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Author: Elizabeth A. Eisenhauer Publisher: Oxford University Press, USA ISBN: 0199359016 Category : Language Arts & Disciplines Languages : en Pages : 369
Book Description
Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials.
Author: Elizabeth A. Eisenhauer Publisher: Oxford University Press, USA ISBN: 0199359016 Category : Language Arts & Disciplines Languages : en Pages : 369
Book Description
Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials.
Author: Carolynn Thomas Jones Publisher: Frontiers Media SA ISBN: 2832551017 Category : Science Languages : en Pages : 115
Book Description
This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309253187 Category : Medical Languages : en Pages : 248
Book Description
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Author: Karen E. Woodin Publisher: CenterWatch ISBN: Category : Medical Languages : en Pages : 428
Book Description
This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.
Author: International Association for Clinical Research Nurses Publisher: ISBN: 9781558106758 Category : MEDICAL Languages : en Pages : 106
Book Description
Clinical research nursing focuses on the care of research participants and the protocols of clinical research and trials. The clinical researcher nurse (CRN) balances the needs of the participant and the requirements of research across settings. The result: exceptional, ethical, and safe care that yields reliable, valid data and findings, high quality research outcomes, and, in time, better quality health care. The premier resource for today's CRN, Clinical Research Nursing: Scope and Standards of Practice is informed by advances in this specialty's unique body of knowledge: nursing care; rese.
Author: John I. Gallin Publisher: Elsevier ISBN: 0080489567 Category : Science Languages : en Pages : 447
Book Description
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
Author: John I. Gallin Publisher: Academic Press ISBN: 0123821673 Category : Medical Languages : en Pages : 798
Book Description
This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
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.
Author: H. Michael Dreher, PhD, RN, FAAN, ANEF Publisher: Springer Publishing Company ISBN: 0826105572 Category : Medical Languages : en Pages : 505
Book Description
2011 AJN Book of the Year Winner in Advanced Practice Nursing! "This is a unique book that will be valuable to both graduate students and professional advanced practice nurses. Since the role of the DNP graduate is evolving, this is an important contribution to the field. It focuses on the developing discussion of practice and graduate degrees in the field of nursing and provides up-to-date information about the evolving and expanding roles of DNP graduate nurses." Score: 100, 5 Stars.--Doody's Medical Reviews (2013) "This outstanding and thought provoking book...provides the knowledge to not only understand the issues and role related challenges of doctoral advanced nursing practice but the inspiration to embrace the role and become a transformer of healthcare...the use of reflective responses throughout the chapters by national DNP scholars, practitioners, and experts is a gift to the field." --From the Foreword by Bernadette Mazurek Melnyk, PhD, RN, CPNP/PMHNP, FNAP, FAAN Dean and Distinguished Foundation Professor Arizona State University College of Nursing & Health Innovation Functioning as both a graduate and professional textbook, Role Development for Doctoral Advanced Nursing Practice explores the historical and evolving role of the new doctoral advanced practice registered nurse. This innovative text presents a distinctive two-part chapter organization that provides content followed by one or more Reflective Responses, which consist of commentaries that may counter or support the opinions of each chapter author. Written by well-known DNP leaders representing the diverse roles and experience of academics, administrators, and practitioners from different DNP programs, these Reflective Responses initiate thought-provoking classroom discussion. This stimulating and provocative text presents issues germane to DNP education, core competencies, and unfolding role development. It is an essential resource in DNP role development courses and courses covering contemporary DNP degree issues. Key Features: Provides background information on the evolution of the DNP degree, essential content on role theory, and what nursing "roles" are and how they are evolving Discusses how master's versus doctoral-level advanced nursing practice roles differ Focuses on the basic roles of the DNP graduate that currently predominate: practitioner, clinical executive, educator, clinical scientist, and the role of the clinical scholar Highlights how the DNP can use his or her new competencies to function at a higher level Covers the diverse skills that comprise the doctoral APRN and doctoral APN role, including leadership content, negotiation skills, leveraging technology to support doctoral advanced level practice, and more
Author: Elizabeth A. Eisenhauer
Author: Elizabeth A. Eisenhauer
Author: Carolynn Thomas Jones
Author: Institute of Medicine
Author: Karen E. Woodin
Author: International Association for Clinical Research Nurses
Author: John I. Gallin
Author: John I. Gallin
Author: Institute of Medicine
Author: H. Michael Dreher, PhD, RN, FAAN, ANEF
Author: