Author: Thomas J. FitzGerald
Publisher:
ISBN:
Category : Electronic books
Languages : en
Pages : 0
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Book Description
Clinical trials in radiation oncology have improved our translational science and patient care. All patients referred to departments of radiation oncology can be invited to participate in a clinical trial with multiple venues. Study endpoints can include intradepartmental endpoints to improve workflow and patient access as well as interdepartmental clinical translational trials that include the National Clinical Trials Network (NCTN) and industry. The quality of the trial is important to trial outcome and influences interpretation of the results of the study and how the results can be applied to patient care moving forward. Clinical trials in radiation oncology to date have accomplished much, however many important questions remain as patient care matures and systemic therapies become more sophisticated and associated with specific biomarkers and cellular expression products. In this chapter we review the history of clinical trials in radiation oncology and review the current status of the structure of quality assurance in clinical trials. We will review unanswered questions and areas to study in each disease area and how to design strategy for trials to address modern unmet needs in our discipline.
Author: Kerstin A. Kessel
Publisher: Frontiers Media SA
ISBN: 288945438X
Category : Cancer
Languages : en
Pages : 109
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Book Description
In radiation oncology as in many other specialties clinical trials are essential to investigate new therapy approaches. Usually, preparation for a prospective clinical trial is extremely time consuming until ethics approval is obtained. To test a new treatment usually many years pass before it can be implemented in the routine care. During that time, already new interventions emerge, new drugs appear on the market, technical & physical innovations are being implemented, novel biology driven concepts are translated into clinical approaches while we are still investigating the ones from years ago. Another problem is associated with molecular diagnostics and the growing amount of tumor specific biomarkers which allows for a better stratification of patient subgroups. On the other side, this may result in a much longer time for patient recruiting and consequently in larger multicenter trials. Moreover, all of the relevant data must be readily available for treatment decision making, treatment as well as follow-up, and ultimately for trial evaluation. This challenges even more for agreed standards in data acquisition, quality and management. How could we change the way currently clinical trials are performed in a way they are safe and ethically justifiable and speed up the initiation process, so we can provide new and better treatments faster for our patients? Further, while we rely on various quantitative information handling distributed, large heterogeneous amounts of data efficiently is very important. Thus data management becomes a strong focus. A good infrastructure helps to plan, tailor and conduct clinical trials in a way they are easy and quickly analyzable. In this research topic we want to discuss new ideas for intelligent trial designs and concepts for data management.
Author: Jake Van Dyk
Publisher: Medical Physics Publishing Corporation
ISBN:
Category : Medical
Languages : es
Pages : 1106
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Book Description
Details technology associated with radiation oncology, emphasizing design of all equipment allied with radiation treatment. Describes procedures required to implement equipment in clinical service, covering needs assessment, purchase, acceptance, and commissioning, and explains quality assurance issues. Also addresses less common and evolving technologies. For medical physicists and radiation oncologists, as well as radiation therapists, dosimetrists, and engineering technologists. Includes bandw medical images and photos of equipment. Paper edition (unseen), $145.95. Annotation copyrighted by Book News, Inc., Portland, OR
Author: Allan Hackshaw
Publisher: Karger Medical and Scientific Publishers
ISBN: 1912776731
Category : Medical
Languages : en
Pages : 120
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Book Description
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. Contents: • Fundamental features of clinical trials • Phase I trials • Phase II trials • Phase III trials • Trials of non-drug interventions • Setting up and conducting trials • Publishing trial results, changing clinical practice, and supporting evidence
Author: Peter Keating
Publisher: University of Chicago Press
ISBN: 022614304X
Category : Medical
Languages : en
Pages : 475
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Book Description
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.
Author: Stephanie Green
Publisher: CRC Press
ISBN: 1439814481
Category : Mathematics
Languages : en
Pages : 266
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Book Description
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.
Author: William Small, Jr.
Publisher: John Wiley & Sons
ISBN: 1119341213
Category : Medical
Languages : en
Pages : 944
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Book Description
This fully updated and enhanced third edition offers a highly practical, application-based review of the biological basis of radiation oncology and the clinical efficacy of radiation therapy. Revised edition of the classic reference in radiation oncology from Dr. C.C. Wang, whose practical approach to clinical application was legendary Includes the latest developments in the field: intensity modulated radiation therapy (IMRT), image guided radiation therapy, and particle beam therapy Includes two brand new chapters Palliative Radiotherapy, and Statistics in Radiation Oncology Features a vibrant and extremely comprehensive head and neck section Provides immediately applicable treatment algorithms for each tumor
Author: Wan Tang
Publisher: Springer Science & Business Media
ISBN: 1461443229
Category : Medical
Languages : en
Pages : 256
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Book Description
This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a different purpose: it provides a quick introduction to each topic for self-learning, particularly for those who have not done any formal coursework on a given topic but must learn it due to its relevance to their multidisciplinary research. In addition, the chapters on these classic topics will reflect issues particularly relevant to modern clinical trials such as longitudinal designs and new methods for analyzing data from such study designs. The coverage of these topics provides a quick introduction to these important statistical issues and methods for addressing them. As with the classic topics, this part of the volume on modern topics will enable researchers to grasp the statistical methods for addressing these emerging issues underlying modern clinical trials and to apply them to their research studies.
Author: Matthew C. Ward, MD
Publisher: Springer Publishing Company
ISBN: 0826168558
Category : Medical
Languages : en
Pages : 671
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Book Description
Essentials of Clinical Radiation Oncology is a comprehensive, user-friendly clinical review that summarizes up-to-date cancer care in an easy-to-read format. Each chapter is structured for straightforward navigability and information retention beginning with a “quick-hit” summary that contains an overview of each disease, its natural history, and general treatment options. Following each "quick-hit" are high-yield summaries covering epidemiology, risk factors, anatomy, pathology, genetics, screening, clinical presentation, workup, prognostic factors, staging, treatment paradigms, and medical management for each malignancy. Each treatment paradigm section describes the current standard of care for radiation therapy including indications, dose constraints, and side effects. Chapters conclude with an evidence-based question and answer section which summarizes practice-changing data to answer key information associated with radiation treatment outcomes. Flow diagrams and tables consolidate information throughout the book that all radiation oncologists and related practitioners will find extremely useful when approaching treatment planning and clinical care. Essentials of Clinical Radiation Oncology has been designed to replicate a "house manual" created and used by residents in training and is a "one-stop" resource for practicing radiation oncologists, related practitioners, and radiation oncology residents entering the field. Key Features: Offers digestible information as a learning guide for general practice Examines essential clinical questions which are answered with evidence-based data from important clinical studies Places clinical trials and data into historical context and points out relevance in current practice Provides quick reference tables on treatment options and patient selection, workup, and prognostic factors by disease site
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309306698
Category : Medical
Languages : en
Pages : 125
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Book Description
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.
