Download or read book The Clinical Research Process in the Pharmaceutical Industry written by Gary M. Matoren and published by CRC Press. This book was released on 2020-08-18 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.
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.
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
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 236 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.
Download or read book Re Engineering Clinical Trials written by Peter Schueler and published by Academic Press. This book was released on 2014-12-16 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more
Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Introduction to Statistics in Pharmaceutical Clinical Trials written by Todd A. Durham and published by . This book was released on 2008-01-01 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.
Download or read book Clinical Trial Methodology written by Karl E. Peace and published by CRC Press. This book was released on 2010-07-20 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors' courses on the subject as well as the first author's more than 30 years wor
Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Download or read book Clinical Trials written by Ann Raven and published by CRC Press. This book was released on 2018-05-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides an introduction to the process of clinical drug development. It demystifies the way new medicines are discovered, tested and regulated. This book is intended for those who wich to understand the background of clinical trials from a pharmaceutical company perspective, and is suitable for clinical trials supplies technicians and pharmacists, data management staff, information officers, medical secretaries and all support staff. This second edition is updated and includes information on the practical implications of recent EC legislation.
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. 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
Download or read book Career Opportunities in Clinical Drug Research written by Rebecca Jane Anderson and published by Rebecca Anderson. This book was released on 2010 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: "It is simply amazing to me that so many of my industry coworkers stumbled upon their careers in clinical research, like I did, merely by chance. In most cases, once those opportunities were presented to us, we found fulfilling and successful careers. Undoubtedly, other eager job seekers would also find this career path attractive. If only someone would tell them about it."
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Download or read book Preclinical and Clinical Testing by the Pharmaceutical Industry 1979 written by United States. Congress. Senate. Committee on Labor and Human Resources. Subcommittee on Health and Scientific Research and published by . This book was released on 1979 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Download or read book The Essential Guide to Clinical Research and Pharma Industry written by Poorva Jain and published by Independently Published. This book was released on 2024-01-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unlock your potential in the world of drug discovery with this comprehensive handbook. Demystify complex concepts, explore key departments, and land your dream job in the dynamic pharmaceutical industry. Tired of jargon and confusing acronyms? This guide cuts through the clutter, explaining clinical research and pharma processes in clear, concise language. Dive into departments like Clinical Data Management, Clinical Research Associate, Clinical Research Coordinator, Medical Writing, Regulatory Affairs, and Clinical Operations, understanding how they work together to transform molecules into life-saving drugs. Real-world examples and vivid analogies bring science to life, making even the most technical aspects easy to grasp. More than just theory, this book is your career compass: Explore diverse job options: From Clinical Research Associates to Medical Coders, discover a variety of rewarding roles within the industry. Master the skills you need: Each department breakdown highlights essential qualifications and expertise, ensuring you're prepared for every step. Ace your interviews: Objective knowledge assessments and practical tips boost your confidence and help you shine in front of hiring managers. Whether you're a fresh graduate, a career changer, or simply curious about the inner workings of the pharma world, this book is your essential guide. Become a superhero in the fight for better health, one informative page at a time.
