| centre for clinical studies: A Practical Guide to Managing Clinical Trials JoAnn Pfeiffer, Cris Wells, 2017-05-18 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. |
| centre for clinical studies: Brief Cognitive Behavioural Therapy for Non-Underweight Patients Glenn Waller, Hannah Turner, Madeleine Tatham, Victoria Mountford, Tracey Wade, 2019-05-10 Most people with eating disorders struggle to find an effective therapy that they can access quickly. Brief Cognitive Behavioural Therapy for Non-Underweight Patients: CBT-T for Eating Disorders presents a new form of cognitive behavioural therapy (CBT) that is brief and effective, allowing more patients to get the help that they need. CBT is a strongly supported therapy for all adults and many adolescents with eating disorders. This 10-session approach to CBT (CBT-T) is suitable for all eating disorder patients who are not severely underweight, helping adults and young adults to overcome their eating disorder. Using CBT-T with patients will allow clinicians to treat people in less time, shorten waiting lists, and see patients more quickly when they need help. It is a flexible protocol, which fits to the patient rather than making the patient fit to the therapy. Brief Cognitive Behavioural Therapy for Non-Underweight Patients provides an evidence-based protocol that can be delivered by junior or senior clinicians, helping patients to recover and go on to live a healthy life. This book will appeal to clinical psychologists, psychiatrists, psychotherapists, dietitians, nurses, and other professionals working with eating disorders. |
| centre for clinical studies: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 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 |
| centre for clinical studies: Sample Size Tables for Clinical Studies David Machin, Michael J. Campbell, Say Beng Tan, Sze Huey Tan, 2011-08-26 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. |
| centre for clinical studies: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 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. |
| centre for clinical studies: Economic Evaluation in Clinical Trials Henry A. Glick, Jalpa A. Doshi, Seema S. Sonnad, Daniel Polsky, 2014-10-02 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. |
| centre for clinical studies: Textbook of Clinical Trials David Machin, Simon Day, Sylvan Green, 2007-01-11 Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: ... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas. BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike. |
| centre for clinical studies: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| centre for clinical studies: Common Mental Health Disorders National Collaborating Centre for Mental Health (Great Britain), 2011 Bringing together treatment and referral advice from existing guidelines, this text aims to improve access to services and recognition of common mental health disorders in adults and provide advice on the principles that need to be adopted to develop appropriate referral and local care pathways. |
| centre for clinical studies: A Concise Guide to Clinical Trials Allan Hackshaw, 2011-09-07 Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies |
| centre for clinical studies: Ethics Dumping Doris Schroeder, Julie Cook, François Hirsch, Solveig Fenet, Vasantha Muthuswamy, 2017-12-04 This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training. |
| centre for clinical studies: Beyond the HIPAA Privacy Rule Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, 2009-03-24 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. |
| centre for clinical studies: Small Clinical Trials Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Small-Number-Participant Clinical Research Trials, 2001-01-01 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. |
| centre for clinical studies: Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies OECD, World Health Organization, 2019-10-17 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. |
| centre for clinical studies: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| centre for clinical studies: Routledge International Handbook of Clinical Suicide Research John R. Cutcliffe, José Santos, Paul S. Links, Juveria Zaheer, Henry G. Harder, Frank Campbell, Rod McCormick, Kari Harder, Yvonne Bergmans, Rahel Eynan, 2013-10-15 Suicide remains one of the most pressing public health concerns across the world. Expensive in terms of the human cost and associated suffering, the economic costs, the social costs and the spiritual costs, it affects millions of people every year. This important reference work collects together a wide range of research around suicide and suicide prevention, in order to guide future research and provide guidance for professionals about the best way to respond meaningfully to suicidal patients. Responding to the need for multi-disciplinary and international research to deepen our understanding of suicide, it demonstrates where our knowledge is firmly evidence-based and where new areas for research are emerging, as well as highlighting where we know little. Divided into six parts, each with its own editorial introduction and commentary, it explores research with and about survivors of suicide and indigenous populations. The remaining sections look at suicide-focused research in psychiatric nursing, psychiatry, psychology, and social work and allied health. It is of interest to all advanced students, practitioners and scholars interested in suicide and its impact and prevention. |
| centre for clinical studies: Reviewing Clinical Trials Chinese University of Hong Kong, Chinese University of Hong Kong. Clinical Trials Centre, Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc, 2010 The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide. |
| centre for clinical studies: Phase I Cancer Clinical Trials Elizabeth A. Eisenhauer, Chris Twelves, Marc E. Buyse, 2014-06 Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials. |
| centre for clinical studies: Cardiac Regeneration Masaki Ieda, Wolfram-Hubertus Zimmermann, 2017-10-27 This Volume of the series Cardiac and Vascular Biology offers a comprehensive and exciting, state-of-the-art work on the current options and potentials of cardiac regeneration and repair. Several techniques and approaches have been developed for heart failure repair: direct injection of cells, programming of scar tissue into functional myocardium, and tissue-engineered heart muscle support. The book introduces the rationale for these different approaches in cell-based heart regeneration and discusses the most important considerations for clinical translation. Expert authors discuss when, why, and how heart muscle can be salvaged. The book represents a valuable resource for stem cell researchers, cardiologists, bioengineers, and biomedical scientists studying cardiac function and regeneration. |
| centre for clinical studies: Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings Robyn Tate, Michael Perdices, 2019-01-15 This book is a practical resource designed for clinicians, researchers, and advanced students who wish to learn about single-case research designs. It covers the theoretical and methodological underpinnings of single-case designs, as well as their practical application in the clinical and research neurorehabilitation setting. The book briefly traces the history of single-case experimental designs (SCEDs); outlines important considerations in understanding and planning a scientifically rigorous single-case study, including internal and external validity; describes prototypical single-case designs (withdrawal-reversal designs and the medical N-of-1 trial, multiple-baseline designs, alternating-treatments designs, and changing-criterion designs) and required features to meet evidence standards, threats to internal validity, and strategies to address them; addresses data evaluation, covering visual analysis of graphed data, statistical techniques, and clinical significance; and provides a practical ten-step procedure for implementing single-case methods. Each chapter includes detailed illustrative examples from the neurorehabilitation literature. Novel features include: A focus on the neurorehabilitation setting, which is particularly suitable for single-case designs because of the complex and often unique presentation of many patients/clients. A practical approach to the planning, implementation, data analysis, and reporting of single-case designs. An appendix providing a detailed summary of many recently published SCEDs in representative domains in the neurorehabilitation field, covering basic and instrumental activities of daily living, challenging behaviours, disorders of communication and cognition, mood and emotional functions, and motor-sensory disabilities. It is valuable reading for clinicians and researchers in several disciplines working in rehabilitation, including clinical and neuropsychology, education, language and speech pathology, occupational therapy, and physical therapy. It is also an essential resource for advanced students in these fields who need a textbook for specialised courses on research methodology and use of single-case design in applied clinical and research settings. |
| centre for clinical studies: Decision Modelling for Health Economic Evaluation Andrew Briggs, Mark Sculpher, Karl Claxton, 2006-08-17 In financially constrained health systems across the world, increasing emphasis is being placed on the ability to demonstrate that health care interventions are not only effective, but also cost-effective. This book deals with decision modelling techniques that can be used to estimate the value for money of various interventions including medical devices, surgical procedures, diagnostic technologies, and pharmaceuticals. Particular emphasis is placed on the importance of the appropriate representation of uncertainty in the evaluative process and the implication this uncertainty has for decision making and the need for future research. This highly practical guide takes the reader through the key principles and approaches of modelling techniques. It begins with the basics of constructing different forms of the model, the population of the model with input parameter estimates, analysis of the results, and progression to the holistic view of models as a valuable tool for informing future research exercises. Case studies and exercises are supported with online templates and solutions. This book will help analysts understand the contribution of decision-analytic modelling to the evaluation of health care programmes. ABOUT THE SERIES: Economic evaluation of health interventions is a growing specialist field, and this series of practical handbooks will tackle, in-depth, topics superficially addressed in more general health economics books. Each volume will include illustrative material, case histories and worked examples to encourage the reader to apply the methods discussed, with supporting material provided online. This series is aimed at health economists in academia, the pharmaceutical industry and the health sector, those on advanced health economics courses, and health researchers in associated fields. |
| centre for clinical studies: The CAPRISA Clinical Trials: HIV Treatment and Prevention Quarraisha Abdool Karim, Salim S. Abdool Karim, Cheryl Baxter, 2018-04-29 Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a historical account of how each of CAPRISA’s high impact studies was created, developed, implemented, analysed and communicated. In doing so, the reader is taken on a journey that provides glimpses into the genesis of research ideas and how this ultimately leads to a range of HIV prevention and treatment studies that have impacted the global response to the HIV and TB epidemics. Comprised of 5 sections, the book details the following: HIV epidemic in South Africa and the establishment of a research centre to undertake clinical, epidemiological and laboratory research on HIV. CAPRISA’s clinical trials on HIV and HSV-2 prevention. These studies investigated the impact of tenofovir gel as topical antiretroviral pre-exposure prophylaxis (PrEP), implementation of topical PrEP through family planning clinics, conditional cash incentives for HIV prevention, HIV vaccines, and passive immunisation with broadly neutralising antibodies. CAPRISA’s research on the treatment of HIV and TB co-infection. A review of the major scientific findings from the CAPRISA studies on acute infection and genital mucosal immunology. Essential support activities for the conduct of clinical trials, including research laboratories and pharmacies, as well as establishing effective communication and sustainable structures for community engagement to maintain effective and respectful partnerships with participating communities. The book concludes with a chapter about the challenges facing future HIV prevention and treatment trials. The CAPRISA Clinical Trials: HIV Treatment and Prevention is a resource for undergraduate and postgraduate students, health care providers, doctors, decision-makers and researchers who are seeking guidance and insights on clinical trials – their creation, conduct and impact. |
| centre for clinical studies: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 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. |
| centre for clinical studies: Bad Pharma Ben Goldacre, 2014-04 Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc. |
| centre for clinical studies: Autoimmune Neurology , 2016-03-11 Autoimmune Neurology presents the latest information on autoimmune neurologic disease, the immune response to the body where organs run wild, causing the immune system to attack itself. Autoimmunity is a main element in numerous nervous system diseases and can target any structure within the central or peripheral nervous system. Over the past 20 years, significant advances in our understanding of the pathophysiology of autoimmune disorders, including the use of biomarkers has led to new diagnosis and treatment options. Neurologic conditions associated with autoimmune reactions include dementia, neuromuscular disease, epilepsy, sleep disorders, diabetes, and other common neurologic disorders and disease. This current tutorial-reference will be a must-have title for clinical neurologists, research neurologists, neuroscientists, and any medical professional working with autoimmune disease and disorders. - Includes comprehensive coverage of autoimmune neurology - Details the latest techniques for the study, diagnosis, and treatment of diseases and disorders, including dementia, neuromuscular disease, epilepsy, and sleep disorders - Presents a focused reference for clinical practitioners and the clinical neurology and neurology research communities |
| centre for clinical studies: Clinical Practice Guidelines We Can Trust Institute of Medicine, Board on Health Care Services, Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, 2011-06-16 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. |
| centre for clinical studies: Clinical Trials in Oncology, Third Edition Stephanie Green, Jacqueline Benedetti, Angela Smith, John Crowley, 2012-05-09 The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial. |
| centre for clinical studies: Textbook of Disaster Psychiatry Robert J. Ursano, Carol S. Fullerton, Lars Weisaeth, Beverley Raphael, 2017-05-23 This book presents a decade of advances in the psychological, biological and social responses to disasters, helping medics and leaders prepare and react. |
| centre for clinical studies: Users' Guides to the Medical Literature Gordon Guyatt, Drummond Rennie, Maureen O. Meade, Deborah J. Cook, 2008-03-01 The “essential” companion to the landmark Users' Guides to the Medical Literature - completely revised and updated! 5 STAR DOODY'S REVIEW! This second edition is even better than the original. Information is easier to find and the additional resources that will be available at www.JAMAevidence.com will provide readers with a one-stop source for evidence-based medicine.--Doody's Review Service Evidence-based medicine involves the careful interpretation of medical studies and its clinical application. And no resource helps you do it better-and faster-than Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. This streamlined reference distills the most clinically-relevant coverage from the parent Users' Guide Manual into one highly-focused, portable resource. Praised for its clear explanations of detailed statistical and mathematical principles, The Essentials concisely covers all the basic concepts of evidence-based medicine--everything you need to deliver optimal patient care. It's a perfect at-a-glance source for busy clinicians and students, helping you distinguish between solid medical evidence and poor medical evidence, tailor evidence-based medicine for each patient, and much more. Now in its second edition, this carry-along quick reference is more clinically relevant--and more essential--than ever! FEATURES Completely revised and updated with all new coverage of the basic issues in evidence-based medicine in patient care Abundant real-world examples drawn from the medical literature are woven throughout, and include important related principles and pitfalls in using clinical research in patient care decisions Edited by over 60 internationally recognized editors and contributors from around the globe Also look for JAMAevidence.com, a new interactive database for the best practice of evidence based medicine. |
| centre for clinical studies: Schizophrenia Bulletin , 2012 |
| centre for clinical studies: Testing Treatments Imogen Evans, Hazel Thornton, Iain Chalmers, Paul Glasziou, 2011 This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies. |
| centre for clinical studies: Clinical Trials Stuart J. Pocock, 2013-07-17 This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience. |
| centre for clinical studies: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 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. |
| centre for clinical studies: The Oxford Textbook of Clinical Research Ethics Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David D. Wendler, 2011-02 The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students. |
| centre for clinical studies: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture. |
| centre for clinical studies: ClinicalTrials Curtis L. Meinert, 2012-03-27 The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials. |
| centre for clinical studies: Cochrane Handbook for Systematic Reviews of Interventions Julian P. T. Higgins, Sally Green, 2008-11-24 Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves. |
| centre for clinical studies: Clinical Studies in Neuropsychoanalysis Revisited Christian Salas, Oliver Turnbull, Mark Solms, 2021-07-28 In the past few decades, we have accumulated an impressive amount of knowledge regarding the neural basis of the mind. One of the most important sources of this knowledge has been the in-depth study of individuals with focal brain damage and other neurological disorders. This book offers a unique perspective, in that it uses a combination of neuropsychology and psychoanalytic knowledge from diverse schools (Freudian, Kleinian, Lacanian, Relational, etc.), to explore how damage to specific areas of the brain can change the mind. Twenty years after the publication of Clinical Studies in Neuro-Psychoanalysis, this book continues the pioneering work of Mark Solms and Karen Kaplan-Solms, bringing together clinicians and researchers from all over the world to report key developments in the field. They present a rich set of new case studies, from a diverse range of brain injuries, neuropsychological impairments and even degenerative and paediatric pathologies. This volume will be of immense value to those working with neurological populations that want to incorporate psychoanalytic ideas in case formulations, as well as for those who want to introduce themselves in the neurological basis of psychoanalytic models of the mind and the broader psychoanalytic community. |
| centre for clinical studies: A National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, Committee on Cancer Clinical Trials and the NCI Cooperative Group Program, 2010-07-08 The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. |
| centre for clinical studies: Complex Interventions in Health David A. Richards, Ingalill Rahm Hallberg, 2015-04-17 Health and human services currently face a series of challenges – such as aging populations, chronic diseases and new endemics – that require highly complex responses, and take place in multiple care environments including acute medicine, chronic care facilities and the community. Accordingly, most modern health care interventions are now seen as ‘complex interventions’ – activities that contain a number of component parts with the potential for interactions between them which, when applied to the intended target population, produce a range of possible and variable outcomes. This in turn requires methodological developments that also take into account changing values and attitudes related to the situation of patients’ receiving health care. The first book to place complex interventions within a coherent system of research enquiry, this work is designed to help researchers understand the research processes involved at each stage of developing, testing, evaluating and implementing complex interventions, and assist them to integrate methodological activities to produce secure, evidence-based health care interventions. It begins with conceptual chapters which set out the complex interventions framework, discuss the interrelation between knowledge development and evidence, and explore how mixed methods research contributes to improved health. Structured around the influential UK Medical Research Council guidance for use of complex interventions, four sections, each comprised of bite-sized chapters written by multidisciplinary experts in the area, focus on: - Developing complex interventions - Assessing the feasibility of complex interventions and piloting them - Evaluating complex interventions - Implementing complex interventions. Accessible to students and researchers grappling with complex interventions, each substantive chapter includes an introduction, bulleted learning objectives, clinical examples, a summary and further reading. The perspectives of various stakeholders, including patients, families and professionals, are discussed throughout as are the economic and ethical implications of methods. A vital companion for health research, this book is suitable for readers from multidisciplinary disciplines such as medical, nursing, public health, health services research, human services and allied healthcare backgrounds. |
SRM “Centre for Clinical Trial and Research” - Sci-ROI
Mar 14, 2022 · The SRM “Centre for Clinical Trial and Research” is a state-of-the-art facility for conducting and enabling novel research. It is a 5000 square feet facility that is housed in the …
FDA Guidance: “Design Considerations for Pivotal Clinical ...
Double-masked (blinded), randomized, controlled, multi-center clinical trials (RCTs) are the “gold standard” for clinical outcome studies (but not necessarily for diagnostic clinical...
The role of a Clinical Trials Unit
What is a Clinical Trials Unit? A specialist unit set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. When is a CTU essential? …
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Clinical research may be defined as investigations involving human subjects or the use of patient samples. The scientific practices described here are generally accepted by investigators …
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Multicentre clinical trials involving a dosimetry component are becoming more prevalent in molecular radiotherapy and are essential to generate the evidence to support individualised …
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The centre has dedicated nurses engaged full time in clinical trials with exposure to a wide variety of both academic and clinical research, research of IMP and medical devices.
I. Description of Levels of Evidence, Grades and …
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Our experiences with R&D in gaining the necessary approvals for a multicentre observational study examining cleft lip and palate services in the UK highlight the principal difficulties....
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Patients and methods: Patients with newly-diagnosed MCL (MCL1, n - 37), and previously-treated MCL (MCL2, n = 50), received single-agent Rituximab, in the context of two multi-centre …
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SRM “Centre for Clinical Trial and Research” - Sci-ROI
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The Gold Book provides a roadmap for the conduct of Good Clinical Practice (GCP) based clinical studies. It has been developed to provide transparency to the process of developing, executing …
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RCSI CLINICAL RESEARCH CENTRE 10 CLINICAL TRIAL CAPABILITIES The centre has facilities to conduct phase II to phase IV clinical trials; IMP studies and clinical investigations of …
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Considerations for open-label clinical trials: design, conduct, and analysis. Karen M. Higgins, FDA/CDER/OTS/OB/DBIII, and Gregory Levi Center for Drug Evaluation and Research, Food …
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Aug 12, 2021 · • Site investigator meetings are useful for studies with more than a small number of sites • These meetings focus on issues common to all sites without too much detail on issues …
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studies and clinical endpoints. An example of the importance of such steps is shown in Tables 2 and 3 for the recent multi-centre trial of clinical IH MRS organised by Siemens [2]. These show …
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May 27, 2020 · clinical research handbook will be available for physicians and PIs starting in January 2021. This clinical handbook starts by discussing various ways for the clinical studies …
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based on recent clinical trials and clarifies previous recommendations. The guideline is a comprehensive one, addressing AIS management from acute symptoms onset in the …
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test that can quantify PSEP from the void urine. Multi-center clinical studies validated that CP/ CPPS patient’s present elevated PSEP level in urine when compared to the healthy men. Our …
Speaker Biographies – in order of event programme
suited to being part of multi-disciplinary and multi-centre clinical studies. Prof. Ntusi provides key scientific leadership globally through boards and scientific advisory committees of numerous …
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covered entity to use or disclose the individual ’s PHI for the purpose(s) and to the recipient(s) stated in the Authorization. When an Authoriza
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Retention framework for research data and records
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B. CLINICAL SECTION 324 9. Clinical phase 324 10. Clinical laboratory 325 11. Ethics 326 11.1 Independent ethics committee 326 11.2 Informed consent 326 12. Monitoring 327 13. …
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MNBA may be seen in a clinical setting where the presence of interfering conditions is more likely for the clot-based MNBA. •itor titers obtained by the clot-based Inhib MNBA were . mostly …
