The Design and Management of Medical Device Clinical Trials
Автор:Salah M. Abdel–aleem Год: 2010 Издание: [не указанo] Страниц: 250 ISBN: 9780470602256 An in–depth and insightful presentation on dealing effectively with the challenges of clinical trials Clinical trials tasks and activities are widely diverse and require specific skill sets including excellent communication and management skills as well as the ability to develop different clinical scientific documents for successful planning and execution. The Design and Management of Medical Device Clinical Trials: Strategies and Challenges provides readers with valuable information on overcoming obstacles in these three vital stages of clinical trials. Focusing primarily on medical device clinical trials, the author discusses common challenges, such as investigator and study site selection, slow study enrollment, study endpoint determination, handling compliance issues, missing data analysis, and protocol deviations. Rather than delve too far into statistical theory, the book outlines only the essential quantitative methods that need to be understood when working...