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Writing Clinical Research Protocols
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Book Synopsis Writing Clinical Research Protocols by : Evan DeRenzo
Download or read book Writing Clinical Research Protocols written by Evan DeRenzo and published by Elsevier. This book was released on 2005-09-08 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Book Synopsis Ethical Considerations When Preparing a Clinical Research Protocol by : Evan DeRenzo
Download or read book Ethical Considerations When Preparing a Clinical Research Protocol written by Evan DeRenzo and published by Academic Press. This book was released on 2020-06-25 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations
Book Synopsis The Clinical Trial Protocol by : Sue Fitzpatrick
Download or read book The Clinical Trial Protocol written by Sue Fitzpatrick and published by Inst of Clinical Research. This book was released on 2005-12 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Writing Your First Clinical Research Protocol by : Colleen Aldous
Download or read book Writing Your First Clinical Research Protocol written by Colleen Aldous and published by Juta. This book was released on 2011-09-01 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: Students embarking on their first clinical research protocol are often daunted by the task at hand, particularly by the statistical terminology, concepts and the choice of appropriate statistical tests. The authors understand the difficulties and pitfalls students might encounter and have written an introductory text that will make writing that first protocol 'a breeze'. Beginning with a section entitled 'Whats in it for me', which outlines the benefits of research, the text provides ideas and advice on topics such as finding the research focus, writing the proposal, considering ethical requirements, compiling a budget and writing the executive summary.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Writing Clinical Research Protocols by : Evan DeRenzo
Download or read book Writing Clinical Research Protocols written by Evan DeRenzo and published by Academic Press. This book was released on 2005-08-18 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government
Book Synopsis 9 Steps Guide on How to Write a Clinical Trial Protocol? by : K. Ashish
Download or read book 9 Steps Guide on How to Write a Clinical Trial Protocol? written by K. Ashish and published by O2 Publications. This book was released on 2014-06-01 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book "9 Steps Guide On How To Write A Clinical Trial Protocol" is specially designed for the Clinical Trial investigators, Physicians, Sponsors, healthcare students and other clinical research professionals, who are involved or keen to explore clinical research in future to develop skills to write protocol for clinical studies. The books covers the topics Essential Clinical Trial Documents, Protocol Structure, Type of Research Studies, Trial Design Consideration, Ethical Consideration, Elementary Statistics, Randomization and its type, Blinding, Sample Sizing etc.The book is designed and written in a manner so that a reader can understand overall protocol writing and the essential element involved in it. We hope that the book would guide the readers to understand the overall process of protocol writing and impart essential skills involved in it.
Book Synopsis Medical Writing by : Robert B. Taylor
Download or read book Medical Writing written by Robert B. Taylor and published by Springer Science & Business Media. This book was released on 2011-08-17 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of this book (titled “The Clinician’s Guide to Medical Writing”) has become a standard in its field and remains an indispensible reference for any clinician, academic physician, or health professional who wishes to hone their writing skills. However, since its publication in 2004, significant changes have taken place in the way medical professionals communicate with each other and the world. Medical Writing: A Guide for Clinicians and Academicians, 2e retains all of the fundamental writing advice of the first edition and has been expanded to include two brand new chapters: How to Write a Research Protocol (including why a research project needs a written protocol, elements of the research protocol and common problems) How to Write a Grant Proposal (including sections on government and private grant funding sources, what you need to know about grant writing, and elements of a successful grant proposal) New information is also included throughout the book on becoming a successful writer, medical tables and figures, conflict of interest and disclosures, how to review a scientific article, statistical analysis, “pay-to-publish” journal publishing, electronic submission of manuscripts, issues in medical publishing and the future of medical writing and publication. New appendices address commonly encountered research and statistical terms and memorable aphorisms regarding writing, medical and otherwise.
Book Synopsis Ethical Considerations When Preparing a Clinical Research Protocol by : Evan DeRenzo
Download or read book Ethical Considerations When Preparing a Clinical Research Protocol written by Evan DeRenzo and published by Academic Press. This book was released on 2020-06-12 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations
Book Synopsis A Practical Guide for Health Researchers by : M. F. Fathalla
Download or read book A Practical Guide for Health Researchers written by M. F. Fathalla and published by WHOROEM. This book was released on 2004 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health researchers, the intended audience of this book, are not limited to scientists pursuing a research career. They include health professionals, administrators, policymakers and non-governmental organizations, among others, who can and should use the scientific method to guide their work for improving the health of individuals and communities. Even if they do not pursue much research themselves, they need to grasp the principles of the scientific method, to understand the value and also the limitations of science, and to be able to assess and evaluate results of research before applying them. This book includes the following chapters: Introduction and overview; ethics in health research; what research to do; planning the research; writing the research protocol; submitting a research proposal; implementing the research project; describing and analysing the research results; communicating research; guidelines on writing a scientific paper; publishing a scientific paper; guidelines on making a scientific presentation; assessing and evaluating research.
Book Synopsis Principles of Research Methodology by : Phyllis G. Supino
Download or read book Principles of Research Methodology written by Phyllis G. Supino and published by Springer Science & Business Media. This book was released on 2012-06-22 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.
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.
Book Synopsis The Lancet Handbook of Essential Concepts in Clinical Research by : Kenneth F. Schulz
Download or read book The Lancet Handbook of Essential Concepts in Clinical Research written by Kenneth F. Schulz and published by Elsevier Health Sciences TW. This book was released on 2006 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Lancet Handbook of Essential Concepts in Clinical Research speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes (e.g. diagnoses) of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods."--BOOK JACKET.
Book Synopsis Finding What Works in Health Care by : Institute of Medicine
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Book Synopsis How to Write Clinical Research Documents by : Kanosia
Download or read book How to Write Clinical Research Documents written by Kanosia and published by CreateSpace. This book was released on 2015-07-10 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book on "How to write Clinical Research Documents (Protocol, IB, & Study Report Writing) "Clinical Research Documentation Preparation is a humble treatise on the requirement of Clinical Research Documentation in the arena of stricter regulations and statutory compliances. This is a basic textbook on the subject matter and covers the general topic on the writing of Study Protocol, Investigator's Brochure (IB) & Clinical Research Study Report (CSR). The book is a continuous effort of the author to provide the knowledge and guidance involved in the field of Clinical Research and regulatory documentations. The book summarizes how to write these documents with ease and every step is explained in detail. There is also glossary of terms and Abbreviations given- in which detailed supporting reading material has been provided.
