherent tensions at the heart of clinical studies of the time. Emphasizing the deeply intertwined and mutually supportive relationship between cancer therapy with radiation and military medicine, Gerald Kutcher explores post–World War II cancer trials, the efforts of the government to manage clinical ethics, and the important role of military investigations in the development of an effective treatment for childhood leukemia. Whereas most histories of human experimentation judge research such as Saenger’s against idealized practices, Contested Medicine eschews such an approach and considers why Saenger’s peers and later critics had so much difficulty reaching an unambiguous ethical assessment. Kutcher’s engaging investigation offers an approach to clinical ethics and research imperatives that lays bare many of the conflicts and tensions of the postwar period.