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Real World Data And Real World Evidence In Lung Cancer
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Book Synopsis Real-World Data and Real-World Evidence in Lung Cancer by : Valerio Gristina
Download or read book Real-World Data and Real-World Evidence in Lung Cancer written by Valerio Gristina and published by Frontiers Media SA. This book was released on 2024-06-14 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lung cancer is still one of the most common malignancies with a high global mortality rate with over 2 million cases confirmed by the World Health Organization in 2018. Although there has been progress in diagnosing and treating lung cancer, patients still have poor prognosis with a 5-year survival rate typically from 4-17% which is dependent on the stage of the cancer and regional differences. The majority of lung cancer patients are at the advanced stages of the disease at the time of their diagnosis and therefore, have less chances of early treatment that could have improved their survival rate. Therefore, early detection of lung cancer remains imperative to improve the prognosis.
Book Synopsis Post-Authorization Safety Studies of Medicinal Products by : Ayad K. Ali
Download or read book Post-Authorization Safety Studies of Medicinal Products written by Ayad K. Ali and published by Academic Press. This book was released on 2018-06-27 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues
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)
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.
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.
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)
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.
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 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.
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)
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)
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)
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.
Book Synopsis The Future of Drug Safety by : Institute of Medicine
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Book Synopsis Real-World Evidence in Lung Cancer by : Alfredo Addeo
Download or read book Real-World Evidence in Lung Cancer written by Alfredo Addeo and published by Frontiers Media SA. This book was released on 2021-09-24 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
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.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 pages Book Rating :4.5/5 (876 download)
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 396 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.
Book Synopsis Making Data Talk by : David E. Nelson (M.D.)
Download or read book Making Data Talk written by David E. Nelson (M.D.) and published by Oxford University Press, USA. This book was released on 2009 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors summarize and synthesize research on the selection and presentation of data pertinent to public health and provide practical suggestions, based on this research summary and synthesis, on how scientists and other public health practitioners can better communicate data to the public, policy makers and the press.
Book Synopsis From clinical trials to real-world data sciences: Evidence-based medicine for value in health by : Kevin Lu
Download or read book From clinical trials to real-world data sciences: Evidence-based medicine for value in health written by Kevin Lu and published by Frontiers Media SA. This book was released on 2023-03-16 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Ending Medical Reversal by : Vinayak K. Prasad
Download or read book Ending Medical Reversal written by Vinayak K. Prasad and published by JHU Press. This book was released on 2015-11 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medications such as Vioxx and procedures such as vertebroplasty for back pain are among the medical "advances" that turned out to be dangerous or useless. What Dr. Vinayak K. Prasad and Dr. Adam S. Cifu call medical reversal happens when doctors start using a medication, procedure, or diagnostic tool without a robust evidence base—and then stop using it when it is found not to help, or even to harm, patients. In Ending Medical Reversal, Drs. Prasad and Cifu narrate fascinating stories from every corner of medicine to explore why medical reversals occur, how they are harmful, and what can be done to avoid them. They explore the difference between medical innovations that improve care and those that only appear to be promising. They also outline a comprehensive plan to reform medical education, research funding and protocols, and the process for approving new drugs that will ensure that more of what gets done in doctors' offices and hospitals is truly effective. "Every doctor should read this book."—JAMA Internal Medicine "[A]n excellent and realistic discussion of some of the horror stories that occur in medical practice . . . Highly recommended."—Choice "Ending Medical Reversal goes far in teaching medical students and practicing physicians alike how to learn on our own."—The Lancet "This has to be on the reading list for medical and nursing students."—Nursing Times "Ending Medical Reversal presents persuasive evidence that many current standard-of-care treatments are probably ineffective or harmful, thoroughly explains how such treatments came to be accepted, and proposes a number of ways to address the general problem (only some of which involve avaricious companies and mercenary physicians) and minimize its impact on a specific patient."—Journal of Clinical Research Best Practices "Dr. Prasad and Dr. Cifu offer a five-step plan, including pointers for determining if a given treatment is really able to do what you want it to do, and advice on finding a like-minded doctor who won't object to a certain amount of back-seat driving."—The New York Times "When I describe Ending Medical Reversal as revolutionary, I don't use the term lightly. Go out and read it—right now."—Common Sense Family Doctor "Should be considered for undergraduate reading lists. Keep a copy in the pharmacy or your briefcase as a great icebreaker or discussion point with other local healthcare professionals."—The Pharmaceutical Journal
