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.

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.

100 Diagnostic Challenges In Clinical Medicine

100 Diagnostic Challenges In Clinical Medicine PDF Author: David R Ramsdale
Publisher: World Scientific Publishing Company
ISBN: 9814365289
Category : Medical
Languages : en
Pages : 256

Get Book Here

Book Description
100 Diagnostic Challenges in Clinical Medicine is composed of one hundred well-illustrated clinical scenarios and their appropriate investigations. A wide variety of specialties are covered including cardiology, neurology, dermatology, endocrinology, tropical medicine, haematology, metabolic medicine, radiology, ophthalmology, venereology, and infectious diseases. Presenting the relevant investigations corresponding to each case in an interesting and easy-to-read Q&A format concerning diagnosis and management, this book serves as an ideal, and hopefully enjoyable, study aid for medical students and junior doctors who are preparing for clinical examinations in medicine. By solving the problems posed by these challenging clinical cases, the reader will gain additional practice in diagnosis and treatment strategies.

Precision Cancer Medicine

Precision Cancer Medicine PDF Author: Sameek Roychowdhury
Publisher: Springer Nature
ISBN: 3030236374
Category : Medical
Languages : en
Pages : 196

Get Book Here

Book Description
Genomic sequencing technologies have augmented the classification of cancer beyond tissue of origin and towards a molecular taxonomy of cancer. This has created opportunities to guide treatment decisions for individual patients with cancer based on their cancer’s unique molecular characteristics, also known as precision cancer medicine. The purpose of this text will be to describe the contribution and need for multiple disciplines working together to deliver precision cancer medicine. This entails a multi-disciplinary approach across fields including molecular pathology, computational biology, clinical oncology, cancer biology, drug development, genetics, immunology, and bioethics. Thus, we have outlined a current text on each of these fields as they work together to overcome various challenges and create opportunities to deliver precision cancer medicine. As trainees and junior faculty enter their respective fields, this text will provide a framework for understanding the role and responsibility for each specialist to contribute to this team science approach.

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.

Opportunities to Address Clinical Research Workforce Diversity Needs for 2010

Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309143888
Category : Medical
Languages : en
Pages : 146

Get Book Here

Book Description
Based on a 2003 workshop, this study describes current public and private programs and recommends ways to recruit and retain more women and underrepresented minorities into clinical research, especially physician-scientists and nurses. Federal sponsors should improve data collection, evaluate existing training programs, and increase the diversity of study section review panels. Public and private sponsors should create funding mechanisms with flexible career paths, and universities and professional societies should both play enhanced roles in fostering diversity. A significant push is needed to recruit minorities into nursing and provide more clinical research training for nurse-scientists, nursing students, and nursing faculty.

Virtual Clinical Trials

Virtual Clinical Trials PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309494885
Category : Medical
Languages : en
Pages : 127

Get Book Here

Book Description
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 Challenges

Clinical Challenges PDF Author: Debbie Picone
Publisher: Routledge
ISBN: 1000256499
Category : Medical
Languages : en
Pages : 186

Get Book Here

Book Description
Nurses work across the health care system in a great variety of roles. From patient care to administration, nurses see where the pressures are, and how well we are managing to look after some of the most vulnerable people in our society. Clinical Challenges explores contemporary issues central to nurses' work. Part I explores clinical concerns such as pain and wound management, the role of the nurse practitioner, and the effects of extending life. For many years the health sector has been coping with cutbacks in government funding, and Part II examines how this impacts on the way we handle social illnesses such as suicide and drug dependence, as well as the needs of our growing ageing population. Part III looks at management issues affecting nurses including the growing use of business strategies and rhetoric in the health care system, and the introduction of information systems and of more flexible ways of working. Written by nurses working in a variety of professional roles in the system and critiqued by experts in the field, Clinical Challenges offers valuable insights for nurses at every level, including students.