Clinical Research


Book Description

"Clinical and translational research is a crucial link to the improvement of clinical care and practice. Many of the elements that are involved--physicians, nurses, pharmacists, laboratory testing, medical records--are also involved in the delivery of care to patients. Yet in the conduct of clinical research, these elements are arrayed in different configurations and constrained by rules and regulations that are distinct from those that guide the practice of medicine. In parallel with these considerations, the conduct of clinical research demands a specific skill set. Specialized tools are required to formulate and design informative clinical trials and to interpret the findings from such experiments"--Provided by publisher.




Clinical Research


Book Description

This book will serve as a road map for students and junior researchers seeking to successfully design, implement, and publish clinical research. It covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, investigational new drug and device applications, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. The authors provide instruction on how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on collection, quality control, and analysis of data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine's "Research Tools and Issues" feature.




Designing Clinical Research


Book Description

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.




Proposal Writing for Clinical Nursing and DNP Projects


Book Description

Amazon, 11 reviews for 5-star average: "Excellent, very helpful, to the point, concise without leaving out important details." "Really helps and is easy to understand." This practical, concise, and accessible guide for graduate students and advanced clinicians delivers step-by-step guidelines for integrating research and best evidence to produce concise, well-written project proposals. Health care professionals in advanced practice are increasingly being asked to be able to deliver clinical project proposals using best evidence for advancing quality patient care. With the same “must know” clinical scholarship tools of the first edition, this revision provides practical guidelines of common project models for developing and writing a tight proposal from start to finish while leaving room for the unique nature of most clinical project topics. The second edition includes a completely new chapter on quality improvement concepts, new project proposal abstracts, and new information specific to the DNP project from the AACN. Using the same three-part organization to walk through the intricacies of planning, writing, and completing scholarly project proposals, this new edition also adds new key features to keep readers engaged with the text and their own ongoing or forthcoming proposal. Chapters have been updated to include websites for additional learning, as well as advice from DNP students who have themselves successfully completed project proposals. Reflective questions, tips for completing proposals, exemplars, and reader activities throughout the book facilitate readers’ greater understanding of projects and subsequent proposals. New to the Second Edition: A new chapter on quality improvement concepts Advice from DNP students who have themselves completed proposals Chapter updates and edits for enhanced clarity Websites for additional learning New information specific to the DNP project based on guidance from the AACN Increased emphasis on the Project Triangle, an important foundational structure Key Features: Provides topflight guidance in proposal writing for DNP and other nursing clinical projects Details parameters for integrating scholarship with clearly communicated professional objectives Contains numerous writing prompts and questions that guide students in reflective scholarly writing Offers examples of good writing, reflective questions, and tools for self-assessment Offers helpful tips for making proposals concise yet complete




Envisioning a Transformed Clinical Trials Enterprise in the United States


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.




How to Prepare a Research Proposal


Book Description

The public assumes the researcher spends the day dreaming up and trying out creative ideas. In reality, proposal development is an invisible but critical barrier over which even a good researcher may tumble. This book is intended to lower that barrier. It should increase first-trial recognition of good ideas and ensure that rejections do not result because a proposal poorly represented either the ideas, the investigator, or both.




Implementation Research in Health


Book Description

Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.




Dissemination and Implementation Research in Health


Book Description

The definitive work in D&I research -- now completely updated and expanded The application of scientific research to the creation of evidence-based policies is a science unto itself -- and one that is never easy. Dissemination and implementation research (D&I) is the study of how scientific advances can be implemented into everyday life, and understanding how it works has never been more important for students and professionals across the scientific, academic, and governmental communities. Dissemination and Implementation Research in Health is a practical guide to making research more consequential, a collection assembled and written by today's leading D&I researchers. Readers of this book are taught to: � Evaluate the evidence base in an effective intervention � Choose a strategy that produces the greatest impact � Design an appropriate and effectual study � Track essential outcomes � Account for the barriers to uptake in communities, social service agencies, and health care facilities The challenges to moving research into practice are universal, and they're complicated by the current landscape's reliance on partnerships and multi-center research. In this light, Dissemination and Implementation Research in Health is nothing less than a roadmap to effecting change in the sciences. It will have broad utility to researchers and practitioners in epidemiology, biostatistics, behavioral science, economics, medicine, social work, psychology, and anthropology -- both today and in our slightly better future.




Knowledge Translation in Health Care


Book Description

Health care systems worldwide are faced with the challenge of improving the quality of care. Providing evidence from health research is necessary but not sufficient for the provision of optimal care and so knowledge translation (KT), the scientific study of methods for closing the knowledge-to-action gap and of the barriers and facilitators inherent in the process, is gaining significance. Knowledge Translation in Health Care explains how to use research findings to improve health care in real life, everyday situations. The authors define and describe knowledge translation, and outline strategies for successful knowledge translation in practice and policy making. The book is full of examples of how knowledge translation models work in closing the gap between evidence and action. Written by a team of authors closely involved in the development of knowledge translation this unique book aims to extend understanding and implementation worldwide. It is an introductory guide to an emerging hot topic in evidence-based care and essential for health policy makers, researchers, managers, clinicians and trainees.




The Role of Purchasers and Payers in the Clinical Research Enterprise


Book Description

In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.