The design and management of medical device clinical trials: strategies and challenges

This book addresses the challenges associated with medical device clinical trials where as the author's first book, Design, Execution, and Management of Medical Device Clinical Trials, focuses on the processes and procedures of medical device clinical trials. This book is entirely devoted to discussing challenging issues facing the design and management of clinical studies such as the design of the clinical protocol, execution of study, and management of the trial. The challenges of the design of the clinical protocol, such as challenges to patient recruitment, investigator and study site selection, and study endpoint determination, are discussed. Furthermore, challenges to management of the clinical trial, i.e dealing and resolving compliance issues associated with the trial such as missing data analysis, are also discussed. This book includes in-depth knowledge of challenging issues to design and management of clinical trials with primary focus on medical device, but the application of these challenges and its resolution are also applicable to drug studies. This book provides valuable information on challenges of clinical studies and addresses how to deal with them effectively for clinical scientists, biostatisticians, and clinical data analysis experts who develop and execute scientific clinical tasks, such as clinical protocols, statistical analysis plans (SAP), final clinicalprotocol reports, etc., as well as research associates. In addition, discussing clinical challenges from the operational point of view results in a better understanding and management of the trial. With every set of challenges there are recommendations on how to deal effectively with these challenges, for example if a historic control is selected for a clinical trial, recommendations are given on justification and parameter settings for the selected historic control. Insight is provided into high profile FDA PMA cases where unconventional endpoints were used as the primary objectives of these studies, and the authors details how to recognize and avoid both fraud and misconduct in clinical trials.

• ISBN: 978-0-470-60225-6
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 268
• Fecha Publicación: 13/08/2010
• Nº Volúmenes: 1
• Idioma: Inglés