Creating a Framework For Conducting Randomized Clinical Trials During Disease Outbreaks

This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples.

Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US.

This book explores alternative models of civics and citizenship education. Specifically, it uses Justice Citizens, a participatory research and film-making project, as a tool to examine young people’s ideas about active citizenship and participation in public spaces.

To provide the right supports for struggling students in grades pre-K to 12, your school team needs a thorough understanding of the skills that contribute to learning—and a systematic way to help students with a wide range of learning difficulties. This innovative planning guide is your key to identifying and prioritizing the essential skills that students with and without learning difficulties need to succeed.

Companies from startups to corporate giants face massive amounts of disruption today. Now more than ever, organizations need nimble and responsive leaders who know how to exploit the opportunities that change brings. In this insightful book, Jean Dahl, a senior executive and expert in the Lean mindset and its methods, demonstrates why you need to embrace Modern Lean principles and thinking to redefine leadership in this age of digital disruption in order to continuously evolve the Lean enterprise.