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It is well documented that slow patient enrollment is a global contributor of studydelays. Likewise, retaining patients once enrolled can be equally arduous, but just ascritical to the completion and success of a clinical trial. In her second book on thesubject, industry expert Diana Anderson-Foster tackles for the first time the globalchallenges posed by these everyday issues and provides thoughtful analysis and strategicsolutions to minimize recruitment costs and develop successful global patient recruitmentprograms. With insight and contributions from thought-leaders in the industry, this guidealso delves into the sponsor's perspective on patient recruitment and tackles new emergingtopics including technology challenges, phase I recruiting and the role of social media. This guide is a valuable and indispensable resource for anyone involved in clinicaloperations, specifically patient recruitment and retention.
Patient recruitment and retention are clearly complex and challenging components of the clinical trials process. In the industry's foremost resource, A Guide to Patient Recruitment and Retention, the authors provide a wealth of practical advice and quantifiable examples on every aspect of patient recruitment. This book builds on the success of the original -- A Guide to Patient Recruitment -- by introducing many innovative, multi-faceted strategies designed to recruit and retain patients in clinical trials. Book jacket.
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.
During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.
This open access book explores ways to leverage information technology and machine learning to combat disease and promote health, especially in resource-constrained settings. It focuses on digital disease surveillance through the application of machine learning to non-traditional data sources. Developing countries are uniquely prone to large-scale emerging infectious disease outbreaks due to disruption of ecosystems, civil unrest, and poor healthcare infrastructure – and without comprehensive surveillance, delays in outbreak identification, resource deployment, and case management can be catastrophic. In combination with context-informed analytics, students will learn how non-traditional digital disease data sources – including news media, social media, Google Trends, and Google Street View – can fill critical knowledge gaps and help inform on-the-ground decision-making when formal surveillance systems are insufficient.
A Guide to Patient Recruitment is designed to help clinical research professionals improve the effectiveness of their patient recruitment efforts. Authored by Diana Anderson Ph.D., with contributions from 15 industry leaders, this 350-page guide offers real world, practical recruitment strategies and tactics grounded in facts and experiences. It is an invaluable resource for educating staff on patient recruitment and in managing recruitment initiatives for clinical trials. Developed in accordance with the essentials and standards of the ACCME. Exam is provided online. Topics include... Trends and issues influencing patient recruitment, retention and ethics; Benchmark data on patient volunteer demographics and recruitment costs; Effective media strategies and tactics; Budget considerations; Guidelines on establishing new recruitment and retention practices.
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.
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.