Advertisement
| clinical trial management dashboard: 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 management dashboard: 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 management dashboard: 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 management dashboard: Leadership and Management of Clinical Trials in Creative Arts Therapy Felicity Anne Baker, 2022-10-22 This book focuses on leadership and management strategies including project management, budget planning and management, governance, building a team, and developing a strategy for successful recruitment. Many creative arts therapy researchers lack training and experience in designing and implementing large scale high impact clinical trials. This book is the first in the creative arts therapies that provides guidance on clinical trial implementation. Data management, monitoring, and intervention fidelity and development of a statistical analysis plan are outlined. Finally, the text explores development of a dissemination plan as well as how to commercialise research. |
| clinical trial management dashboard: Clinical Research Informatics Rachel Richesson, James Andrews, 2012-02-15 The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings. |
| clinical trial management dashboard: 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 management dashboard: Project Management Metrics, KPIs, and Dashboards Harold Kerzner, 2013-08-06 The new edition of Harold Kerzner's bestselling book on measuring project management performance With today's complex projects, increased stakeholder involvement, and advances in computer technology, metrics and key performance indicators (KPIs) have become increasingly integral to informed decision-making and effective project management. Project Management Metrics, KPIs, and Dashboards, Second Edition helps functional managers gain a thorough grasp of what metrics and KPIs are and how to use them, as well as an understanding of different dashboard types, design issues, and applications. Closely aligned with PMI®'s PMBOK® Guide, this new edition features: New content on topics ranging from customer relations management and project oversight to agile and SCRUM metrics, as well as metrics, pitfalls, and myths An emphasis on value, including an in-depth discussion of value-driven metrics and value-driven KPIs Full-color screen shots showing dashboards from some of the most successful project management companies PowerPoint slides and a test bank for use in seminar presentations and courses This book allows functional managers to bolster their awareness of what good metrics management really entails today—and be armed with the knowledge to measure performance more effectively. (PMI and PMBOK are registered marks of the Project Management Institute, Inc.) |
| clinical trial management dashboard: Supply Chain Planning for Clinical Trials Ryan Mills, 2024-07-03 Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: Tools for minimizing risk and expense by optimizing the relationship between supply and demand Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics. |
| clinical trial management dashboard: Neuroscience Trials of the Future National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2016-11-07 On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future. |
| clinical trial management dashboard: Discussion Framework for Clinical Trial Data Sharing Committee on Strategies for Responsible Sharing of Clinical Trial Data, Institute of Medicine, Board on Health Sciences Policy, 2014 Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing - if carried out appropriately - could lead to improved clinical care and greater public trust in clinical research and health care. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities. |
| clinical trial management dashboard: 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 management dashboard: 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 management dashboard: Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Institute of Medicine, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, 1999-07-27 In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning. |
| clinical trial management dashboard: Human Interface and the Management of Information. Interacting with Information Michael J. Smith, Gavriel Salvendy, 2011-06-24 This two-volume set LNCS 6771 and 6772 constitutes the refereed proceedings of the Symposium on Human Interface 2011, held in Orlando, FL, USA in July 2011 in the framework of the 14th International Conference on Human-Computer Interaction, HCII 2011 with 10 other thematically similar conferences. The 137 revised papers presented in the two volumes were carefully reviewed and selected from numerous submissions. The papers accepted for presentation thoroughly cover the thematic area of human interface and the management of information. The 75 papers of this first volume address the following major topics: design and development methods and tools; information and user interfaces design; visualisation techniques and applications; security and privacy; touch and gesture interfaces; adaption and personalisation; and measuring and recognising human behavior. |
| clinical trial management dashboard: 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 management dashboard: Information Dashboard Design Stephen Few, 2006 Dashboards have become popular in recent years as uniquely powerful tools for communicating important information at a glance. Although dashboards are potentially powerful, this potential is rarely realized. The greatest display technology in the world won't solve this if you fail to use effective visual design. And if a dashboard fails to tell you precisely what you need to know in an instant, you'll never use it, even if it's filled with cute gauges, meters, and traffic lights. Don't let your investment in dashboard technology go to waste. This book will teach you the visual design skills you need to create dashboards that communicate clearly, rapidly, and compellingly. Information Dashboard Design will explain how to: Avoid the thirteen mistakes common to dashboard design Provide viewers with the information they need quickly and clearly Apply what we now know about visual perception to the visual presentation of information Minimize distractions, cliches, and unnecessary embellishments that create confusion Organize business information to support meaning and usability Create an aesthetically pleasing viewing experience Maintain consistency of design to provide accurate interpretation Optimize the power of dashboard technology by pairing it with visual effectiveness Stephen Few has over 20 years of experience as an IT innovator, consultant, and educator. As Principal of the consultancy Perceptual Edge, Stephen focuses on data visualization for analyzing and communicating quantitative business information. He provides consulting and training services, speaks frequently at conferences, and teaches in the MBA program at the University ofCalifornia in Berkeley. He is also the author of Show Me the Numbers: Designing Tables and Graphs to Enlighten. Visit his website at www.perceptualedge.com. |
| clinical trial management dashboard: Fundamentals of Clinical Data Science Pieter Kubben, Michel Dumontier, Andre Dekker, 2018-12-21 This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience. |
| clinical trial management dashboard: The Role of Purchasers and Payers in the Clinical Research Enterprise Institute of Medicine, Board on Health Sciences Policy, Clinical Research Roundtable, 2002-06-14 In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective. |
| clinical trial management dashboard: Translational Research for Better Diagnosis and Treatment of Endometrial Cancer Andrea Romano, Tea Lanisnik Rizner, Andrzej Semczuk, Janina Tokarz, Dmytro Fishman, 2023-11-06 Endometrial cancer (EC) is the most frequent gynecological malignancy in the developed world. Optimal treatment of EC depends on early diagnosis and pre-operative stratification to appropriately select the extent of surgery and to plan further therapeutic approaches. Currently, endometrial histology is the gold standard for diagnosis, as there are no valid non-invasive methods available, and patient stratification is based on histopathology and surgical findings. |
| clinical trial management dashboard: 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 management dashboard: 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 management dashboard: Biomarkers in Inflammatory Bowel Diseases Nik Sheng Ding, Peter De Cruz, 2019-05-13 This book provides a comprehensive and complete overview of biomarkers in clinical practice for inflammatory bowel disease (IBD) bringing together the literature in a clear and concise manner. The book bridges the gap between growing knowledge at the bench and current and future applications of biomarkers in clinical practice. The central structure of the book focuses on prognostic and predictive biomarkers in IBD with an emphasis on the fields of research and scientific techniques (genomics, proteomics and metabonomics) that have led to biomarker discovery and places these biomarkers within a clinical context to help understand their utility in clinical practice. This book will be of use to clinicians who have an interest in using biomarkers in clinical practice as well as clinician researchers and scientists involved in the biomarker research pipeline. The author team comprises experts from around the world in order to bring together the literature in an effort to inform clinicians and researchers about the current state-of-the art in biomarker discovery. It is intended to assist future research efforts and indicate how biomarkers might be best applied to clinical practice both at present and in the future. |
| clinical trial management dashboard: Software Innovations in Clinical Drug Development and Safety Chakraborty, Partha, 2015-10-02 In light of the rising cost of healthcare and the overall challenges associated with delivering quality care to patients across regions, scientists and pharmacists are exploring new initiatives in drug discovery and design. One such initiative is the adoption of information technology and software applications to improve healthcare and pharmaceutical processes. Software Innovations in Clinical Drug Development and Safety is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing. Taking a multi-faceted approach to the application of computational methods to pharmaceutical science, this publication is ideal for healthcare professionals, pharmacists, computer scientists, researchers, and students seeking the latest information on the architecture and design of software in clinical settings, the impact of clinical technologies on business models, and the safety and privacy of patients and patient data. This timely resource features a well-rounded discussion on topics pertaining to the integration of computational methods in pharmaceutical science and practice including, the impact of software integration on business models, patient safety concerns, software architecture and design, and data security. |
| clinical trial management dashboard: Insights in Regulatory Science: 2021 Bruno Sepodes, Peter G. M. Mol, 2022-11-04 |
| clinical trial management dashboard: Evolution of Translational Omics Institute of Medicine, Board on Health Sciences Policy, Board on Health Care Services, Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials, 2012-09-13 Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. |
| clinical trial management dashboard: Siebel Clinical Blackbook , |
| clinical trial management dashboard: Fundamentals of Decentralized Clinical Trials Anna H. Yang, |
| clinical trial management dashboard: German Medical Data Sciences: Visions and Bridges R. Röhrig, A. Timmer, H. Binder, 2017-09-26 We live in an age characterized by computerized information, but ubiquitous information technology has profoundly changed our healthcare systems and, if not adequately trained to deal with it, healthcare professionals can all too easily be overwhelmed by the complexity and magnitude of the data. This demands new skills from physicians as well as novel ways to provide medical knowledge. Selecting and assessing relevant information presents a challenge which can only be met by bridging the various disciplines in healthcare and the data sciences. This book presents the proceedings of the 62nd annual meeting of the German Association of Medical Informatics, Biometry and Epidemiology (German Medical Data Sciences – GMDS 2017): Visions and Bridges, held in Oldenburg, Germany, in September 2017. The 242 submissions to the conference included 77 full papers, of which 42 were accepted for publication here after rigorous review. These are divided into 7 sections: teaching and training; epidemiological surveillance, screening and registration; research methods; IT infrastructure for biomedical research/data integration centers; healthcare information systems; interoperability – standards, terminologies, classification; and biomedical informatics, innovative algorithms and signal processing. The book provides a vision for healthcare in the information age, and will be of interest to all those concerned with improving clinical decision making and the effectiveness and efficiency of health systems using data methods and technology. |
| clinical trial management dashboard: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| clinical trial management dashboard: Biomedical Informatics Edward H. Shortliffe, James J. Cimino, 2013-12-02 The practice of modern medicine and biomedical research requires sophisticated information technologies with which to manage patient information, plan diagnostic procedures, interpret laboratory results, and carry out investigations. Biomedical Informatics provides both a conceptual framework and a practical inspiration for this swiftly emerging scientific discipline at the intersection of computer science, decision science, information science, cognitive science, and biomedicine. Now revised and in its third edition, this text meets the growing demand by practitioners, researchers, and students for a comprehensive introduction to key topics in the field. Authored by leaders in medical informatics and extensively tested in their courses, the chapters in this volume constitute an effective textbook for students of medical informatics and its areas of application. The book is also a useful reference work for individual readers needing to understand the role that computers can play in the provision of clinical services and the pursuit of biological questions. The volume is organized so as first to explain basic concepts and then to illustrate them with specific systems and technologies. |
| clinical trial management dashboard: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for Fiscal Year 2011 United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, 2011 |
| clinical trial management dashboard: Evidence-Based Advance and Management of Drug Treatment of Infectious Diseases Yonggang Zhang, Hong Fan, Min Yang, 2021-12-06 Infectious diseases are caused by microorganisms that release toxins or invade body tissues. The most common pathogenic organisms are bacteria, viruses, fungi, protozoa, and helminths. Systemic infections usually cause fevers, chills, sweats, malaise, and occasionally headache, muscle and joint pain, or changes in mental status, and even septic shock-MODS. Infectious diseases have always threatened populations and caused great loss of life in history, but since the last century, with the discovery of antibiotics, historical trends have been reversed. It is reported that between 1990 and 2017, age-standardized disability-adjusted life year (DALY) rates decreased by 41.3% (38.8-43.5) for infectious diseases. However, in 2017, lower respiratory infections are still ranked as the third cause of DALYs. Drug therapy is the one of most critical management strategies for infectious diseases. Efficacy and safety of drug therapy should always be considered, especially in elders, neonates and immunosuppressed patients. Off-label drug therapy has been performed for complex infectious diseases, especially for new emerging infectious diseases. However, off-label drug therapy can be extremely complex: some are prone to rational use, while others are more susceptible to the issues of irrational use. With the increasing rate of publication of data in this area, new evidence for the efficacy and safety of different treatment approaches is constantly developing. Thus, rigorous analysis of such data is imperative, which will guide future clinical practice and guidelines. |
| clinical trial management dashboard: 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 management dashboard: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Mahmoud Aljurf, John A. Snowden, Patrick Hayden, Kim H. Orchard, Eoin McGrath, 2021-02-19 This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program. |
| clinical trial management dashboard: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2012 United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, 2011 |
| clinical trial management dashboard: Migraine Pain Management Stephen B. Shrewsbury, 2024-10-24 Migraine Management: Current Pharmacological and Non-pharmacological Options is a comprehensive guide to established, recent, and ongoing pharmaceuticals and device development projects. The book provides detailed information on the historical developments of migraine pain management, druggable targets, drugs action mechanisms, drugs for acute treatment and preventive care of patients, administration routes, and alternative treatments. This is the ideal reference for academic researchers interested in anti-migraine pharmacology. It will also be a perfect reference for physicians and care professionals involved in the well-being of migraine patients. - Offers a comprehensive overview of pharmacological and alternative migraine pain treatment options - Covers the historical developments and current targets for drug development and delivery routes - Provides insights into comorbidities and their impact in patient compliance to treatment |
| clinical trial management dashboard: Information Technology Based Methods for Health Behaviours A.J. Maeder, S. Champion, C. Moores, 2020-03-12 Understanding and modifying health behaviors plays an important part in healthcare. The need to change behaviors applies across a range of health contexts, from individual interventions to the clinically-delivered management of chronic diseases and rehabilitation. Telehealth or virtual care technology offers many possible advantages here, including cost-efficiency, scalability, personalization, and automated high volume data collection and analysis, but success will depend on the effectiveness of the design, implementation and deployment of IT-based methods. This book, which forms part of the Global Telehealth series, includes papers presented at Global Telehealth 2019 (GT2019), a National Symposium on the topic of IT-based Methods for Health Behaviours held in Adelaide, Australia on 5 July 2019. The 10 papers selected for inclusion here comprise only full-paper, blind peer-reviewed contributions received for the symposium and the subsequent call for further contributions. Topics range from the scientific theory of health behavior change, through technological approaches to active ageing and the implementation of the 10,000 steps project, to a discussion of digital infrastructure for the storing & sharing of internet of things, wearables and app-based research study data. The book will be of interest to all researchers, managers and healthcare practitioners working to bring about positive changes in health behavior. |
| clinical trial management dashboard: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, 2015-08-27 This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. |
| clinical trial management dashboard: Blockchain and Clinical Trial Hamid Jahankhani, Stefan Kendzierskyj, Arshad Jamal, Gregory Epiphaniou, Haider Al-Khateeb, 2019-04-08 This book aims to highlight the gaps and the transparency issues in the clinical research and trials processes and how there is a lack of information flowing back to researchers and patients involved in those trials. Lack of data transparency is an underlying theme within the clinical research world and causes issues of corruption, fraud, errors and a problem of reproducibility. Blockchain can prove to be a method to ensure a much more joined up and integrated approach to data sharing and improving patient outcomes. Surveys undertaken by creditable organisations in the healthcare industry are analysed in this book that show strong support for using blockchain technology regarding strengthening data security, interoperability and a range of beneficial use cases where mostly all respondents of the surveys believe blockchain will be important for the future of the healthcare industry. Another aspect considered in the book is the coming surge of healthcare wearables using Internet of Things (IoT) and the prediction that the current capacity of centralised networks will not cope with the demands of data storage. The benefits are great for clinical research, but will add more pressure to the transparency of clinical trials and how this is managed unless a secure mechanism like, blockchain is used. |
| clinical trial management dashboard: Cardiac Safety of Noncardiac Drugs Joel Morganroth, Ihor Gussak, 2007-10-10 Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development is designed to present the current preclinical, clinical, and regulatory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical guidance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by internationally recognized experts with academic, industrial, and regulatory experience. |
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.
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.
