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Clinical Trials In Early Breast Cancer
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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 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 WHO List of Priority Medical Devices for Cancer Management by : World Health Organization
Download or read book WHO List of Priority Medical Devices for Cancer Management written by World Health Organization and published by . This book was released on 2017-05-09 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the model list and clearing house of appropriate, basic, and priority medical devices based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring, and end of life care. This publication addresses medical devices that can be used for the management of cancer and specifically describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung, and prostate. This book is intended for ministries of health, public health planners, health technology managers, disease management, researchers, policy makers, funding, and procurement agencies and support and advocacy groups for cancer patients.
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 2010-07-08 with total page 317 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 Targeted Therapies in Breast Cancer by : Gw Sledge
Download or read book Targeted Therapies in Breast Cancer written by Gw Sledge and published by Clinical Pub. This book was released on 2012-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new volume updates the reader on selected areas of targeted therapy in breast cancer, with special emphasis on chemoprevention strategies, drug resistance, biomarkers, combination chemotherapy, angiogenesis inhibition and pharmacogenomics in the context of clinical efficacy. This selected review of targeted therapies will guide the reader on effective treatment as part of an integrated programme of patient management.
Book Synopsis Preoperative (Neoadjuvant) Chemotherapy by : Joseph Ragaz
Download or read book Preoperative (Neoadjuvant) Chemotherapy written by Joseph Ragaz and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite recent advances in adjuvant therapies of cancer, the regi mens of postoperative adjuvant chemotherapy treatment which are presently available fail to cure the majority of cancer patients. Pre operative (neoadjuvant) chemotherapy represents a new approach in drug scheduling, based on sound theoretical, pharmacokinetic, and experimental principles. The preoperative timing of chemotherapy before definitive sur gery is not a minor change in the therapy of cancer. To be successful, large numbers of practitioners and their patients must participate. Substantial alterations of many aspects of the present management of cancer will have to follow. Therefore, before such therapy can be fully and routinely implemented, results of the novel treatment and its rationale have to be carefully evaluated. In preoperative treatment, other features will likely gain impor tance. For the first time, clinicians have a chance to follow the in vivo response of the tumor exposed to preoperative chemotherapy. The subsequent histological assessment of the tumor sample may likely become an important prognostic guide, permitting more re fined individual approaches to the planning of postoperative adju vant treatment. The value of such a treatment strategy can already be appreciated in the clinical setting, as seen from the therapy of osteosarcoma. Furthermore, preoperative chemotherapy might render previously inoperable tumors operable and hence resectable with a curative intention. The preoperative reduction of tumor bulk may also effectively decrease the need for more radical operations, permitting a more uniform adoption of conservative surgery.
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Book Synopsis Cancer Incidence and Survival Among Children and Adolescents by :
Download or read book Cancer Incidence and Survival Among Children and Adolescents written by and published by . This book was released on 1999 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 236 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.
Book Synopsis Management of Early Stage Breast Cancer by : Beena Kunheri
Download or read book Management of Early Stage Breast Cancer written by Beena Kunheri and published by Springer Nature. This book was released on 2020-10-01 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Breast cancer, its causes, early detection and treatment have received considerable attention, since this widespread disease is one of the most important health concerns for women. This book provides a comprehensive overview of the diagnostic and therapeutic aspects of the management of early-stage breast cancer, including essential information on basic topics like pathology, and radiology, as well as the latest developments. Further, it discusses all aspects of surgical care, chemotherapy and radiation therapy, together with the controversies and current management guidelines. Helping readers acquire a deep, holistic understanding of the topic, the book is a valuable resource for practitioners and postgraduate students in the field of gynecologic oncology. Moreover, it is a useful aid to decision-making in day-to-day practice for oncologists, residents, fellows and experienced practitioners.
Download or read book Her-2 written by Robert Bazell and published by Random House. This book was released on 2011-04-27 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Two years after she underwent a mastectomy and chemotherapy, Barbara Bradfield's aggressive breast cancer had recurred and spread to her lungs. The outlook was grim. Then she took part in Genentech's clinical trials for a new drug. Five years later she remains cancer-free. Her-2 is the biography of Herceptin, the drug that provoked dramatic responses in Barbara Bradfield and other women in the trials and that offers promise for hundreds of thousands of breast cancer patients. Unlike chemotherapy or radiation, Herceptin has no disabling side effects. It works by inactivating Her-2/neu--a protein that makes cancer cells grow especially quickly-- produced by a gene found in 25 to 30 percent of all breast tumors. Herceptin caused some patients' cancers to disappear completely; in others, it slowed the progression of the disease and gave the women months or years they wouldn't otherwise have had. Herceptin is the first treatment targeted at a gene defect that gives rise to cancer. It marks the beginning of a new era of treatment for all kinds of cancers. Robert Bazell presents a riveting account of how Herceptin was born. Her-2 is a story of dramatic discoveries and strong personalities, showing the combination of scientific investigation, money, politics, ego, corporate decisions, patient activism, and luck involved in moving this groundbreaking drug from the lab to a patient's bedside. Bazell's deft portraits introduce us to the remarkable people instrumental in Herceptin's history, including Dr. Dennis Slamon, the driven UCLA oncologist who played the primary role in developing the treatment; Lily Tartikoff, wife of television executive Brandon Tartikoff, who tapped into Hollywood money and glamour to help fund Slamon's research; and Marti Nelson, who inspired the activists who lobbied for a "compassionate use" program that would allow women outside the clinical trials to have access to the limited supplies of Herceptin prior to FDA approval of the drug. And throughout there are the stories of the heroic women with advanced breast cancer who volunteered for the trials, risking what time they had left on an unproven treatment. Meticulously researched, written with clarity and compassion, Her-2 is masterly reporting on cutting-edge science.
Book Synopsis Developing Technologies for Early Detection of Breast Cancer by : National Research Council
Download or read book Developing Technologies for Early Detection of Breast Cancer written by National Research Council and published by National Academies Press. This book was released on 2000-07-06 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: In November 1999, the Institute of Medicine, in consultation with the Commission on Life Sciences, the Commission on Physical Sciences, Mathematics, and Applications, and the Board on Science, Technology and Economic Policy launched a one year study on technologies for early detection of breast cancer. The committee was asked to examine technologies under development for early breast cancer detection, and to scrutinize the process of medical technology development, adoption, and dissemination. The committee is gathering information on these topics for its report in a number of ways, including two public workshops that bring in outside expertise. The first workshop on "Developing Technologies for Early Breast Cancer Detection" was held in Washington DC in February 2000. The content of the presentations at the workshop is summarized here. A second workshop, which will focus on the process of technology development and adoption, will be held in Washington, DC on June 19-20. A formal report on these topics, including conclusions and recommendations, will be prepared by the committee upon completion of the one-year study.
Book Synopsis Accelerated Partial Breast Irradiation by : David E. Wazer
Download or read book Accelerated Partial Breast Irradiation written by David E. Wazer and published by Springer Science & Business Media. This book was released on 2009-08-11 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated partial breast irradiation (APBI) is being rapidly introduced into the clinical management of early breast cancer. APBI, in fact, encompasses a number of different techniques and approaches that include brachytherapy, intraoperative, and external beam techniques. There is currently no single source that describes these techniques and their clinical implementation. This text is a concise handbook designed to assist the clinician in the implementation of APBI. This includes a review of the principles that underlie APBI, a practical and detailed description of each technique for APBI, a review of current clinical results of APBI, and a review of the incidence and management of treatment related complications.
Download or read book Cancer and Aging written by M. Extermann and published by Karger Medical and Scientific Publishers. This book was released on 2013-01-18 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer is clearly an age-related disease. Recent research in both aging and cancer has demonstrated the complex interaction between the two phenomena. This affects a wide spectrum of research and practice, anywhere from basic research to health care organization. Core examples of these close associations are addressed in this book. Starting with basic research, the first chapters cover cancer development, mTOR inhibition, senescent cells altering the tumor microenvironment, and immune senescence affecting cancer vaccine response. Taking into account the multidisciplinarity of geriatric oncology, several chapters focus on geriatric and oncologic aspects in patient assessment, treatment options, nursing and exercise programs. The book is rounded off by a discussion on the impact of the metabolic syndrome illustrating the interactions between comorbidity and cancer and a chapter on frailty.This book provides the reader with insights that will hopefully foster his or her reflection in their own research and practice to further the development of this most exciting field. Given the aging of the population worldwide and the high prevalence of cancer, it is essential reading not only for oncologists and geriatricians but for all health practitioners.
Book Synopsis A Series of Catastrophes and Miracles by : Mary Elizabeth Williams
Download or read book A Series of Catastrophes and Miracles written by Mary Elizabeth Williams and published by Disney Electronic Content. This book was released on 2016-04-26 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: A wry, witty account of what it is like to face death—and be restored to life. After being diagnosed in her early 40s with metastatic melanoma—a "rapidly fatal" form of cancer—journalist and mother of two Mary Elizabeth Williams finds herself in a race against the clock. She takes a once-in-a-lifetime chance and joins a clinical trial for immunotherapy, a revolutionary drug regimen that trains the body to vanquish malignant cells. Astonishingly, her cancer disappears entirely in just a few weeks. But at the same time, her best friend embarks on a cancer journey of her own—with very different results. Williams's experiences as a patient and a medical test subject reveal with stark honesty what it takes to weather disease, the extraordinary new developments that are rewriting the rules of science—and the healing power of human connection.
Book Synopsis HER2-Positive Breast Cancer by : Sara Hurvitz
Download or read book HER2-Positive Breast Cancer written by Sara Hurvitz and published by Elsevier Health Sciences. This book was released on 2018-07-26 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get a quick, expert overview of clinically-focused topics and guidelines that are relevant to testing for HER2, which contributes to approximately 25% of breast cancers today. This concise resource by Drs. Sara Hurvitz, and Kelly McCann consolidates today's available information on this growing topic into one convenient resource, making it an ideal, easy-to-digest reference for practicing and trainee oncologists. - Covers the diagnosis, treatments and targeted therapies, and management of breast cancers that are HER2-positive. - Contains sections on background and testing, advanced disease, therapeutics, and toxicity considerations. - Includes a timely section on innovative future therapies.
Book Synopsis Statistical Methods in Drug Combination Studies by : Wei Zhao
Download or read book Statistical Methods in Drug Combination Studies written by Wei Zhao and published by CRC Press. This book was released on 2014-12-19 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve
