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Cancer Clinical Trials Proactive Strategies
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Book Synopsis Cancer Clinical Trials: Proactive Strategies by : Stanley P. L. Leong
Download or read book Cancer Clinical Trials: Proactive Strategies written by Stanley P. L. Leong and published by Springer Science & Business Media. This book was released on 2007-11-25 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309492319 Total Pages :175 pages Book Rating :4.3/5 (94 download)
Book Synopsis Guiding Cancer Control by : National Academies of Sciences, Engineering, and Medicine
Download or read book Guiding Cancer Control written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-08-30 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: Throughout history, perhaps no other disease has generated the level of social, scientific, and political discourse or has had the degree of cultural significance as cancer. A collective in the truest sense of the word, "cancer" is a clustering of different diseases that afflict individuals in different ways. Its burdens are equally broad and diverse, from the physical, financial, and psychological tolls it imposes on individuals to the costs it inflicts upon the nation's clinical care and public health systems, and despite decades of concerted efforts often referred to as the "war on cancer", those costs have only continued to grow over time. The causes and effects of cancer are complexâ€"in part preventable and treatable, but also in part unknown, and perhaps even unknowable. Guiding Cancer Control defines the key principles, attributes, methods, and tools needed to achieve the goal of implementing an effective national cancer control plan. This report describes the current structure of cancer control from a local to global scale, identifies necessary goals for the system, and formulates the path towards integrated disease control systems and a cancer-free future. This framework is a crucial step in establishing an effective, efficient, and accountable system for controlling cancer and other diseases.
Book Synopsis Improving the Quality of Cancer Clinical Trials by : Institute of Medicine
Download or read book Improving the Quality of Cancer Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2008-06-12 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would: (1) better inform decisions and plans of those responsible for developing new cancer therapies (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic (3) be less costly than current trials The resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward.
Book Synopsis Clinical Trials in Oncology, Third Edition by : Stephanie Green
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.
Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine
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.
Book Synopsis Strategies to Leverage Research Funding by : Institute of Medicine
Download or read book Strategies to Leverage Research Funding written by Institute of Medicine and published by National Academies Press. This book was released on 2004-10-27 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1992 the Department of Defense (DOD), through the U.S. Army Medical Research and Material Command, has received congressionally earmarked appropriations for programs of biomedical research on prostate, breast, and ovarian cancer; neurofibromatosis; tuberous sclerosis; and other health problems. Appropriations for these Congressionally Directed Medical Research Programs are used to support peer reviewed extramural research project, training, and infrastructure grants. Congress has become concerned about funding increases for these programs given current demands on the military budget. At the request of Congress, the Institute of Medicine (IOM) examined possibilities of augmenting program funding from alternative sources. The resulting IOM book, Strategies to Leverage Research Funding: Guiding DOD's Peer Reviewed Medical Research Programs, focuses on nonfederal and private sector contributions that could extend the appropriated funds without biasing the peer review project selection process.
Book Synopsis A National Cancer Clinical Trials System for the 21st Century by : Institute of Medicine
Download or read book A National Cancer Clinical Trials System for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2010-08-08 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Contemporary Issues for Protecting Patients in Cancer Research by : Institute of Medicine
Download or read book Contemporary Issues for Protecting Patients in Cancer Research written by Institute of Medicine and published by National Academies Press. This book was released on 2014-09-19 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges.
Book Synopsis Reinventing Patient Recruitment by : Joan F. Bachenheimer
Download or read book Reinventing Patient Recruitment written by Joan F. Bachenheimer and published by Gower Publishing, Ltd.. This book was released on 2007 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.
Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Academic Press. This book was released on 2017-11-17 with total page 824 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting
Book Synopsis Cancer Clinical Trials by : National Cancer Institute
Download or read book Cancer Clinical Trials written by National Cancer Institute and published by CreateSpace. This book was released on 2012-06-08 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Institutes of Health Publication 02-5053, Cancer Clinical Trials: A Resource Guide for Outreach, Education, and Advocacy, helps individuals and organizations find ways to participate and engage their community in clinical trials outreach and education activities. This publication includes worksheets and a Plan for Action to plan outreach efforts. Whether you are a health care professional who wants to find ways to reach your community, a member of a patient group who wants to educate its members, or someone who want to engage your group or organization to initiate clinical trial outreach activities. This guide is not designed to be a comprehensive overview; rather, it gives some examples of activities others have engaged in, and provides tools and suggestions for implantation in your community. By informing your community about clinical trials, you can help people make informed decisions about their cancer treatment or prevention options, including the option of participation in a clinical trial. The more people that participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment and prevention options for all cancers. This workbook is designed to complement the other materials in the National Cancer Institute Clinical Trials Education Series, described at the beginning of this book.~
Book Synopsis Success in Academic Surgery: Clinical Trials by : Timothy M. Pawlik
Download or read book Success in Academic Surgery: Clinical Trials written by Timothy M. Pawlik and published by Springer Science & Business Media. This book was released on 2013-11-04 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309457971 Total Pages :145 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Drug Development Paradigm in Oncology by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer
Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and published by . This book was released on 2006 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Phase I trials are the first step in the study of novel therapeutic approaches. They aim to identify the recommended dose, schedule and pharmacologic behavior of new drugs, and to describe the adverse effects of treatment. This practical guide discusses the design, conduct, analysis and ethical aspects of Phase I cancer trials.
Download or read book Cancer on Trial written by Peter Keating and published by University of Chicago Press. This book was released on 2011-12-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cancer on Trial written by Peter Keating and published by University of Chicago Press. This book was released on 2014-04-18 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
