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 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.

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 Economic Evaluation in Clinical Trials written by Henry A. Glick and published by OUP Oxford. This book was released on 2014-10-02 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, drugs, devices or diagnostics. It can aid companies seeking to make claims about the cost-effectiveness of their product, as well as allowing early consideration of the economic value of therapies which may be important to improving initial adoption decisions. It is also vital for addressing the requirements of regulatory bodies. Economic Evaluation in Clinical Trials provides practical advice on how to conduct cost-effectiveness analyses in controlled trials of medical therapies. This new edition has been extensively rewritten and revised; topics discussed range from design issues such as the types of services that should be measured and price weights, to assessment of quality-adjusted life years. Illustrative materials, case histories and worked examples are included to encourage the reader to apply the methods discussed. These exercises are supported with datasets, programmes and solutions made available online.

Download or read book Clinical Practice Guidelines We Can Trust written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-16 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Download or read book Understanding Clinical Papers written by David Bowers and published by John Wiley & Sons. This book was released on 2006-05-01 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its Second Edition, this book helps to unravel the processof evidence-based practice, which requires clinicians to evaluateand collate information from the journals they read.Understanding Clinical Papers, SecondEdition uses actual papers to illustrate how tounderstand and evaluate published research, but goes beyond this toprovide an explanation of a range of important research-relatedtopics. Understanding Clinical Papers, Second Edition: Covers everything necessary to understand a clinical researchpaper Examples are illustrated and based uniquely on tables,abstracts and exerts from published clinical research papers Amazingly clear, lively, accessible style The new edition has been markedly improved and extended,containing, for example, new material on measurement scales,systematic reviews, writing a paper, statistics software andcritical appraisal “What strikes the reader... straight away isclarity… promises to become a recommended text forundergraduate and postgraduate courses." JOURNAL OF TROPICALPEDIATRICS “The writing style is amazingly clear and does notrequire formal course work in biostatistics orepidemiology…We strongly recommend it for beginners and foreasy entry into a complex domain and to experts who we think willenjoy it and who will find it useful as they teach, advise and helpothers.” QUALITY IN HEALTH CARE “What makes this book unique is that each pointpresented is illustrated with excerpts from actual papers, oftenthree or four per chapter... this is a very effective teachingdevice." JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION “This book should be an essential addition to thepersonal libraries of all health care workers who need to usearticles in journals. In these days of evidence-based medicine,this should apply to all physicians, nurses and other healthprofessionals.” ONCOLOGY Understanding Clinical Papers, Second Edition isan invaluable resource for everyone involved directly or indirectlyin health care – an ultimate guide for those who readclinical literature.

Download or read book How to Write Better Medical Papers written by Michael Hanna and published by Springer. This book was released on 2019-03-20 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book guides medical researchers through all stages of transforming their scientific data and ideas into a published paper. Many researchers in medicine, including the life sciences and health sciences, struggle to get their research written and published. Manuscripts are typically rejected and/or sent back for revisions several times before ever being published. One reason for this is that researchers have not received much instruction in the specific subjects and skills needed to write and publish scientific medical papers: research methodology, ethics, statistics, data visualization, writing, revising, and the practicalities of publishing. Instead of wasting the reader’s time discussing trivialities of punctuation, spelling, etc., this book tackles all the major scientific issues that routinely lead to manuscripts getting rejected from the journals. The section “Preparing” covers the range of methodological, ethical, and practical aspects that researchers need to address before starting to write their paper. The section “Analyzing” reviews commonplace problems in the statistical analysis and presentation, and how to resolve those problems. The section “Drafting” describes what to write in all the various parts of a paper (the Introduction, Methods, Results, Discussion, Abstract, etc.) The section “Revising” explains and illustrates how to improve the writing style of any manuscript. The section “Publishing” discusses how to navigate the peer review process and all other practical aspects of the publishing phase. This book draws on the author’s decade of experience as an independent medical writer and research consultant, but it is not written merely as the personal opinion of yet another expert. The entire book is grounded in the existing scientific and scholarly literature, with extensive references and a lengthy annotated bibliography, so readers can quickly obtain more information on any aspect they want. Thus this book provides a more evidence-based, scholarly account of how medical scientific papers should be written, in order to improve medical communication and accelerate scientific progress. After reading this entire book cover to cover, medical researchers will know how to write better quality medical papers, and they will be able to publish their work in better journals with less time and struggle. This book is essential reading for anyone conducting research in clinical medicine, life sciences, or health sciences.

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Download or read book Landmark Papers in General Surgery written by Graham MacKay and published by OUP Oxford. This book was released on 2013-02-14 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Landmark Papers in General Surgery will give surgeons, surgical trainees and other healthcare professionals an expert appraisal of key papers, and fast access to the evidence base behind current clinical practice in General Surgery. Each chapter draws together a fascinating selection of the most important clinical trials across every subspecialty within General Surgery, as selected and appraised by a panel of experts. Organized according to a common format, each discussion offers a clear structure by which to appraise the medical literature. Following a background summary of each trial, experts discuss the impact of the research and critique the methods used, giving the reader rapid understanding of the paper's place within the wider field of research. This emphasis on the tools of critical appraisal is enhanced by an introductory chapter equipping the reader with the skills required to knowledgeably appraise a research paper. For clinicians needing to keep abreast of the vast scope of medical research, this book will prove an interesting and timesaving resource, but it will also appeal to allied health professionals keen to improve the depth of their understanding of surgery. By bringing together the evidence base with expert guidance on critical appraisal, higher surgical trainees preparing for the academic and specialty sections of the FRCS exit examination will also find the text invaluable as a means of consolidating and nuancing their knowledge.

Download or read book The Health Effects of Cannabis and Cannabinoids written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-31 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.

Download or read book Clinical Pharmacy Education Practice and Research written by Dixon Thomas and published by Elsevier. This book was released on 2018-11-23 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. - Covers the core information needed for pharmacy practice courses - Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge - Designed for educational settings, but also useful as a refresher for advanced students and researchers

Download or read book Statistical Thinking in Clinical Trials written by Michael A. Proschan and published by CRC Press. This book was released on 2021-11-24 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.

Download or read book Understanding Clinical Papers written by David Bowers and published by John Wiley & Sons. This book was released on 2021-03-08 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: For two decades, Understanding Clinical Papers has been helping students and professionals understand the research that supports evidence-based practice. Now in its fourth edition, this popular introductory textbook covers every major aspect of reading and evaluating clinical research literature, from identifying the aims and objectives of a paper to analysing the data with different multivariable methods. Numerous excerpts from actual clinical research papers make learning real and immediate, supported by a unique visual approach that reinforces key points and connects examples with the chapter material. The fourth edition includes extensively revised content throughout, including four brand-new chapters covering qualitative studies, Poisson regression, studies of complex interventions, and research using previously collected data. New and updated material discusses the difference between clinical and statistical significance, the consequences of multiple testing and methods of correction, how topic guides are used to explore and explain participants' experiences, standardised guidelines for writing trials and reviews, and much more. Offering clear explanations of important research-related topics, this reader-friendly resource: Offers a clear, concise, and accessible approach to learning how to read and analyse clinical research literature Features new coverage of qualitative research, including descriptive studies, sampling and populations, and identifying, summarising, and measuring qualitative characteristics Provides new material on missing data, sub-group analysis, feasibility and pilot studies, cluster randomised trials, and adaptive trial designs Includes new tables, abstracts, and excerpts from recent clinical research literature Understanding Clinical Papers is essential reading for all healthcare professionals and students, particularly those involved in clinical work and medical research, as well as general readers wanting to improve their understanding of research literature.

Download or read book Clinical Papers written by John Halliday Croom and published by . This book was released on 1901 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.