Clinical Challenges

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Transforming Clinical Research in the United States

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309163358
Total Pages : 151 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Challenges in Clinical Practice

Author : Veronica Bishop
Publisher : Bloomsbury Publishing
ISBN 13 : 1403937370
Total Pages : 208 pages
Book Rating : 4.4/5 (39 download)

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Book Synopsis Challenges in Clinical Practice by : Veronica Bishop

Download or read book Challenges in Clinical Practice written by Veronica Bishop and published by Bloomsbury Publishing. This book was released on 2017-03-14 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030921646X
Total Pages : 217 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Clinical Practice Guidelines We Can Trust by : Institute of Medicine

Download or read book Clinical Practice Guidelines We Can Trust written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-16 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Challenges in Therapeutic Drug Monitoring

Author : William Clarke
Publisher : Elsevier
ISBN 13 : 9780128020258
Total Pages : 0 pages
Book Rating : 4.0/5 (22 download)

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Book Synopsis Clinical Challenges in Therapeutic Drug Monitoring by : William Clarke

Download or read book Clinical Challenges in Therapeutic Drug Monitoring written by William Clarke and published by Elsevier. This book was released on 2016-05-17 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Trial Design Challenges in Mood Disorders

Author : Mauricio Tohen
Publisher : Academic Press
ISBN 13 : 0124051766
Total Pages : 192 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Clinical Trial Design Challenges in Mood Disorders by : Mauricio Tohen

Download or read book Clinical Trial Design Challenges in Mood Disorders written by Mauricio Tohen and published by Academic Press. This book was released on 2015-01-24 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. - Summarizes common trial design problems and their solutions - Encompasses funding, subject selection, regulatory issues and more - Identifies best practices for definitive and generalizable results - Includes traditional trial designs and novel analytic techniques - Represents academia, industry, regulatory agencies, and advocacy groups

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030913319X
Total Pages : 191 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Health Professions Education by : Institute of Medicine

Download or read book Health Professions Education written by Institute of Medicine and published by National Academies Press. This book was released on 2003-07-01 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sensory Processing Challenges: Effective Clinical Work with Kids & Teens

Author : Lindsey Biel
Publisher : W. W. Norton & Company
ISBN 13 : 0393709086
Total Pages : 296 pages
Book Rating : 4.3/5 (937 download)

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Book Synopsis Sensory Processing Challenges: Effective Clinical Work with Kids & Teens by : Lindsey Biel

Download or read book Sensory Processing Challenges: Effective Clinical Work with Kids & Teens written by Lindsey Biel and published by W. W. Norton & Company. This book was released on 2014-02-03 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equipping clinicians with “sensory smarts” to treat their child clients. Many children, teens, and even adults experience sensory processing challenges including out-of-proportion reactions to certain sensory experiences that most of us find commonplace. These challenges can range from mild to severe—from difficulty tolerating fluorescent lights and discomfort with certain clothing textures, to fight-or-flight reactions to unexpected or loud noises such as sirens or automatic hand dryers, or such strong oral sensitivities that the individual can tolerate eating just a few foods. They may struggle with one or more “sensory channels," or, more often, be quickly overwhelmed by the demand to process multisensory input (especially in busy environments with competing sights, sounds, and smells), leading to poor self-regulation, acting out, and tuning out. Sensory challenges, sometimes referred to as Sensory Processing Disorder when they interfere with daily function, are frequently seen in tandem with autism, anxiety, attention disorders, oppositional defiant disorder, and other diagnoses. This book equips clinicians with all the information they need to know to recognize and understand sensory sensitivities; connect the dots between behavior and underlying sensory processing problems; when to refer and collaborate with sensory processing professionals; and essential “sensory smart” strategies that can help clients feel and function at their best at home, in school, and in the community.

Cognitive-Behavioral Therapy for Anxiety Disorders

Author : Gillian Butler
Publisher : Guilford Press
ISBN 13 : 1606238698
Total Pages : 241 pages
Book Rating : 4.6/5 (62 download)

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Book Synopsis Cognitive-Behavioral Therapy for Anxiety Disorders by : Gillian Butler

Download or read book Cognitive-Behavioral Therapy for Anxiety Disorders written by Gillian Butler and published by Guilford Press. This book was released on 2010-04-20 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

100 Diagnostic Challenges in Clinical Medicine

Author : David R. Ramsdale
Publisher : World Scientific
ISBN 13 : 9812839399
Total Pages : 256 pages
Book Rating : 4.8/5 (128 download)

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Book Synopsis 100 Diagnostic Challenges in Clinical Medicine by : David R. Ramsdale

Download or read book 100 Diagnostic Challenges in Clinical Medicine written by David R. Ramsdale and published by World Scientific. This book was released on 2009 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents one hundred clinical scenarios along with information on their investigations.

Clinical Challenges

Author : JUDY. PICONE LUMBY (DEBBIE.)
Publisher : Routledge
ISBN 13 : 9780367717698
Total Pages : 240 pages
Book Rating : 4.7/5 (176 download)

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Book Synopsis Clinical Challenges by : JUDY. PICONE LUMBY (DEBBIE.)

Download or read book Clinical Challenges written by JUDY. PICONE LUMBY (DEBBIE.) and published by Routledge. This book was released on 2021-03-31 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Role of Telehealth in an Evolving Health Care Environment

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309262011
Total Pages : 159 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis The Role of Telehealth in an Evolving Health Care Environment by : Institute of Medicine

Download or read book The Role of Telehealth in an Evolving Health Care Environment written by Institute of Medicine and published by National Academies Press. This book was released on 2012-12-20 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996, the Institute of Medicine (IOM) released its report Telemedicine: A Guide to Assessing Telecommunications for Health Care. In that report, the IOM Committee on Evaluating Clinical Applications of Telemedicine found telemedicine is similar in most respects to other technologies for which better evidence of effectiveness is also being demanded. Telemedicine, however, has some special characteristics-shared with information technologies generally-that warrant particular notice from evaluators and decision makers. Since that time, attention to telehealth has continued to grow in both the public and private sectors. Peer-reviewed journals and professional societies are devoted to telehealth, the federal government provides grant funding to promote the use of telehealth, and the private technology industry continues to develop new applications for telehealth. However, barriers remain to the use of telehealth modalities, including issues related to reimbursement, licensure, workforce, and costs. Also, some areas of telehealth have developed a stronger evidence base than others. The Health Resources and Service Administration (HRSA) sponsored the IOM in holding a workshop in Washington, DC, on August 8-9 2012, to examine how the use of telehealth technology can fit into the U.S. health care system. HRSA asked the IOM to focus on the potential for telehealth to serve geographically isolated individuals and extend the reach of scarce resources while also emphasizing the quality and value in the delivery of health care services. This workshop summary discusses the evolution of telehealth since 1996, including the increasing role of the private sector, policies that have promoted or delayed the use of telehealth, and consumer acceptance of telehealth. The Role of Telehealth in an Evolving Health Care Environment: Workshop Summary discusses the current evidence base for telehealth, including available data and gaps in data; discuss how technological developments, including mobile telehealth, electronic intensive care units, remote monitoring, social networking, and wearable devices, in conjunction with the push for electronic health records, is changing the delivery of health care in rural and urban environments. This report also summarizes actions that the U.S. Department of Health and Human Services (HHS) can undertake to further the use of telehealth to improve health care outcomes while controlling costs in the current health care environment.

Precision Cancer Medicine

Author : Sameek Roychowdhury
Publisher : Springer Nature
ISBN 13 : 3030236374
Total Pages : 196 pages
Book Rating : 4.0/5 (32 download)

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Book Synopsis Precision Cancer Medicine by : Sameek Roychowdhury

Download or read book Precision Cancer Medicine written by Sameek Roychowdhury and published by Springer Nature. This book was released on 2020-01-02 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Virtual Clinical Trials

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309494885
Total Pages : 127 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Virtual Clinical Trials by : National Academies of Sciences, Engineering, and Medicine

Download or read book Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-16 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 and Complications of IBD

Author : Miguel Regueiro
Publisher : CRC Press
ISBN 13 : 104013680X
Total Pages : 488 pages
Book Rating : 4.0/5 (41 download)

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Book Synopsis Clinical Challenges and Complications of IBD by : Miguel Regueiro

Download or read book Clinical Challenges and Complications of IBD written by Miguel Regueiro and published by CRC Press. This book was released on 2024-06-01 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physicians treating patients with Inflammatory Bowel Disease (IBD) often face challenges due to the disease itself, associated conditions, and systemic effects. Recently, new medications have been introduced that allow for more aggressive and effective treatment of IBD. With these medications come the risks of adverse side effects, and physicians must vigilantly monitor for any complications. Drs. Miguel D. Regueiro and Jason Swoger have created a unique, user-friendly book that describes how to prevent, recognize, and manage complications encountered in the care of patients with IBD. Clinical Challenges and Complications of IBD aims to provide practical and clinically oriented information to assist physicians with commonly encountered complications of the natural history of IBD, extraintestinal manifestations of IBD, general health and metabolic complications of IBD, and complications arising from both the medical and surgical treatments of IBD. Formatted to allow for quick access of the information, Clinical Challenges and Complications of IBD is organized into sections that allow physicians to both identify potential pitfalls in treatment, as well as focus on health maintenance and specific challenges, including pregnancy, nutrition, and psychological issues. Clinical pearls will be emphasized and each chapter will provide a bulleted summary, along with suggestions for future reading. Clinical Challenges and Complications of IBD is an invaluable guide for gastroenterologists, nurse practitioners, physician assistants, and gastroenterology trainees as it is a one-of-a-kind resource for recognizing and dealing with the challenges and complications in patients with IBD.

Clinical Uncertainty in Primary Care

Author : Lucia Siegel Sommers
Publisher : Springer Science & Business Media
ISBN 13 : 1461468124
Total Pages : 311 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Clinical Uncertainty in Primary Care by : Lucia Siegel Sommers

Download or read book Clinical Uncertainty in Primary Care written by Lucia Siegel Sommers and published by Springer Science & Business Media. This book was released on 2013-07-05 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Power of Colleagues What happens when primary care clinicians meet together on set aside time in their practice settings to talk about their own patients? .....Complimenting quality metrics or performance measures through discussing the actual stories of individual patients and their clinician-patient relationships In these settings, how can clinicians pool their collective experience and apply that to ‘the evidence’ for an individual patient? .....Especially for patients who do not fit the standard protocols and have vague and worrisome symptoms, poor response to treatment, unpredictable disease courses, and/or compromised abilities for shared decision making What follows when discussion about individual patients reveals system-wide service gaps and coordination limitations? .....Particularly for patients with complex clinical problems that fall outside performance monitors and quality screens How can collaborative engagement of case-based uncertainties with one’s colleagues help combat the loneliness and helplessness that PCPs can experience, no matter what model or setting in which they practice? .....And where they are expected to practice coordinated, evidence-based, EMR-directed care These questions inspired Lucia Sommers and John Launer and their international contributors to explore the power of colleagues in “Clinical Uncertainty in Primary Care: The Challenge of Collaborative Engagement” and offer antidotes to sub-optimal care that can result when clinicians go it alone. From the Foreword: “Lucia Sommers and John Launer, with the accompanying input of their contributing authors, have done a deeply insightful and close-to-exhaustive job of defining clinical uncertainty. They identify its origins, components and subtypes; demonstrate the ways in which and the extent to which it is intrinsic to medicine...and they present a cogent case for its special relationship to primary care practice...‘Clinical Uncertainty in Primary Care’ not only presents a model of collegial collaboration and support, it also implicitly legitimates it.’’ Renee Fox, Annenberg Professor Emerita of the Social Sciences, University of Pennsylvania.

Noninferiority Testing in Clinical Trials

Author : Tie-Hua Ng
Publisher : CRC Press
ISBN 13 : 1466561491
Total Pages : 212 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Noninferiority Testing in Clinical Trials by : Tie-Hua Ng

Download or read book Noninferiority Testing in Clinical Trials written by Tie-Hua Ng and published by CRC Press. This book was released on 2014-12-01 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.