Cancer Clinical Trials

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Transforming Clinical Research in the United States

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 151 pages
File Size : 40,8 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9780309163354

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Cancer Clinical Trials

Author : Stephen L. George,Xiaofei Wang,Herbert Pang
Publisher : CRC Press
Page : 474 pages
File Size : 53,7 Mb
Release : 2016-08-19
Category : Mathematics
ISBN : 9781498706902

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Cancer Clinical Trials by Stephen L. George,Xiaofei Wang,Herbert Pang Pdf

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Oncology Clinical Trials

Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
Publisher : Demos Medical Publishing
Page : 168 pages
File Size : 47,6 Mb
Release : 2009-12-22
Category : Medical
ISBN : 1935281763

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Oncology Clinical Trials by Susan Halabi, PhD,Wm. Kevin Kelly, DO Pdf

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

Cancer Clinical Trials

Author : Tomasz M. Beer,Larry Axmaker
Publisher : Diamedica
Page : 0 pages
File Size : 44,6 Mb
Release : 2012
Category : Cancer
ISBN : 098232197X

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Cancer Clinical Trials by Tomasz M. Beer,Larry Axmaker Pdf

A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones.

Randomized Phase II Cancer Clinical Trials

Author : Sin-Ho Jung
Publisher : CRC Press
Page : 244 pages
File Size : 42,7 Mb
Release : 2013-05-02
Category : Mathematics
ISBN : 9781439871867

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Randomized Phase II Cancer Clinical Trials by Sin-Ho Jung Pdf

In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy. Randomized Phase II Cancer Clinical Trials explains how to properly select and accurately use diverse statistical methods for designing and analyzing phase II trials. The author first reviews the statistical methods for single-arm phase II trials since some methodologies for randomized phase II trials stem from single-arm phase II trials and many phase II cancer clinical trials still use single-arm designs. The book then presents methods for randomized phase II trials and describes statistical methods for both single-arm and randomized phase II trials. Although the text focuses on phase II cancer clinical trials, the statistical methods covered can also be used (with minor modifications) in phase II trials for other diseases and in phase III cancer clinical trials. Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials. It provides readers with numerous statistical design and analysis methods for randomized phase II trials in oncology.

Landmark Trials in Oncology

Author : Santosh Yajnik
Publisher : Springer
Page : 325 pages
File Size : 53,5 Mb
Release : 2019-05-17
Category : Medical
ISBN : 9783030144050

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Landmark Trials in Oncology by Santosh Yajnik Pdf

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.

Phase I Cancer Clinical Trials

Author : Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse
Publisher : Oxford University Press
Page : 352 pages
File Size : 46,8 Mb
Release : 2015-03-20
Category : Medical
ISBN : 9780199359035

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Phase I Cancer Clinical Trials by Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse Pdf

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

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

Author : Takashi Daimon,Akihiro Hirakawa,Shigeyuki Matsui
Publisher : Springer
Page : 133 pages
File Size : 43,9 Mb
Release : 2019-05-21
Category : Medical
ISBN : 9784431555858

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Dose-Finding Designs for Early-Phase Cancer Clinical Trials by Takashi Daimon,Akihiro Hirakawa,Shigeyuki Matsui Pdf

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

Author : Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley
Publisher : CRC Press
Page : 266 pages
File Size : 45,6 Mb
Release : 2012-05-09
Category : Mathematics
ISBN : 9781439814482

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Clinical Trials in Oncology, Third Edition by Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley Pdf

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.

A National Cancer Clinical Trials System for the 21st Century

Author : Institute of Medicine,Board on Health Care Services,Committee on Cancer Clinical Trials and the NCI Cooperative Group Program
Publisher : National Academies Press
Page : 317 pages
File Size : 48,9 Mb
Release : 2010-07-08
Category : Medical
ISBN : 9780309157872

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A National Cancer Clinical Trials System for the 21st Century by Institute of Medicine,Board on Health Care Services,Committee on Cancer Clinical Trials and the NCI Cooperative Group Program Pdf

The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

The Prevention and Treatment of Missing Data in Clinical Trials

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 54,9 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Cancer Clinical Trials: Proactive Strategies

Author : Stanley P. L. Leong
Publisher : Springer Science & Business Media
Page : 326 pages
File Size : 53,7 Mb
Release : 2007-11-25
Category : Medical
ISBN : 9780387332253

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Cancer Clinical Trials: Proactive Strategies by Stanley P. L. Leong Pdf

Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group.

Clinical Trials in Ovarian Cancer

Author : Christine S. Walsh
Publisher : Rutgers University Press
Page : 337 pages
File Size : 54,5 Mb
Release : 2017-01-16
Category : Medical
ISBN : 9780813586496

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Clinical Trials in Ovarian Cancer by Christine S. Walsh Pdf

When a patient is diagnosed with a gynecological malignancy, she and her doctors must make urgent, high-risk decisions about her course of treatment. In selecting an appropriate plan of care, physicians must weigh the patient’s individual needs, the tumor’s specific characteristics, and the treatment’s potential side effects. Because there is no one-size-fits-all treatment solution, a plethora of clinical trials have been performed on ovarian cancer patients, but clinicians may struggle to keep up with this ever-growing body of research. Collecting and synthesizing research findings from a wide array of medical journal articles and book chapters, Clinical Trials in Ovarian Cancer provides physicians with an invaluable resource. Gynecologic oncologist Christine S. Walsh systematically outlines each of the seminal Phase III trials that have shaped the treatment of ovarian cancers, detailing the rationale for the trial, the patient population studied, treatment delivery methods, efficacy, toxicity, and trial conclusions. She provides a clear overview of established treatments, as well as still-controversial experimental approaches. The first book to organize this cutting-edge research into an easy-to-use reference, Clinical Trials in Ovarian Cancer should help medical personnel at all levels provide their patients with the highest standard of care.

Clinical Trials

Author : Tom Brody
Publisher : Academic Press
Page : 897 pages
File Size : 53,8 Mb
Release : 2016-02-19
Category : Medical
ISBN : 9780128042588

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Clinical Trials by Tom Brody Pdf

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

Cancer on Trial

Author : Peter Keating,Alberto Cambrosio
Publisher : University of Chicago Press
Page : 475 pages
File Size : 41,5 Mb
Release : 2014-04-18
Category : Medical
ISBN : 9780226143040

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Cancer on Trial by Peter Keating,Alberto Cambrosio Pdf

There were no medical oncologists until a few decades ago. In the early 1960s, not only were there no such specialists, many practitioners regarded the treatment of terminally-ill cancer patients with heroic courses of chemotherapy as highly questionable. Physicians loath to assign patients randomly to competing treatments also expressed their outright opposition to the randomized clinical trials that were then relatively rare. And yet today these trials form the basis of medical oncology. How did such a spectacular change occur? How did medical oncology move from a non-entity and in some regards a reviled practice to the central position it now occupies in modern medicine? Cancer on Trial answers these questions by exploring how practitioners established a new style of practice, at the center of which lies the cancer clinical trial.