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Author: Rachel Richesson
Publisher: Springer Science & Business Media
ISBN: 1848824475
Category : Medical
Languages : en
Pages : 415
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Book Description
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: Rachel Richesson
Publisher: Springer Science & Business Media
ISBN: 1848824475
Category : Medical
Languages : en
Pages : 415
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Book Description
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: 030948832X
Category : Medical
Languages : en
Pages : 231
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Book Description
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.
Author: Michele Malagola
Publisher: Frontiers Media SA
ISBN: 2832528058
Category : Medical
Languages : en
Pages : 196
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Book Description
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
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.
Author: Leonard L. Gunderson, MD, MS, FASTRO
Publisher: Elsevier Health Sciences
ISBN: 0323240984
Category : Medical
Languages : en
Pages : 2253
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Book Description
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.
Author: Ruth H. Keogh
Publisher: Cambridge University Press
ISBN: 1139867466
Category : Mathematics
Languages : en
Pages : 297
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Book Description
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: Harry Yang
Publisher: CRC Press
ISBN: 0429676824
Category : Mathematics
Languages : en
Pages : 191
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Book Description
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
Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 236
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Book Description
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: Raymond A. Huml
Publisher: Springer Nature
ISBN: 3030786056
Category : Medical
Languages : en
Pages : 418
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309457971
Category : Medical
Languages : en
Pages : 145
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Book Description
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.
