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Author: Wolfgang Link Publisher: Springer Nature ISBN: 3030187225 Category : Medical Languages : en Pages : 156
Book Description
This book explains how current medicines against cancer work and how we find new ones. It provides an easy-to-understand overview of current options to treat patients with cancer, which includes Surgery, Radiation therapy, Chemotherapy, Targeted therapy and Immunotherapy. The efficiency of all these treatments is limited by the capacity of cancer cells to escape therapy. This book explains the mechanisms of anti-cancer drug resistance and strategies to overcome it. The discovery and development process of a new drug is detailed beginning with the identification and validation of a therapeutic target, the identification of an inhibitor of the target and its subsequent preclinical and clinical development until its approval by regulatory authorities. Particular emphasis has been given to specific aspects of the development process including lead generation and optimization, pharmacokinetics, ADME analysis, pharmacodynamics, toxicity and efficacy assessment, investigational new drug (IND) and new drug application (NDA) and the design of clinical trial and their phases. The book covers many aspects of modern personalized oncology and discusses economic aspects of our current system of developing new medicines and its impact on our societies and on future drug research. The author of this book, Dr. Link counts with more than 20 years of experience in biomedical research reflected in numerous publications, patents and key note and plenary presentations at international conferences. Interested readers, students and teachers should read this book as it provides a unique way to learn/teach about basic concepts in oncology and anti-cancer drug research.
Author: Wolfgang Link Publisher: Springer Nature ISBN: 3030187225 Category : Medical Languages : en Pages : 156
Book Description
This book explains how current medicines against cancer work and how we find new ones. It provides an easy-to-understand overview of current options to treat patients with cancer, which includes Surgery, Radiation therapy, Chemotherapy, Targeted therapy and Immunotherapy. The efficiency of all these treatments is limited by the capacity of cancer cells to escape therapy. This book explains the mechanisms of anti-cancer drug resistance and strategies to overcome it. The discovery and development process of a new drug is detailed beginning with the identification and validation of a therapeutic target, the identification of an inhibitor of the target and its subsequent preclinical and clinical development until its approval by regulatory authorities. Particular emphasis has been given to specific aspects of the development process including lead generation and optimization, pharmacokinetics, ADME analysis, pharmacodynamics, toxicity and efficacy assessment, investigational new drug (IND) and new drug application (NDA) and the design of clinical trial and their phases. The book covers many aspects of modern personalized oncology and discusses economic aspects of our current system of developing new medicines and its impact on our societies and on future drug research. The author of this book, Dr. Link counts with more than 20 years of experience in biomedical research reflected in numerous publications, patents and key note and plenary presentations at international conferences. Interested readers, students and teachers should read this book as it provides a unique way to learn/teach about basic concepts in oncology and anti-cancer drug research.
Author: John I. Gallin Publisher: Elsevier ISBN: 0080489567 Category : Science Languages : en Pages : 447
Book Description
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
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.
Author: Susan Halabi, PhD Publisher: Demos Medical Publishing ISBN: 1935281763 Category : Medical Languages : en Pages : 396
Book Description
Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
Author: Robert C. Bast, Jr. Publisher: John Wiley & Sons ISBN: 111900084X Category : Medical Languages : en Pages : 2004
Book Description
Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates
Author: Fred Bunz Publisher: Springer ISBN: 9401774846 Category : Medical Languages : en Pages : 354
Book Description
This is the second edition of a widely used textbook that consolidates the basic concepts of the cancer gene theory and provides a framework for understanding the genetic basis of cancer. Particular attention is devoted to the origins of the mutations that cause cancer, and the application of evolutionary theory to explain how the cell clones that harbor cancer genes tend to expand. Focused on the altered genes and pathways that cause the growth of the most common tumors, Principles of Cancer Genetics is aimed at advanced undergraduates who have completed introductory coursework in genetics, biology and biochemistry, medical students and medical house staff. For students with a general interest in cancer, this book provides a highly accessible and readable overview. For more advanced students contemplating future study in the field of oncology and cancer research, this concise book will be useful as a primer.
Author: Howard L. Kaufman Publisher: Springer Science & Business Media ISBN: 1402060874 Category : Medical Languages : en Pages : 502
Book Description
This book brings together the world’s leading authorities on tumor immunology. This book describes the basic immunology principles that form the foundation of understanding how the immune system recognizes and rejects tumor cells. The role of the innate and adaptive immune responses is discussed and the implications of these responses for the design of clinical strategies to combat cancer are illustrated.
Author: Loren K. Mell, MD Publisher: Springer Publishing Company ISBN: 1617052396 Category : Medical Languages : en Pages : 608
Book Description
Principles of Clinical Cancer Research provides comprehensive coverage of the fundamentals of clinical cancer research, including the full spectrum of methodologies used in the field. For those involved in research or considering research careers, this book offers a mix of practical advice and analytical tools for effective training in theoretical principles as well as specific, usable teaching examples. The clinical oncologist or trainee will find a high-yield, practical guide to the interpretation of the oncology literature and the application of data to real-world settings. Valuable for both researchers and clinicians who wish to sharpen their skills, this book contains all of the cornerstones and explanations needed to produce and recognize quality clinical science in oncology. Written from the physician-scientist’s perspective, the book lays a strong foundation in preclinical sciences that is highly relevant to careers in translational oncology research along with coverage of population and outcomes research and clinical trials. It brings together fundamental principles in oncology with the statistical concepts one needs to know to design and interpret studies successfully. With each chapter including perspectives of both clinicians and scientists or biostatisticians, Principles of Clinical Cancer Research provides balanced, instructive, and high-quality topic overviews and applications that are accessible and thorough for anyone in the field. KEY FEATURES: Gives real-world examples and rationales behind which research methods to use when and why Includes numerous tables featuring key statistical methods and programming commands used in everyday clinical research Contains illustrative practical examples and figures in each chapter to help the reader master concepts Provides tips and pointers for structuring a career, avoiding pitfalls, and achieving success in the field of clinical cancer research Access to fully downloadable eBook
Author: Steven Piantadosi Publisher: Springer Nature ISBN: 3319526367 Category : Medical Languages : en Pages : 2573
Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Author: Paul H. Sugarbaker Publisher: Springer Science & Business Media ISBN: 1461312477 Category : Medical Languages : en Pages : 434
Book Description
Paul Sugarbaker and his colleagues have persevered in the study and treat ment of peritoneal carcinomatosis. The peritoneal cavity has many unique and incompletely appreciated properties. These properties, coupled with the biologic behavior of many cancers, results in the seeding and growth of these cancers on the peritoneum. Many of these cancers remain localized to the peritoneum only, never metastasizing to other sites. One possible reason for this may be the obstruction of the afferent lymphatics on the undersurface of the diaphragm. The mucopolysaccharides produced by many of these neoplasma are probably viscous enough to obstruct these lymphatics, leading to the syndrome of pseudomyxoma peritonei. Many of the neoplasms taking residence on the peritoneum have extremely long cell-cycle times and are resistant to radiotherapy and many chemotherapeutic agents. How ever, much can be done for these patients - resection of primary cancers, omentectomies to reduce ascites formation, management of recurrent ascites, management of intestinal obstruction, nutritional care, and, hopefully, intraperitoneal chemotherapy. We have reviewed many of these problems in the past [1-7]. Dr. Sugarbaker and his colleagues have organized the current state of knowledge and technology for continuing use. The book provides a basis for thoughtful, prospective research planning. John S. Spratt, M. D. , F. A. C. S. Professor of Surgery The James Graham Brown Cancer Center University of Louisville Louisville, Kentucky References 1. Long RTL, Spratt JS, Dowling E.
Author: Wolfgang Link
Author: Wolfgang Link
Author: John I. Gallin
Author: Institute of Medicine
Author: Susan Halabi, PhD
Author: Robert C. Bast, Jr.
Author: Fred Bunz
Author: Howard L. Kaufman
Author: Loren K. Mell, MD
Author: Steven Piantadosi
Author: Paul H. Sugarbaker