Transforming Clinical Research in the United States

Transforming Clinical Research in the United States PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151

Get Book Here

Book Description
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.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151

Get Book Here

Book Description
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 Knowledge Management

Clinical Knowledge Management PDF Author: Rajeev K. Bali
Publisher: IGI Global
ISBN: 1591403006
Category : Computers
Languages : en
Pages : 359

Get Book Here

Book Description
"This book establishes a convergence in thinking between knowledge management and knowledge engineering healthcare applications"--Provided by publisher.

Clinical Challenges in Therapeutic Drug Monitoring

Clinical Challenges in Therapeutic Drug Monitoring PDF Author: William Clarke
Publisher: Elsevier
ISBN: 9780128020258
Category : Medical
Languages : en
Pages : 0

Get Book Here

Book Description
Clinical Challenges in Therapeutic Drug Monitoring: Special Populations, Physiological Conditions and Pharmacogenomics focuses on critical issues in therapeutic drug monitoring including special requirements of therapeutic drug monitoring important to special populations (infants and children, pregnant women, elderly patients, and obese patients). The book also covers issues of free drug monitoring and common interferences in using immunoassays for therapeutic drug monitoring. This book is essential reading for any clinician, fellow, or trainee who wants to gain greater insight into the process of therapeutic drug monitoring for individual dosage adjustment and avoiding drug toxicity for certain drugs within a narrow therapeutic window. The book is written specifically for busy clinicians, fellows, and trainees who order therapeutic drug monitoring and need to get more familiar with testing methodologies, issues of interferences, and interpretation of results in certain patient populations.

Challenges in Clinical Practice

Challenges in Clinical Practice PDF Author: Veronica Bishop
Publisher: Bloomsbury Publishing
ISBN: 1403937370
Category : Medical
Languages : en
Pages : 208

Get Book Here

Book Description
Challenges in Clinical Practice aims to support nurses and other health care workers in taking the health care agenda forward. With the constant bombardment of changes in policy initiatives, and the accompanying challenges which face nurses and other health care professionals this book will be a welcome asset to a strained labour market. It addresses the key issues and critical challenges facing the health care services today such as clinical governance, managing change, supervision in practice and research based practice. Nurses represent the fastest growing users of IT and as such the importance and simplicity of IT in supporting current challenges is also explored. The demystification of IT is brilliantly executed here and useful samplers are provided. Central to all changes are the needs of clients and patients, and partnerships in care - the power bases of service provision. The complex realities of this are probed, sometimes disconcertingly, within this important text. Written and edited by key professionals in the field, this text is an invaluable resource for pre- and post-registration students, those in middle and senior management positions and all teaching staff within the health sector. It is essential reading for anyone who wants to accept the challenge of providing the best in health care services.

Clinical Practice Guidelines We Can Trust

Clinical Practice Guidelines We Can Trust PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030921646X
Category : Medical
Languages : en
Pages : 217

Get Book Here

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

Small Clinical Trials

Small Clinical Trials PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221

Get Book Here

Book Description
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.

Health Professions Education

Health Professions Education PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030913319X
Category : Medical
Languages : en
Pages : 191

Get Book Here

Book Description
The Institute of Medicine study Crossing the Quality Chasm (2001) recommended that an interdisciplinary summit be held to further reform of health professions education in order to enhance quality and patient safety. Health Professions Education: A Bridge to Quality is the follow up to that summit, held in June 2002, where 150 participants across disciplines and occupations developed ideas about how to integrate a core set of competencies into health professions education. These core competencies include patient-centered care, interdisciplinary teams, evidence-based practice, quality improvement, and informatics. This book recommends a mix of approaches to health education improvement, including those related to oversight processes, the training environment, research, public reporting, and leadership. Educators, administrators, and health professionals can use this book to help achieve an approach to education that better prepares clinicians to meet both the needs of patients and the requirements of a changing health care system.

100 Diagnostic Challenges in Clinical Medicine

100 Diagnostic Challenges in Clinical Medicine PDF Author: David R. Ramsdale
Publisher: World Scientific
ISBN: 9812839399
Category : Medical
Languages : en
Pages : 256

Get Book Here

Book Description
Presents one hundred clinical scenarios along with information on their investigations.

Cognitive-Behavioral Therapy for Anxiety Disorders

Cognitive-Behavioral Therapy for Anxiety Disorders PDF Author: Gillian Butler
Publisher: Guilford Press
ISBN: 1606238698
Category : Psychology
Languages : en
Pages : 241

Get Book Here

Book Description
Helping therapists bring about enduring change when treating clients with any anxiety disorder, this invaluable book combines expert guidance, in-depth exploration, and innovative clinical strategies. The authors draw on extensive experience and research to provide a framework for constructing lucid formulations of complex cases. They identify obstacles that frequently arise during the early, middle, and later stages of treatment and present a wide range of practical solutions. The volume demonstrates clear-cut yet flexible ways to enhance client engagement, foster metacognitive awareness, facilitate emotional processing, address low self-esteem and fear of uncertainty, and much more. Reproducible handouts and forms are included.

Improving Diagnosis in Health Care

Improving Diagnosis in Health Care PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309377722
Category : Medical
Languages : en
Pages : 473

Get Book Here

Book Description
Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.