Real World Data And Real World Evidence In Hematologic Malignancies

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Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Examining the Impact of Real-World Evidence on Medical Product Development

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030948832X
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Examining the Impact of Real-World Evidence on Medical Product Development by : National Academies of Sciences, Engineering, and Medicine

Download or read book Examining the Impact of Real-World Evidence on Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Real-World Data and Real-World Evidence in Hematologic Malignancies

Author : Michele Malagola
Publisher : Frontiers Media SA
ISBN 13 : 2832528058
Total Pages : 196 pages
Book Rating : 4.8/5 (325 download)

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Book Synopsis Real-World Data and Real-World Evidence in Hematologic Malignancies by : Michele Malagola

Download or read book Real-World Data and Real-World Evidence in Hematologic Malignancies written by Michele Malagola and published by Frontiers Media SA. This book was released on 2023-07-10 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Research Informatics

Author : Rachel Richesson
Publisher : Springer Science & Business Media
ISBN 13 : 1848824475
Total Pages : 415 pages
Book Rating : 4.8/5 (488 download)

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Book Synopsis Clinical Research Informatics by : Rachel Richesson

Download or read book Clinical Research Informatics written by Rachel Richesson and published by Springer Science & Business Media. This book was released on 2012-02-15 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

Clinical Radiation Oncology

Author : Leonard L. Gunderson, MD, MS, FASTRO
Publisher : Elsevier Health Sciences
ISBN 13 : 0323240984
Total Pages : 2253 pages
Book Rating : 4.3/5 (232 download)

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Book Synopsis Clinical Radiation Oncology by : Leonard L. Gunderson, MD, MS, FASTRO

Download or read book Clinical Radiation Oncology written by Leonard L. Gunderson, MD, MS, FASTRO and published by Elsevier Health Sciences. This book was released on 2015-08-26 with total page 2253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perfect for radiation oncology physicians and residents needing a multidisciplinary, treatment-focused resource, this updated edition continues to provide the latest knowledge in this consistently growing field. Not only will you broaden your understanding of the basic biology of disease processes, you'll also access updated treatment algorithms, information on techniques, and state-of-the-art modalities. The consistent and concise format provides just the right amount of information, making Clinical Radiation Oncology a welcome resource for use by the entire radiation oncology team. Content is templated and divided into three sections -- Scientific Foundations of Radiation Oncology, Techniques and Modalities, and Disease Sites - for quick access to information. Disease Sites chapters summarize the most important issues on the opening page and include a full-color format, liberal use of tables and figures, a closing section with a discussion of controversies and problems, and a treatment algorithm that reflects the treatment approach of the authors. Chapters have been edited for scientific accuracy, organization, format, and adequacy of outcome data (such as disease control, survival, and treatment tolerance). Allows you to examine the therapeutic management of specific disease sites based on single-modality and combined-modality approaches. Features an emphasis on providing workup and treatment algorithms for each major disease process, as well as the coverage of molecular biology and its relevance to individual diseases. Two new chapters provide an increased emphasis on stereotactic radiosurgery (SRS) and stereotactic body irradiation (SBRT). New Associate Editor, Dr. Andrea Ng, offers her unique perspectives to the Lymphoma and Hematologic Malignancies section. Key Points are summarized at the beginning of each disease-site chapter, mirroring the template headings and highlighting essential information and outcomes. Treatment algorithms and techniques, together with discussions of controversies and problems, reflect the treatment approaches employed by the authors. Disease Site Overviews allow each section editor to give a unique perspective on important issues, while online updates to Disease Site chapters ensure your knowledge is current. Disease Site chapters feature updated information on disease management and outcomes. Four videos accessible on Expert Consult include Intraoperative Irradiation, Prostate Brachytherapy, Penile Brachytherapy, and Ocular Melanoma. Thirty all-new anatomy drawings increase your visual understanding. Expert Consult eBook version included with purchase. This enhanced eBook experience allows you to search all of the text, figures, and references from the book on a variety of devices.

Real-World Evidence in Drug Development and Evaluation

Author : Harry Yang
Publisher : CRC Press
ISBN 13 : 0429676824
Total Pages : 191 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Real-World Evidence in Drug Development and Evaluation by : Harry Yang

Download or read book Real-World Evidence in Drug Development and Evaluation written by Harry Yang and published by CRC Press. This book was released on 2021-01-11 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

Rare Disease Drug Development

Author : Raymond A. Huml
Publisher : Springer Nature
ISBN 13 : 3030786056
Total Pages : 418 pages
Book Rating : 4.0/5 (37 download)

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Book Synopsis Rare Disease Drug Development by : Raymond A. Huml

Download or read book Rare Disease Drug Development written by Raymond A. Huml and published by Springer Nature. This book was released on 2021-11-08 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.

Case-Control Studies

Author : Ruth H. Keogh
Publisher : Cambridge University Press
ISBN 13 : 1139867466
Total Pages : 297 pages
Book Rating : 4.1/5 (398 download)

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Book Synopsis Case-Control Studies by : Ruth H. Keogh

Download or read book Case-Control Studies written by Ruth H. Keogh and published by Cambridge University Press. This book was released on 2014-03-06 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: The case-control approach is a powerful method for investigating factors that may explain a particular event. It is extensively used in epidemiology to study disease incidence, one of the best-known examples being Bradford Hill and Doll's investigation of the possible connection between cigarette smoking and lung cancer. More recently, case-control studies have been increasingly used in other fields, including sociology and econometrics. With a particular focus on statistical analysis, this book is ideal for applied and theoretical statisticians wanting an up-to-date introduction to the field. It covers the fundamentals of case-control study design and analysis as well as more recent developments, including two-stage studies, case-only studies and methods for case-control sampling in time. The latter have important applications in large prospective cohorts which require case-control sampling designs to make efficient use of resources. More theoretical background is provided in an appendix for those new to the field.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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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.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 236 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

The Drug Development Paradigm in Oncology

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)

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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.

The Economics of Cancer Care

Author : Nicholas Bosanquet
Publisher : Cambridge University Press
ISBN 13 : 1139450719
Total Pages : 175 pages
Book Rating : 4.1/5 (394 download)

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Book Synopsis The Economics of Cancer Care by : Nicholas Bosanquet

Download or read book The Economics of Cancer Care written by Nicholas Bosanquet and published by Cambridge University Press. This book was released on 2006-03-23 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 2006 book examines the interaction of economics and the delivery of cancer care in the global context. It analyses the causes of tension between those paying for care, those providing the care and those marketing drugs and devices. The concept and requirement for rationing is examined in different economic environments. As cancer increases in incidence and prevalence, the economics of providing care becomes a more important subject than ever before. Written by a leading health economist and oncologist, this was the first comprehensive book on the economics of cancer care continues to be of interest to health professionals and policy makers alike.

Real-world Evidence in Onco-Hematological Patients

Author : Claudia Vener
Publisher : Frontiers Media SA
ISBN 13 : 2832508340
Total Pages : 146 pages
Book Rating : 4.8/5 (325 download)

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Book Synopsis Real-world Evidence in Onco-Hematological Patients by : Claudia Vener

Download or read book Real-world Evidence in Onco-Hematological Patients written by Claudia Vener and published by Frontiers Media SA. This book was released on 2022-12-02 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Real-World Evidence Generation and Evaluation of Therapeutics

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309455650
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Real-World Evidence Generation and Evaluation of Therapeutics by : National Academies of Sciences, Engineering, and Medicine

Download or read book Real-World Evidence Generation and Evaluation of Therapeutics written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-05 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.

The Learning Healthcare System

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133939
Total Pages : 374 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Learning Healthcare System by : Institute of Medicine

Download or read book The Learning Healthcare System written by Institute of Medicine and published by National Academies Press. This book was released on 2007-06-01 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.

Evidence-Based Medicine and the Changing Nature of Health Care

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309113695
Total Pages : 202 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Evidence-Based Medicine and the Changing Nature of Health Care by : Institute of Medicine

Download or read book Evidence-Based Medicine and the Changing Nature of Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2008-09-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

Thoracic Malignancies

Author : Steven E. Schild, MD
Publisher : Demos Medical Publishing
ISBN 13 : 1935281801
Total Pages : 260 pages
Book Rating : 4.9/5 (352 download)

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Book Synopsis Thoracic Malignancies by : Steven E. Schild, MD

Download or read book Thoracic Malignancies written by Steven E. Schild, MD and published by Demos Medical Publishing. This book was released on 2010-03-08 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoracic Malignancies: Thoracic Malignancies is the first title in Radiation Medicine Rounds. These tumors take more lives than any others and they are among the most preventable of tumors. Thus it is crucial for the practitioner to be up-to-date on the latest insights regarding their management. Thoracic Malignancies addresses the multi-disciplinary nature of the care of these tumors. There is representation from radiation oncology, medical oncology, and surgery ensuring a well-rounded summarization of current practice. Included are chapters on lung cancer, esophageal cancer, and thymomas providing coverage of the vast majority of thoracic tumors. The multi-disciplinary nature of the articles provides readers with an up-to-date summary and a well-rounded review regarding these tumors and their care. Expert authors provide reviews and assessments of the most recent data and its implications for current clinical practice, along with insights into emerging new trends of importance for the near future. About the Series Radiation Medicine Rounds is an invited review publication providing a thorough analysis of new scientific, technologic, and clinical advances in all areas of radiation medicine. There is an emphasis throughout on multidisciplinary approaches to the specialty, as well as on quality and outcomes analysis. Published three times a year Radiation Medicine Rounds provides authoritative, thorough assessments of a wide range of Ïhot topicsÓ and emerging new data for the entire specialty of radiation medicine. Features of Radiation Medicine Rounds include: Editorial board of nationally recognized experts across the spectrum of radiation medicine In-depth, up-to-date expert reviews and analysis of major new developments in all areas of Radiation Medicine Issues edited by an authority in specific subject area Focuses on major topics in Radiation Medicine with in-depth articles covering advances in radiation science radiation medicine technology, radiation medicine practice, and assessment of recent quality and outcomes studies Emphasizes multidisciplinary approaches to research and practice