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| clinical trial feasibility assessment: Reinventing Patient Recruitment Joan F. Bachenheimer, Bonnie A. Brescia, 2007 During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget. |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Field Trials of Health Interventions Peter G. Smith, Richard H. Morrow, David A. Ross, 2015 This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing. |
| clinical trial feasibility assessment: The Prevention and Treatment of Missing Data in Clinical Trials National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Panel on Handling Missing Data in Clinical Trials, 2010-12-21 Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Clinical Trial Project Management Martin Robinson, Helena Korjonen, 2008 Clinical research projects are frequently complex and may have a large element of uncertainty both during their conduct and in their final outcome. This book sets out to give tools and techniques to plan, track and conrol projects in clinical research. |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Quality of Life Assessment in Clinical Trials Maurice J. Staquet, Ron D. Hays, Peter M. Fayers, 1998 Researchers in all clinical fields are becoming increasingly aware of the importance of quality of life measurements in judging the efficacy of a given treatment, and it is becoming more common for psychological criteria to play an important role in the evaluation of therapies. In the past ten years a number of methods have been developed for carrying out such assessments. Quality of life research does however use special statistical methods which might well be unfamiliar to the clinician. Quality of life assessment in clinical trials: methods and practice explores these methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. It describes the methods used to collect and analyse quality of life data. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties. |
| clinical trial feasibility assessment: Clinical Trials Design in Operative and Non Operative Invasive Procedures Kamal M.F. Itani, Domenic J. Reda, 2017-05-16 The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Agency for Health Care Research and Quality (U.S.), 2013-02-21 This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov) |
| clinical trial feasibility assessment: Community-Based Participatory Research for Health Meredith Minkler, Nina Wallerstein, 2002-11-18 Meredith Minkler and Nina Wallerstein have brought together, in one important volume, a stellar panel of contributors who offer a comprehensive resource on the theory and application of community based participatory research. Community Based Participatory Research for Health contains information on a wide variety of topics including planning and conducting research, working with communities, promoting social change, and core research methods. The book also contains a helpful appendix of tools, guides, checklists, sample protocols, and much more. |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference. |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Dignity Therapy Harvey Max Chochinov, 2012-01-04 Maintaining dignity for patients approaching death is a core principle of palliative care. Dignity therapy, a psychological intervention developed by Dr. Harvey Max Chochinov and his internationally lauded research group, has been designed specifically to address many of the psychological, existential, and spiritual challenges that patients and their families face as they grapple with the reality of life drawing to a close. In the first book to lay out the blueprint for this unique and meaningful intervention, Chochinov addresses one of the most important dimensions of being human. Being alive means being vulnerable and mortal; he argues that dignity therapy offers a way to preserve meaning and hope for patients approaching death. With history and foundations of dignity in care, and step by step guidance for readers interested in implementing the program, this volume illuminates how dignity therapy can change end-of-life experience for those about to die - and for those who will grieve their passing. |
| clinical trial feasibility assessment: Constraint-induced Movement Therapy G. Uswatte, 2006 Constraint-Induced Movement therapy (CI therapy) is a behavioral approach to neurorehabilitation based on a program of neuroscience experiments conducted with monkeys. Evidence has accumulated to support the efficacy of CI therapy for rehabilitating hemiparetic arm use in individuals with chronic stroke. This book addresses the related topics. |
| clinical trial feasibility assessment: Clinical Trials in Neurology Bernard Ravina, Michael McDermott, 2012-04-12 Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences. |
| clinical trial feasibility assessment: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-11-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| clinical trial feasibility assessment: Clinical Trial Project Management Ashok Kumar Peepliwal, 2023-11-15 Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: Global Clinical Trials Richard Chin, Menghis Bairu, 2011-05-06 This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA |
| clinical trial feasibility assessment: PTSD in Children and Adolescents Spencer Eth, 2008-08-13 PTSD is a recently named psychiatric condition that unknown before the publication of DSM-III in 1980. The creation of this diagnosis was intensely controversial, and there continued to be considerable reluctance to apply the term to children. The 1985 landmark volume, Posttraumatic Stress Disorder in Children, edited by Spencer Eth and Robert Pynoos, helped establish the validity of this condition during childhood. Now Spencer Eth has edited PTSD in Children and Adolescents, a work that brings the field of childhood trauma in to the new century by offering fresh insights on five major topic areas in child and adolescent PTSD: Techniques for comprehensive evaluation -- details recently developed diagnostic instruments and rating scales that measure the variety and severity of traumatic symptoms in children and adolescents. Forensic aspects of traumatized children -- surveys legally pertinent issues, including abuse, reliability of traumatic memories, and credibility of child victims. Juvenile offenders and incarcerated youth -- examines the role of trauma in the lives of juvenile offenders, noting that the victimization of delinquents must be specifically addressed in order for an integrated approach to treatment to achieve effective rehabilitation. Biological treatment strategies -- systematically reviews the important role of medications for PTSD in clinical practice, including such topics as biological dysregulation, target symptoms, and the inclusion of drugs into the biopsychosocial treatment plan. The relationship between exposure to trauma in childhood and the development of psychiatric disorders in adulthood -- presents current research on the long-term prognosis of traumatized children and adolescents by analyzing the association between early traumatic exposure, biological substrates, and subsequent symptomatic morbidity. Mental health practitioners and trainees, as well as attorneys, pediatricians, and school personnel, will find this thoroughly annotated volume an invaluable roadmap in their journey toward understanding PTSD and discovering more effective treatments for traumatized children and adolescents. With its eclectic perspective and interdisciplinary format, this exceptional reference will also enhance courses in developmental psychology, social work, and education. |
| clinical trial feasibility assessment: Rare Disease Drug Development Raymond A. Huml, 2021-11-08 This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers. |
| clinical trial feasibility assessment: Clinical Research Lori A. Nesbitt, 2004 As the demand for increased knowledge and new technology continues to unfold, readers will learn how to provide excellent service to research participants with this comprehensive guide. |
| clinical trial feasibility assessment: Building the Clinical Research Workforce: Challenges, Capacities and Competencies Carolynn Thomas Jones, Barbara E. Bierer, Stephen Sonstein, Hazel Ann Smith, Denise Snyder, 2024-08-05 This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation. |
| clinical trial feasibility assessment: Global Clinical Trials Playbook Menghis Bairu, Richard Chin, 2012-04-20 Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in neglected diseases and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios |
| clinical trial feasibility assessment: Planning Health Promotion Programs L. Kay Bartholomew Eldredge, Guy S. Parcel, Gerjo Kok, Nell H. Gottlieb, Maria E. Fernández, 2011-01-25 This thoroughly revised and updated third edition of Planning Health Promotion Programs provides a powerful, practical resource for the planning and development of health education and health promotion programs. At the heart of the book is a streamlined presentation of Intervention Mapping, a useful tool for the planning and development of effective programs. The steps and tasks of Intervention Mapping offer a framework for making and documenting decisions for influencing change in behavior and environmental conditions to promote health and to prevent or improve a health problem. Planning Health Promotion Programs gives health education and promotion professionals and researchers information on the latest advances in the field, updated examples and explanations, and new illustrative case studies. In addition, the book has been redesigned to be more teachable, practical, and practitioner-friendly. |
| clinical trial feasibility assessment: Behavioral Clinical Trials for Chronic Diseases Lynda H. Powell, Kenneth E. Freedland, Peter G. Kaufmann, 2021-10-13 This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine. |
| clinical trial feasibility assessment: Biomedical Index to PHS-supported Research: pt. A. Subject access A-H , 1992 |
| clinical trial feasibility assessment: NIH Guide for Grants and Contracts , 1991 |
| clinical trial feasibility assessment: Good Clinical Practices in Pharmaceuticals Graham P. Bunn, 2024-11-26 Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted. Provides the most up‐to‐date and best practices, techniques, and methodologies in good clinical practice. Discusses applicable laws and regulations supporting GCP compliance, quality and operations. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol. |
| clinical trial feasibility assessment: 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. |
| clinical trial feasibility assessment: NIH Guide for Grants and Contracts National Institutes of Health (U.S.), 1991 |
| clinical trial feasibility assessment: An Introduction to Clinical Trials Jonathan Cook, 2023-06-13 An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research. Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the ultimate clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life. Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials. |
| clinical trial feasibility assessment: A review of UK health research funding David Sir Cooksey, 2006-12-06 This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR). |
| clinical trial feasibility assessment: Mindfulness-Based Cancer Recovery Linda Carlson, Michael Speca, 2011-02-03 A Mind-Body Approach to Healing If you have received a cancer diagnosis, you know that the hundreds of questions and concerns you have about what's to come can be as stressful as the cancer treatment itself. But research shows that if you mentally prepare yourself to handle cancer treatment by getting stress and anxiety under control, you can improve your quality of life and become an active participant in your own recovery. Created by leading psychologists specializing in oncology, the Mindfulness-Based Cancer Recovery program is based on mindfulness-based stress reduction (MBSR), a therapeutic combination of mindfulness meditation and gentle yoga now offered to cancer survivors and their loved ones in hundreds of medical centers, hospitals, and clinics worldwide. Let this book be your guide as you let go of fear and focus on getting well. With this eight-week program, you'll learn to: • Use proven MBSR skills during your treatment and recovery • Boost your immune function through meditation and healing yoga • Calm feelings of fear, uncertainty, and lack of control • Mindfully manage difficult symptoms and side effects • Discover your own capacity for healing and thriving after adversity |
| clinical trial feasibility assessment: A Dictionary of Epidemiology Miquel S. Porta, Sander Greenland, Miguel Hernán, Isabel dos Santos Silva, John M. Last, 2014 This edition is the most updated since its inception, is the essential text for students and professionals working in and around epidemiology or using its methods. It covers subject areas - genetics, clinical epidemiology, public health practice/policy, preventive medicine, health promotion, social sciences and methods for clinical research. |
| clinical trial feasibility assessment: Handbook of Neuroemergency Clinical Trials Wayne M. Alves, Brett E. Skolnick, 2006-01-18 During the 1990's, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were tested, and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors' perspectives.* Presents new perspectives on acute neuroemergency clinical trials * Includes insights from clinical pharmacology and industry perspectives* Discusses historical lessons learned from early and recent trials in acute neuroscience populations |
| clinical trial feasibility assessment: The Explain Pain Handbook David Sheridan Butler, G. Lorimer Moseley, 2015 For: People experiencing pain'The Explain Pain Handbook: Protectometer' is a personal workbook for people experiencing chronic pain. Based on the most up-to-date research, this handbook is a key element in the Explain Pain toolkit. It introduces the 'Protectometer' - a groundbreaking pain treatment tool - that helps you understand your personal pain formula, identify your DIMs (Danger in Me) and SIMs (Safety in Me) and provides six clear strategies for recovery from pain. |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn …
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to …
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
