Clinical Trial Design Challenges in Mood Disorders

Clinical Trial Design Challenges in Mood Disorders
Author: Mauricio Tohen,Charles Bowden,Andrew A. Nierenberg,John Geddes
Publsiher: Academic Press
Total Pages: 192
Release: 2015-01-24
ISBN: 0124051766
Category: Medical
Language: EN, FR, DE, ES & NL

Clinical Trial Design Challenges in Mood Disorders 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

Essentials for Quality and Safety Improvement in Health Care

Essentials for Quality and Safety Improvement in Health Care
Author: Christopher Ente,Michael Ukpe
Publsiher: Springer Nature
Total Pages: 217
Release: 2022
ISBN: 3030924823
Category: Health services administration
Language: EN, FR, DE, ES & NL

Essentials for Quality and Safety Improvement in Health Care Book Excerpt:

Patient safety and quality improvement in health care remain a global priority. Subpar performance in health care, however, is still common more than a decade after the christening of patient safety in Africa. The core principle of safety and quality improvement systems is to identify and assess the root cause of failures in order to learn from them and devise a means to improve and to avoid recurrence. This book is designed to encourage, facilitate and empower healthcare workers in the development and implementation of strategically driven patient safety and quality improvement initiatives for safer healthcare systems and healthcare facilities in low- and middle-income countries (LMICs) of Africa.^It also highlights some of the profound challenges and barriers to designing and implementing patient safety and quality improvement interventions or programmes in the region and reiterates the need to remain focused and determined to work out solutions with confidence and overcome these barriers. In the book, chapters highlight six essential components crucial for achieving evolutionary progress in safety and quality improvement in a healthcare system: Standard operating procedure Audit Research Safety management Quality management Evaluation Practical steps in planning and conducting these six essential components are outlined with some specific features to aid learning and facilitate their implementation. The authors have experience and expertise in the medical practice gained in Africa and a decade of knowledge and experience from consultancy work in safety and quality improvement in health care within and outside the region.^Essentials for Quality and Safety Improvement in Health Care: A Resource for Developing Countries is authored for both medical professionals and those from other professions who are interested in and enthusiastic about patient safety and healthcare quality and therefore willing to build a career in this field. It is relevant to all health institutions, health and non-health workers, and can be used as a checklist while rendering quality and safe health care.

Recent Advances in Molecular and Translational Medicine Updates in Precision Medicine

Recent Advances in Molecular and Translational Medicine  Updates in Precision Medicine
Author: Somchai Chutipongtanate
Publsiher: Bentham Science Publishers
Total Pages: 256
Release: 2021-12-13
ISBN: 9815036769
Category: Medical
Language: EN, FR, DE, ES & NL

Recent Advances in Molecular and Translational Medicine Updates in Precision Medicine Book Excerpt:

Precision medicine is a disruptive innovation with a fast-evolving pace in the healthcare ecosystem. Precision medicine enables precise diagnosis and targeted treatment by considering individual variability in the abnormalities of causative genes and molecular drivers behind biochemical mechanisms. A vast amount of data created by advanced omics technologies is a foundation of precision medicine’s success, and the implications of the findings from these technologies can potentially improve clinical outcomes. Recent Advances in Molecular and Translational Medicine: Updates in Precision Medicine presents essential information of molecular and translational research in precision medicine, with a specific focus on pediatrics. This book provides an accessible introduction to omics technologies, gives a detailed explanation of bioinformatics workflows to interpret high-throughput omics profiles for molecular diagnosis, and collects some of the cutting-edge research for precise therapeutics. Contributions to the book have been provided by experts in biomedical engineering and clinical practice, thus, bringing an informed perspective to the reader on each topic. The book is a valuable resource for postgraduate students, researchers, data scientists and clinicians interested in precision medicine, as well as researchers in the field of genetics and pediatrics who are interested in understanding the role of precision medicine in clinical practice.

Evaluating and Conducting Research in Audiology

Evaluating and Conducting Research in Audiology
Author: Vinaya Manchaiah, Eldré Beukes, Ross J. Roeser
Publsiher: Plural Publishing
Total Pages: 400
Release: 2021-02-04
ISBN: 1635502012
Category: Medical
Language: EN, FR, DE, ES & NL

Evaluating and Conducting Research in Audiology Book Excerpt:

Evaluating and Conducting Research in Audiology is the first research methods textbook that is specific to the field of audiology and designed to serve as an academic textbook for audiology graduate students. This text can also be accessible for audiology practitioners who are interested in clinical and applied research. The comprehensive coverage includes materials for multiple courses within audiology degree programs, including research methods, analysis of professional literature, evidence-based practice, and capstone research projects. Classroom tested, and written by authors who have extensive backgrounds in publishing and editing, this text provides knowledge that is required in evaluating, conducting, and disseminating research. The book is separated into three sections: (a) research methods; (b) evidence-based practice; and (c) conducting and disseminating research. Together, these sections provide a detailed coverage of the research methods that are relevant to conducting research, particularly in the field of Audiology. Key Features: * Learning outcomes at the beginning of each chapter * End of chapter reviews including key points and study questions * Audiology-specific examples, research methods, and study designs * “Golden Nugget” boxes throughout the book containing valuable information related to the critical concepts * In-depth discussion of qualitative research methods, survey research methods, and systematic reviews to motivate students and early career researchers to consider these methodologies in their research

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author: Divya Vohora,Gursharan Singh
Publsiher: Academic Press
Total Pages: 526
Release: 2017-11-14
ISBN: 0128020989
Category: Medical
Language: EN, FR, DE, ES & NL

Pharmaceutical Medicine and Translational Clinical Research Book Excerpt:

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Biomedical Research

Biomedical Research
Author: G. Jagadeesh
Publsiher: Wolters kluwer india Pvt Ltd
Total Pages: 594
Release: 2019-01-01
ISBN: 8184732007
Category: Medical
Language: EN, FR, DE, ES & NL

Biomedical Research Book Excerpt:

Specially designed for aspiring researchers, this book presents a systematic exposition of the basic principles and methodologies involved in biomedical research. The book covers the entire research process from the conception of an idea, its development, investigation and execution and finally to its publication. Various research methodologies including study design and statistical approaches to data analysis are also discussed in detail. The importance of ethics and integrity in research is highlighted extensively. In addition, the book discusses relevant issues relating to the commercialization of research innovations and outlines the steps necessary for successful entrepreneurship.

Medicine for MRCP

Medicine for MRCP
Author: Rupa Bessant,Jonathan Birns,Charlotte Ford
Publsiher: Oxford University Press
Total Pages: 936
Release: 2020-08-17
ISBN: 0191084948
Category: Medical
Language: EN, FR, DE, ES & NL

Medicine for MRCP Book Excerpt:

Medicine for MRCP provides a comprehensive review of the material that you need to pass the MRCP Parts 1 and 2 written papers. The twenty-seven chapters mapped out to the RCP syllabus, cover all areas from molecular medicine and genetics, through to medical law and ethics. Written by specialist contributors and educational experts, the content is carefully crafted to build your understanding for both papers. Each chapter begins with the basic science required for Part 1, before covering clinical medicine for Part 1, Part 2 and the PACES examinations. To ensure effective revision, material is presented in short sections with bullet lists, tables, and boxes. Over 150 drawings and photos illustrate key principles and clinical topics making them easier to retain. References to evidence-based protocols and directions to further reading allow for deeper understanding. Candidates can review their progress via the 180 end-of chapter self-assessment questions. Drawing on the authors' expertise, Medicine for MRCP is the ideal companion for the MRCP as well as a useful reference guide for practicing medical doctors.

Translational Medicine

Translational Medicine
Author: James Mittra,Christopher-Paul Milne
Publsiher: CRC Press
Total Pages: 294
Release: 2016-04-19
ISBN: 9814364843
Category: Medical
Language: EN, FR, DE, ES & NL

Translational Medicine Book Excerpt:

This book brings together a range of academic, industry and practitioner perspectives on translational medicine (TM). It enhances conceptual and practical understanding of the emergence and progress of the field and its potential impact on basic research, therapeutic development, and institutional infrastructure. In recognition of the various implications TM has for public health policy and commercial innovation, the book addresses the major systemic aspects of the field. The contributors explore the dynamic interactions and key challenges in translating new science into viable therapies for the clinic, which includes recognizing the importance of social, commercial, and regulatory environments in addition to good science.

Clinical and Translational Science

Clinical and Translational Science
Author: David Robertson,Gordon H. Williams
Publsiher: Academic Press
Total Pages: 600
Release: 2009-03-02
ISBN: 9780080920191
Category: Medical
Language: EN, FR, DE, ES & NL

Clinical and Translational Science Book Excerpt:

Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health. Clinical and Translational Science is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this resource begins with experimental design and investigative tools to set the scene for readers. It then moves on to human genetics and pharmacology with a focus on statistics, epidemiology, genomic information, drug discovery and development, and clinical trials. Finally, it turns to legal, social, and ethical issues of clinical research concluding with a discussion of future prospects to provide readers with a comprehensive view of the this developing area of science. Clinical research is one of the fastest growing fields in private practice and academic medicine with practical biological, physiological, cellular, and therapeutic applications Contributions from international leaders provide insight into background and future understanding for clinical and translational science Provides the structure for complete instruction and guidance on the subject from fundamental principles, approaches and infrastructure to human genetics, human pharmacology, research in special populations, the societal context of human research, and the future of human research

Biostatistics in Clinical Trials

Biostatistics in Clinical Trials
Author: Carol K. Redmond,Theodore Colton
Publsiher: John Wiley & Sons
Total Pages: 530
Release: 2001-04-25
ISBN: 9780471822110
Category: Medical
Language: EN, FR, DE, ES & NL

Biostatistics in Clinical Trials Book Excerpt:

The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

Research Design in Clinical Psychology

Research Design in Clinical Psychology
Author: Alan E. Kazdin
Publsiher: Cambridge University Press
Total Pages: 584
Release: 2021-08-05
ISBN: 1009002422
Category: Psychology
Language: EN, FR, DE, ES & NL

Research Design in Clinical Psychology Book Excerpt:

Research Design in Clinical Psychology helps students to achieve a thorough understanding of the entire research process – developing the idea, selecting methods, analyzing the results, and preparing the written scientific report. Drawing examples from clinical research, health, and medicine, author Alan E. Kazdin offers detailed coverage of experimental design, assessment, data evaluation and interpretation, case-control and cohort designs, and qualitative research methods. In addition to new pedagogical tools that guide students through the text, the Fifth Edition offers expanded coverage of key topic areas, such as cultural issues, scientific integrity, and recent changes in the publication and communication of research.

Translational Medicine in CNS Drug Development

Translational Medicine in CNS Drug Development
Author: George G. Nomikos,Douglas E. Feltner
Publsiher: Academic Press
Total Pages: 458
Release: 2019-06-18
ISBN: 0128031646
Category: Medical
Language: EN, FR, DE, ES & NL

Translational Medicine in CNS Drug Development Book Excerpt:

Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans. Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders Includes chapters written by international experts from industry and academia

How to Practice Academic Medicine and Publish from Developing Countries

How to Practice Academic Medicine and Publish from Developing Countries
Author: Samiran Nundy,Atul Kakar,Zulfiqar A. Bhutta
Publsiher: Springer Nature
Total Pages: 465
Release: 2021-10-23
ISBN: 9811652481
Category: Medical
Language: EN, FR, DE, ES & NL

How to Practice Academic Medicine and Publish from Developing Countries Book Excerpt:

This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.

Translational Research in Breast Cancer

Translational Research in Breast Cancer
Author: Dong-Young Noh,Wonshik Han,Masakazu Toi
Publsiher: Springer Nature
Total Pages: 630
Release: 2021-05-13
ISBN: 9813296208
Category: Medical
Language: EN, FR, DE, ES & NL

Translational Research in Breast Cancer Book Excerpt:

This book describes recent advances in translational research in breast cancer and presents emerging applications of this research that promise to have meaningful impacts on diagnosis and treatment. It introduces ideas and materials derived from the clinic that have been brought to "the bench" for basic research, as well as findings that have been applied back to "the bedside". Detailed attention is devoted to breast cancer biology and cell signaling pathways and to cancer stem cell and tumor heterogeneity in breast cancer. Various patient-derived research models are discussed, and a further focus is the role of biomarkers in precision medicine for breast cancer patients. Next-generation clinical research receives detailed attention, addressing the increasingly important role of big data in breast cancer research and a wide range of other emerging developments. An entire section is also devoted to the management of women with high-risk breast cancer. Translational Research in Breast Cancer will help clinicians and scientists to optimize their collaboration in order to achieve the common goal of conquering breast cancer.

Journal of the National Cancer Institute

Journal of the National Cancer Institute
Author: Anonim
Publsiher: Unknown
Total Pages: 1088
Release: 2004
ISBN: 1928374650XXX
Category: Cancer
Language: EN, FR, DE, ES & NL

Journal of the National Cancer Institute Book Excerpt:

Oncology Clinical Trials

Oncology Clinical Trials
Author: William Kevin Kelly, DO,Susan Halabi, PhD
Publsiher: Springer Publishing Company
Total Pages: 600
Release: 2018-03-28
ISBN: 0826168736
Category: Medical
Language: EN, FR, DE, ES & NL

Oncology Clinical Trials Book Excerpt:

The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Biomarkers in Cancer Screening and Early Detection

Biomarkers in Cancer Screening and Early Detection
Author: Sudhir Srivastava
Publsiher: John Wiley & Sons
Total Pages: 334
Release: 2017-08-28
ISBN: 1118468805
Category: Medical
Language: EN, FR, DE, ES & NL

Biomarkers in Cancer Screening and Early Detection Book Excerpt:

Prepared by world leaders on this topic, Biomarkers in Cancer Screening and Early Detection offers a comprehensive, state-of-the-art perspective on the various research and clinical aspects of cancer biomarkers, from their discovery and development to their validation, clinical utility, and use in developing personalized cancer treatment. Offers a comprehensive, state-of-the-art perspective on the various research and clinical aspects of cancer biomarkers Provides immediately actionable information – and hopefully also inspiration – to move discovery and clinical application forward Offers vital knowledge to help develop personalized cancer treatment for individual patients with specific cancers

Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials
Author: Steven Piantadosi,Curtis L. Meinert
Publsiher: Springer Nature
Total Pages: 2573
Release: 2022-07-19
ISBN: 3319526367
Category: Mathematics
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Trials Book Excerpt:

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

How Translational Medicine Is Progressively Redefining Healthcare

How Translational Medicine Is Progressively Redefining Healthcare
Author: Fritz Dufour, MBA, DESS
Publsiher: Fritz Dufour
Total Pages: 23
Release: 2017-12-19
ISBN: 1928374650XXX
Category: Medical
Language: EN, FR, DE, ES & NL

How Translational Medicine Is Progressively Redefining Healthcare Book Excerpt:

The preliminary idea behind translational medicine, conducting biological research to treat diseases, is not a new concept. But, scientists have been serious about placing the patient at all levels of the research process – right at the basic science level phase and all the way to the bedside – since only the 1990s. Today, translational research is a scientific field, although multidisciplinary. That innovation stemmed from the discoveries of new diseases and new technologies that allow healthcare professionals to have new perspectives on how to better and more efficiently treat patients. Translational medicine is viable, and it has already proved itself in many areas. Normally, every great discovery or innovation comes with both rewards and challenges, and continuous improvement is what keeps it alive. Translational research, an innovative concept, is not impervious to that rule. This paper examines the antecedents of translational medicine and how it came about. It considers the importance of incorporating basic science, applied science or clinical research, and the patient at every turn of the processes by analyzing the importance of translational research and its direct applications. On the other hand, this paper considers the challenges faced by translational medicine in an age where healthcare costs are skyrocketing, and suggests what can be done to circumvent the downsides. Finally, because the field is relatively new and promising, the discussion that follows also considers the outlook for translational medicine, and how important it is for scientists – artificial intelligence experts, computer, or bioengineers, healthcare professionals and healthcare management professionals – to lay right now the groundwork for future generations.

Principles of Translational Science in Medicine

Principles of Translational Science in Medicine
Author: Martin Wehling
Publsiher: Academic Press
Total Pages: 494
Release: 2021-07-15
ISBN: 032399962X
Category: Science
Language: EN, FR, DE, ES & NL

Principles of Translational Science in Medicine Book Excerpt:

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields. Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization