Download or read book Sample Size Tables for Clinical Studies written by David Machin and published by John Wiley & Sons. This book was released on 2011-08-26 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides statisticians and researchers with the statistical tools - equations, formulae and numerical tables - to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analysing clinical studies is a very complicated business and this book provides indispensible factual information. Please go to http://booksupport.wiley.com and enter 9781405146500 to easily download the supporting materials.
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Download or read book Laboratory and Clinical Studies written by New York (N.Y.). Memorial Hospital for the Treatment of Cancer and Allied Diseases and published by . This book was released on 1905 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Download or read book Good Clinical Laboratory and Manufacturing Practices written by Philip Carson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-08-19 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Download or read book Design and Planning of Research and Clinical Laboratory Facilities written by Leonard Mayer and published by John Wiley & Sons. This book was released on 1995-02-20 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: DESIGN and PLANNING of Research and Clinical LABORATORYFACILITIES In this primer/professional reference, Leonard Mayer demystifiesone of the most complex architectural specialties. An architectwith more than thirty-three years' experience as a master plannerand programmer of laboratories and clinical facilities, Mr. Mayeroffers a comprehensive overview of the fundamental issues relatedto laboratory planning and design. He also provides designers witha clear and rational framework through which to approach thishighly challenging and rewarding design specialty. A superblearning tool for students and professionals just getting startedin lab design and a valuable one-volume reference for theexperienced professional, Design and Planning of Research andClinical Laboratory Facilities features: * Step-by-step guidance through the complex maze of codes,specifications, standards, and official guidelines, relating to theplanning, design, and construction processes * New and updated design criteria based on the most recent laws andregulations * Master plans, facility programs, functional programs andrequirements programs for a wide variety of scientific and medicaldisciplines and support facilities * Comprehensive lists of relevant codes, regulations, standards,guidelines, and important architectural, structural, mechanical,electrical, and plumbing criteria Research and clinical laboratory facilities are, perhaps, the mostcomplex structures to plan and design. Intimidated by a vast andseemingly impenetrable body of codes, regulations, and designcriteria pertaining to lab design and construction, manyarchitects, unfortunately, choose to avoid what can be one of themost profitable and professionally rewarding areas ofspecialization. Written by an architect with more than thirty-three years ofexperience as a master planner and programmer of laboratories andclinical facilities, this book demystifies the process oflaboratory planning and design. It provides a comprehensiveoverview of the fundamental issues related to laboratory design andoffers readers detailed, step-by-step guidance through the complexmaze of design specifications and codes, standards, and officialguidelines that must be addressed during the programming, planning,design, and construction process. Focusing mainly on laboratory programming, planning, and designcriteria for "wet" laboratory environments, Leonard Mayer providesexamples from numerous master plans, facility programs, functionalprograms and requirements programs applicable to a wide variety ofscientific and medical disciplines, and related facilities. Relatedfunctions and activities include administrative offices, computercenters, core service and support, building services facilities,and more. He presents new and updated design criteria based onrecent laws and regulations and supplies readers with comprehensivelists of relevant codes, regulations, standards, guidelines, andarchitectural, structural, mechanical, electrical, and plumbingcriteria. Design and Planning of Research and Clinical Laboratory Facilitiesis an excellent primer for architecture students and newcomers tothe field, as well as an indispensable single-volume reference forexperienced professionals. It is also an invaluable resource forresearchers and investigators, facility planners and managers,plant engineers, and all others involved with the design,construction, maintenance, and administration of laboratoryfacilities.
Download or read book Extending Medicare Reimbursement in Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-17 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.
Download or read book Rapid Review Laboratory Testing in Clinical Medicine written by Edward F. Goljan and published by Mosby. This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the most from your study time...with this high-yield print and electronic study package! This volume in the "Rapid Review" series - a series that is highly rated in the First Aid rankings - makes it easy for you to master laboratory testing in clinical medicine. An outline format and abundant charts, tables, and diagrams enable you to quickly access important information, and 212 review questions - presented in USMLE format - provide crucial self assessment for maximum exam and ward preparation. It's the perfect resource for medical students, residents, or practitioners who are preparing for the USMLEs, certification, or recertification. Emphasizes clinically relevant content including disease diagnosis, test selection, and test-altering variables. Provides an at-a-glance, outline-format review of all of the information you need to know. Makes studying easier with a user-friendly 2-color layout, Hi-Yield Margin Notes, and Key Points. Offers 212 USMLE-style review questions inside the book at the end of each chapter, with a full rationale for why every possible answer is right or wrong. Each of the 212 questions is available online at www.studentconsult.com - using the Rapid Review Testing Tool, providing detailed feedback on which areas you may need to study more.
Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Download or read book Clinical Research written by Robert D. Toto and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will serve as a road map for students and junior researchers seeking to successfully design, implement, and publish clinical research. It covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, investigational new drug and device applications, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. The authors provide instruction on how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on collection, quality control, and analysis of data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine's "Research Tools and Issues" feature.
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Academic Press. This book was released on 2012-05-31 with total page 798 pages. Available in PDF, EPUB and Kindle. Book excerpt: This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.
Download or read book ClinicalTrials written by Curtis L. Meinert and published by OUP USA. This book was released on 2012-03-27 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.
Download or read book Good Clinical Laboratory Practice written by David Hutchinson and published by . This book was released on 2016 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Download or read book Laboratory Studies and Clinical Studies of the Memorial Hospital for the Treatment of Cancer and Allied Diseases written by Memorial Center for Cancer and Allied Diseases (New York, N. Y.) and published by . This book was released on 1925 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt:
