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| clinical trial communication plan template: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| clinical trial communication plan template: 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 communication plan template: Developing Solid Oral Dosage Forms Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu, William Porter, 2009-03-10 Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: - Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms - Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies - New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development - The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards - It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter - A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies |
| clinical trial communication plan template: Dying in America Institute of Medicine, Committee on Approaching Death: Addressing Key End-of-Life Issues, 2015-03-19 For patients and their loved ones, no care decisions are more profound than those made near the end of life. Unfortunately, the experience of dying in the United States is often characterized by fragmented care, inadequate treatment of distressing symptoms, frequent transitions among care settings, and enormous care responsibilities for families. According to this report, the current health care system of rendering more intensive services than are necessary and desired by patients, and the lack of coordination among programs increases risks to patients and creates avoidable burdens on them and their families. Dying in America is a study of the current state of health care for persons of all ages who are nearing the end of life. Death is not a strictly medical event. Ideally, health care for those nearing the end of life harmonizes with social, psychological, and spiritual support. All people with advanced illnesses who may be approaching the end of life are entitled to access to high-quality, compassionate, evidence-based care, consistent with their wishes. Dying in America evaluates strategies to integrate care into a person- and family-centered, team-based framework, and makes recommendations to create a system that coordinates care and supports and respects the choices of patients and their families. The findings and recommendations of this report will address the needs of patients and their families and assist policy makers, clinicians and their educational and credentialing bodies, leaders of health care delivery and financing organizations, researchers, public and private funders, religious and community leaders, advocates of better care, journalists, and the public to provide the best care possible for people nearing the end of life. |
| clinical trial communication plan template: 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 communication plan template: New Drug Approval Process Richard A. Guarino, Richard Guarino, 2016-04-19 The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step |
| clinical trial communication plan template: Healthcare Biotechnology Dimitris Dogramatzis, 2016-04-19 Foreseeing and planning for all of the possibilities and pitfalls involved in bringing a biotechnology innovation from inception to widespread therapeutic use takes strong managerial skills and a solid grounding in biopharmaceutical research and development procedures. Unfortunately there has been a dearth of resources for this aspect of the field. |
| clinical trial communication plan template: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2002 United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, 2001 |
| clinical trial communication plan template: Leadership for Evidence-Based Innovation in Nursing and Health Professions Daniel Weberg, Sandra Davidson, 2019-09-30 Leadership for Evidence-Based Innovation in Nursing and Health Professions, Second Edition takes a patient-centered approach, discusses the perspectives on the dynamic of innovation and evidence as well as emerging competencies for leaders of healthcare innovation, making it the ideal textbook for DNP and Masters level leadership courses. |
| clinical trial communication plan template: 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 communication plan template: Life Care Planning and Case Management Across the Lifespan Tanya Rutherford-Owen, Mary Barros-Bailey, Roger O. Weed, 2023-11-23 Celebrating 25 years since its first publication, the fifth edition of this best-selling text is the most up-to-date and complete resource available on what a life care planner does, how the life care planner does it, and issues that affect the day-to-day role of a life care planner. Now featuring new material on pediatric life care planning and case management, including brachial plexus injuries and neurodevelopmental disorders, this new edition provides guidance and planning for cases across the lifespan. It begins with a series of chapters examining ten different professional specializations that often contribute to a life care plan, before providing critical information for developing life care plans for individuals with different physical, mental, and cognitive conditions including spinal cord injury, brain injury, and chronic pain. Uniquely comprehensive, the book also includes chapters on the forensic and legal context of life care planning, as well as equipment/technology, evidence-based literature/resources, and special education/special needs planning relevant to pediatric life care planning. Also including chapters dedicated to life care planning methodology and life care planning research, this is an essential resource for anyone practicing or studying life care planning or managing the needs of those requiring chronic medical care over the lifespan. |
| clinical trial communication plan template: Principles of Good Clinical Practice Michael J. McGraw, 2010 Part of RPS Pharmacy Business Administration Series, this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights. |
| clinical trial communication plan template: Basic Methods Handbook for Clinical Orthopaedic Research Volker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura, 2019-02-01 This book is designed to meet the needs of both novice and senior researchers in Orthopaedics by providing the essential, clinically relevant knowledge on research methodology that is sometimes overlooked during training. Readers will find a wealth of easy-to-understand information on all relevant aspects, from protocol design, the fundamentals of statistics, and the use of computer-based tools through to the performance of clinical studies with different levels of evidence, multicenter studies, systematic reviews, meta-analyses, and economic health care studies. A key feature is a series of typical case examples that will facilitate use of the volume as a handbook for most common research approaches and study types. Younger researchers will also appreciate the guidance on preparation of abstracts, poster and paper presentations, grant applications, and publications. The authors are internationally renowned orthopaedic surgeons with extensive research experience and the book is published in collaboration with ISAKOS. |
| clinical trial communication plan template: 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. |
| clinical trial communication plan template: Documentation of Clinical Trial Monitoring Edyta Niebrzegowska, 2019-02-28 This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out. |
| clinical trial communication plan template: The Fundamentals of Clinical Research P. Michael Dubinsky, Karen A. Henry, 2022-01-26 This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources |
| clinical trial communication plan template: Abeloff's Clinical Oncology E-Book John E. Niederhuber, James O. Armitage, James H Doroshow, Michael B. Kastan, Joel E. Tepper, 2019-01-08 Easily accessible and clinically focused, Abeloff's Clinical Oncology, 6th Edition, covers recent advances in our understanding of the pathophysiology of cancer, cellular and molecular causes of cancer initiation and progression, new and emerging therapies, current trials, and much more. Masterfully authored by an international team of leading cancer experts, it offers clear, practical coverage of everything from basic science to multidisciplinary collaboration on diagnosis, staging, treatment and follow up. - Includes new chapters on Cancer Metabolism and Clinical Trial Designs in Oncology and a standalone chapter on lifestyles and cancer prevention. - Features extensive updates including the latest clinical practice guidelines, decision-making algorithms, and clinical trial implications, as well as new content on precision medicine, genetics, and PET/CT imaging. - Includes revised diagnostic and treatment protocols for medical management, surgical considerations, and radiation oncology therapies, stressing a multispecialty, integrated approach to care. - Helps you find information quickly with updated indexing related to management recommendations, focused fact summaries, updated key points at the beginning of each chapter ideal for quick reference and board review, and algorithms for patient evaluation, diagnosis, and treatment options. - Offers more patient care coverage in disease chapters, plus new information on cancer as a chronic illness and cancer survivorship. - Discusses today's key topics such as immuno-oncology, functional imaging, precision medicine, the application of genetics in pathologic diagnosis and sub-categorization of tumors as well as the association of chronic infectious diseases such as HIV and cancer. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices. |
| clinical trial communication plan template: Clinical Research Law and Compliance Handbook John E. Steiner, 2006 Law/Ethics |
| clinical trial communication plan template: Cancer Clinical Trials: Proactive Strategies Stanley P. L. Leong, 2007-11-25 Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group. |
| clinical trial communication plan template: 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. |
| clinical trial communication plan template: Cobert's Manual of Drug Safety and Pharmacovigilance Barton Cobert, President Blcmd Associates LLC Westfield New Jersey Barton Cobert, 2011-04 Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacuetucal, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem. |
| clinical trial communication plan template: Clinical Handbook of Schizophrenia Kim Tornvall Mueser, Dilip V. Jeste, 2011-01-31 Reviewing the breadth of current knowledge on schizophrenia, this handbook provides clear, practical guidelines for effective assessment and treatment in diverse contexts. Leading authorities have contributed 61 concise chapters on all aspects of the disorder and its clinical management. In lieu of exhaustive literature reviews, each chapter summarizes the state of the science; highlights key points the busy practitioner needs to know; and lists recommended resources, including seminal research studies, invaluable clinical tools, and more. Comprehensive, authoritative, and timely, the volume will enable professionals in any setting to better understand and help their patients or clients with severe mental illness. |
| clinical trial communication plan template: 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 communication plan template: Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) Barton Cobert, William Gregory, Jean-loup Thomas, 2019-04-09 Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.Related Link(s) |
| clinical trial communication plan template: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| clinical trial communication plan template: How to Reduce Overuse in Healthcare Tijn Kool, Andrea M. Patey, Simone van Dulmen, Jeremy M. Grimshaw, 2023-08-04 HOW TO REDUCE OVERUSE IN HEALTHCARE Reduce low-value care with this practical guide Low-value care harms patients, overburdens healthcare professionals, threatens healthcare systems and damages the climate. How to Reduce Overuse in Healthcare: a practical guide is designed to provide practical guidance and tools for healthcare providers, their professional societies and policy makers developing programs to de-implement low-value or unnecessary care. This guide provides a five-step evidence and theory-based framework for developing and evaluating programs such as Choosing Wisely to reduce low-value care and improve patient outcomes. How to Reduce Overuse in Healthcare: a practical guide readers will also find: An author team involved in the leading Choosing Wisely international network Detailed analysis of how to identify potential low-value care areas, select interventions and more Practical, real-world examples at the end of each chapter illustrating examples of overuse and de-implementation How to Reduce Overuse in Healthcare: a practical guide describes the state of the art in de-implementation for healthcare professionals, healthcare administrators and policy makers looking to reduce low-value care in a more effective and evidence-based way. |
| clinical trial communication plan template: Design, Execution, and Management of Medical Device Clinical Trials Salah M. Abdel-aleem, 2009-08-19 An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices. |
| clinical trial communication plan template: Oncology Clinical Trials William Kevin Kelly, DO, Susan Halabi, PhD, 2018-03-28 The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included |
| clinical trial communication plan template: EClinical Trials Rebecca Daniels Kush, 2003 |
| clinical trial communication plan template: The Gift of Participation Kenneth Getz, 2007 Kennth Getz takes a fresh look at why participation in clinical research really matters. This book addresses what clinical participation means and how it helps to advance medical science. Practical information on subjects like insurance coverage, compensation, and tax ramifications for clinical research volunteers also is included. With a foreword written by Congressman Rick Boucher of Virginia, and a back cover endorsement from Tour de France winner and cancer survivor Lance Armstrong, offers a road map into a world many readers are just beginning to explore. |
| clinical trial communication plan template: Re-Engineering Clinical Trials Peter Schueler, Brendan Buckley, 2014-12-16 The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. - Highlights the latest paradigm-shifts and innovation advances in clinical research - Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development - Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more |
| clinical trial communication plan template: Clinical Manifestations & Assessment of Respiratory Disease - E-Book Terry Des Jardins, George G. Burton, 2023-03-28 **Selected for Doody's Core Titles® 2024 in Pulmonology** A realistic look at treating respiratory diseases! Clinical Manifestations and Assessment of Respiratory Disease, 9th Edition gives you the fundamental knowledge and understanding required to successfully assess and treat patients with respiratory diseases. This foundation helps you learn how to systematically gather relevant clinical data; make an objective evaluation; identify the desired outcome and formulate an assessment; design a safe, appropriate, and effective treatment plan; and document all the steps involved. With this knowledge, you will understand the effectiveness of performing therapies and when to adjust therapy to a desired outcome. - UNIQUE! Emphasis on clinical scenarios and critical thinking skills prepares you for real-world practice. - UNIQUE! Focus on assessment and Therapist Driven Protocols (TDPs). - UNIQUE! Overview boxes highlight the clinical manifestations for each disease. - Logically organized content is written at a user-friendly, approachable reading level for ease of use and understanding. - Case studies provide realistic examples of the respiratory therapy practitioner's role in successful patient care. - End-of-chapter self-assessment questions and answer key are available on the companion Evolve website. - NEW! Clinical Connection boxes provide real-world clinical case studies in relevant chapters. - NEW! An updated design and additional tables, boxes, and figures draw attention to key information. - UPDATED! Content includes the latest developments related to SARS and COVID-19. - UPDATED! Information on ventilators, usage, and protocols reflects current practice. - NEW! QR codes in most chapters direct to additional outside content to enhance the chapter, including audio sounds and animations. |
| clinical trial communication plan template: Journal of the National Cancer Institute , 2002 |
| clinical trial communication plan template: Social Isolation and Loneliness in Older Adults National Academies of Sciences, Engineering, and Medicine, Division of Behavioral and Social Sciences and Education, Health and Medicine Division, Board on Behavioral, Cognitive, and Sensory Sciences, Board on Health Sciences Policy, Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults, 2020-06-14 Social isolation and loneliness are serious yet underappreciated public health risks that affect a significant portion of the older adult population. Approximately one-quarter of community-dwelling Americans aged 65 and older are considered to be socially isolated, and a significant proportion of adults in the United States report feeling lonely. People who are 50 years of age or older are more likely to experience many of the risk factors that can cause or exacerbate social isolation or loneliness, such as living alone, the loss of family or friends, chronic illness, and sensory impairments. Over a life course, social isolation and loneliness may be episodic or chronic, depending upon an individual's circumstances and perceptions. A substantial body of evidence demonstrates that social isolation presents a major risk for premature mortality, comparable to other risk factors such as high blood pressure, smoking, or obesity. As older adults are particularly high-volume and high-frequency users of the health care system, there is an opportunity for health care professionals to identify, prevent, and mitigate the adverse health impacts of social isolation and loneliness in older adults. Social Isolation and Loneliness in Older Adults summarizes the evidence base and explores how social isolation and loneliness affect health and quality of life in adults aged 50 and older, particularly among low income, underserved, and vulnerable populations. This report makes recommendations specifically for clinical settings of health care to identify those who suffer the resultant negative health impacts of social isolation and loneliness and target interventions to improve their social conditions. Social Isolation and Loneliness in Older Adults considers clinical tools and methodologies, better education and training for the health care workforce, and dissemination and implementation that will be important for translating research into practice, especially as the evidence base for effective interventions continues to flourish. |
| clinical trial communication plan template: Communication Skills for Mental Health Nurses Jean Morrissey, Patrick Callaghan, 2011-04-16 An extremely informative and useable book covering many aspects of communication ... highly recommended for students and practitioners in the mental health field, whether nurses or not. Mental Health Practice Learning to communicate effectively is vital for all nurses ... This exciting new book, with an accessible and engaging style, provides nurses working in mental health, with a valuable and comprehensive introduction to successful communication. Martina Mc Guinness, Nurse Practice Development Co-ordinator, HSE Dublin, Ireland The book is thought provoking and provides examples not only of what we should be doing but also examples of what we should not to be doing. It is a text that I would have loved to have had access to in my student days and early practice and would therefore strongly recommend this book to students and indeed beginner mental health practitioners of any discipline. Sinead Frain, Clinical Nurse Specialist - Home CareBallyfermot/Lucan Mental Health Service This accessible book takes you through the core communications skills required as a novice through to a more advanced level... The inclusion of clinical scenarios and practice exercises demonstrate clearly how to apply theoretical elements whilst working in a clinical situation ... It is a very good read and a valuable tool for anyone stepping out into the world of mental health nursing! Antony Johnson, Mental Health Nursing Student, University of Salford, UK The combination of knowledgeable discussion and richly illustrated case examples makes this an innovative text and an essential resource for those who are challenged with delivering mental health care. A must read for all students. Allison Tennant, Nurse Consultant and Psychotherapist, Rampton Hospital, UK This useful book focuses on the skills that are absolutely central and essential to all mental health nursing, from basic communication skills to specific interventions and approaches. Dr Neil Brimblecombe, Director of Nursing/Chief Operating Officer, South Staffordshire & Shropshire Healthcare NHS Foundation Trust This is a fantastic book, absolutely packed with just about everything a mental health nurse needs to know about communication skills ... The succinctly written chapters cover a wide range of key communications skills and each provides clear explanations, examples from 'everyday' life and clinical practice, with opportunities to reflect on your own experiences. Highly recommended. Alan Simpson, Professor of Collaborative Mental Health Nursing, City University London, UK This practical book provides a comprehensive guide to communication in mental health nursing, with an emphasis on demonstrating the use of different skills in various clinical settings. Written by experienced mental health professionals, the book is richly illustrated with a range of clinical case examples that will be recognisable to all nurses. Centred on the communication process as a whole, the topics are carefully presented through the use of patient-nurse dialogues and exchanges which bring the subject to life. This will help you to: Develop essential communication skills Communicate confidently Use phatic communication effectively Use self-reflection in your practice Develop the ability to deal with conflict Develop empathic helping relationships Draw upon various therapeutic models of communication Communication Skills for Mental Health Nurses is ideal for all nurses and healthcare professionals seeking to improve the skills required to communicate confidently and effectively with patients, their carers and other key people involved within the care environment. |
| clinical trial communication plan template: Principles and Practice of Emergency Research Response Robert A. Sorenson, |
| clinical trial communication plan template: New Standards and Trends in the Adjuvant Management of Breast Cancer Maureen A. Major, 2000 |
| clinical trial communication plan template: National Statement on Ethical Conduct in Human Research 2023 National Health and Medical Research Council (Australia), Australian Research Council, Universities Australia, 2023 The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them--Page 6. |
| clinical trial communication plan template: The Textbook of Pharmaceutical Medicine John P. Griffin, John Posner, Geoffrey R. Barker, 2013-03-29 The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail |
| clinical trial communication plan template: Jones & Bartlett Learning's Administrative Medical Assisting Julie Ledbetter, 2020-04-23 Designed to ensure that every medical assisting graduate can quickly trade a cap and gown for a set of scrubs, Jones & Bartlett Learning's Administrative Medical Assisting, Fourth Edition is more than just a textbook—it’s an engaging, dynamic suite of learning resources designed to train medical assisting students in the administrative skills they’ll need in today’s rapidly changing health care environment. |
Communications Handbook for Clinical Trials - FHI 360
Provide practical guidance to clinical trial staf and research partners on how to anticipate and respond to the special communications challenges posed by the conduct of clinical research in …
DAC Clinical Trials Communication Template
Why: This communication plan template was developed to support effective, inclusive communication to all stakeholders, including clinical trial participants and their broader …
Clinical Trial Communication Plan Template - mdghs.com
well-structured clinical trial communication plan template acts as a roadmap, guiding clear and consistent communication throughout the trial lifecycle. This template should encompass:
Creating a best practice template for participant …
The aims of this project were to understand the current use of communication plans in clinical trials and to develop an easy-to-use communication plan template for investigators to …
Clinical Trials Project Management Series 2: Templates, Tools, …
Manual of Procedures (MOP, aka Manual of Operations): outline and guidelines for both single-site and multi-site studies. Regulatory document templates: investigational product …
TOOL 1.12 Communication Plan Template - World Health …
Jan 23, 2020 · The purpose of the communication plan is to ensure relevant, accurate, and consistent information about the survey is provided to all involved parties, ensuring their timely …
Communications and marketing strategy: guidance for CTNs
Robinson, E. T., et al. Communications handbook for clinical trials: strategies, tips, and tools to manage controversy, convey your message, and disseminate results.
CTTI Recommendations: Planning for Successful Trial …
The following recommendations provide recommendations for enhancing recruitment through thoughtful improvement of trial design, protocol development, trial feasibility, site selection, …
44 Communications Handbook for Clinical Trials - FHI 360
Based on the strategic communications plan you developed before your trial began (see Chapter 3), you can develop systems and use routine methods to ensure regular communica-tion with …
Clinical Trials Protocol Template - Marshall University
This Clinical Trial Protocol Template is a suggested format for Phase 2 or 3 clinical trials supported by the National Institutes of Health (NIH) that are being conducted under a Food …
Clinical Trial Communication Plan Template
well-structured clinical trial communication plan template acts as a roadmap, guiding clear and consistent communication throughout the trial lifecycle. This template should encompass:
Clinical study protocol template - ClinicalTrials.gov
The study will also evaluate the early efficacy of the treatment at the first scheduled clinical visit after starting a treatment (i.e., at week 4) and investigate the remission status of all patients at …
Communications Handbook for Clinical Trials. Chapter Three: …
In the introduction to your communications plan, describe the topic and the research study in one or two paragraphs. State why your research is important, and why it is being conducted in this …
Clinical Interventional Study Protocol Template
Sep 21, 2022 · The goal of this template is to provide a general format applicable to all single- and multicenter clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).
Clinical study protocol template
Electronic data capture (EDC) is the electronic acquisition of clinical study data using data collection systems, such as Web-based applications, interactive voice response systems and …
Communications Handbook for Clinical Trials. Chapter Six: …
When planning for the dissemination of the trial’s results, you should revisit your initial communi-cations strategy in light of specific needs and any new opportunities: n Goal: What efect do …
Clinical study protocol template
Subject information collected by the Investigator that is transferred to Novartis for the purpose of the clinical trial. This data includes subject identifier information, study information and...
Clinical study protocol template
Review of the 52-week FIR led to an urgent safety communication based on an increased incidence of intraocular inflammation (IOI) and related adverse events including retinal …
Clinical study protocol template
Study objectives 2.1 Primary objective To evaluate the clinical response in Cw6-negative and Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area …
Clinical study protocol template
Sep 25, 2020 · Clinical Trial Protocol CAIN457A2311 / NCT03668613 A randomized, open-label, multicenter trial to assess the efficacy of subcutaneous secukinumab after twelve weeks of …
Communications Handbook for Clinical Trials - FHI 360
Provide practical guidance to clinical trial staf and research partners on how to anticipate and respond to the special communications challenges posed by the conduct of clinical research in …
DAC Clinical Trials Communication Template
Why: This communication plan template was developed to support effective, inclusive communication to all stakeholders, including clinical trial participants and their broader …
Clinical Trial Communication Plan Template - mdghs.com
well-structured clinical trial communication plan template acts as a roadmap, guiding clear and consistent communication throughout the trial lifecycle. This template should encompass:
Creating a best practice template for participant …
The aims of this project were to understand the current use of communication plans in clinical trials and to develop an easy-to-use communication plan template for investigators to …
Clinical Trials Project Management Series 2: Templates, Tools, …
Manual of Procedures (MOP, aka Manual of Operations): outline and guidelines for both single-site and multi-site studies. Regulatory document templates: investigational product …
TOOL 1.12 Communication Plan Template - World Health …
Jan 23, 2020 · The purpose of the communication plan is to ensure relevant, accurate, and consistent information about the survey is provided to all involved parties, ensuring their timely …
Communications and marketing strategy: guidance for CTNs
Robinson, E. T., et al. Communications handbook for clinical trials: strategies, tips, and tools to manage controversy, convey your message, and disseminate results.
CTTI Recommendations: Planning for Successful Trial …
The following recommendations provide recommendations for enhancing recruitment through thoughtful improvement of trial design, protocol development, trial feasibility, site selection, …
44 Communications Handbook for Clinical Trials - FHI 360
Based on the strategic communications plan you developed before your trial began (see Chapter 3), you can develop systems and use routine methods to ensure regular communica-tion with …
Clinical Trials Protocol Template - Marshall University
This Clinical Trial Protocol Template is a suggested format for Phase 2 or 3 clinical trials supported by the National Institutes of Health (NIH) that are being conducted under a Food …
Clinical Trial Communication Plan Template
well-structured clinical trial communication plan template acts as a roadmap, guiding clear and consistent communication throughout the trial lifecycle. This template should encompass:
Clinical study protocol template - ClinicalTrials.gov
The study will also evaluate the early efficacy of the treatment at the first scheduled clinical visit after starting a treatment (i.e., at week 4) and investigate the remission status of all patients at …
Communications Handbook for Clinical Trials. Chapter Three: …
In the introduction to your communications plan, describe the topic and the research study in one or two paragraphs. State why your research is important, and why it is being conducted in this …
Clinical Interventional Study Protocol Template
Sep 21, 2022 · The goal of this template is to provide a general format applicable to all single- and multicenter clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).
Clinical study protocol template
Electronic data capture (EDC) is the electronic acquisition of clinical study data using data collection systems, such as Web-based applications, interactive voice response systems and …
Communications Handbook for Clinical Trials. Chapter Six: …
When planning for the dissemination of the trial’s results, you should revisit your initial communi-cations strategy in light of specific needs and any new opportunities: n Goal: What efect do …
Clinical study protocol template
Subject information collected by the Investigator that is transferred to Novartis for the purpose of the clinical trial. This data includes subject identifier information, study information and...
Clinical study protocol template
Review of the 52-week FIR led to an urgent safety communication based on an increased incidence of intraocular inflammation (IOI) and related adverse events including retinal …
Clinical study protocol template
Study objectives 2.1 Primary objective To evaluate the clinical response in Cw6-negative and Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area …
Clinical study protocol template
Sep 25, 2020 · Clinical Trial Protocol CAIN457A2311 / NCT03668613 A randomized, open-label, multicenter trial to assess the efficacy of subcutaneous secukinumab after twelve weeks of …
