{"product_id":"medical-device-clinical-trials-hardcover","title":"Medical Device Clinical Trials - Hardcover","description":"\u003cp\u003eby \u003cb\u003eSalah M. Abdel-Aleem\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eClinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.\u003c\/p\u003e\u003ch3\u003eBack Jacket\u003c\/h3\u003e\u003cp\u003e\u003cb\u003eAn in-depth and insightful presentation on dealing effectively with the challenges of clinical trials\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eClinical 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. \u003ci\u003eThe Design and Management of Medical Device Clinical Trials: Strategies and Challenges\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eRather than delve too far into statistical theory, the book outlines only the essential quantitative methods that need to be understood when working hands-on with clinical trial data and research.¿Through practical examples, common issues that arise in the development and implementation of clinical trials are discussed including: \u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe selection of historic controls over active control groups in clinical trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eChallenges to the regulations of medical devices, such as 510 K determination, determination of significant and non-significant risk devices, and similarities and differences of regulations between drugs and medical devices\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWays to identify and avoid fraud and misconduct in clinical trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eObstacles encountered with the CE Mark process and global clinical trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eChallenges associated with high-profile FDA PMA cases where unconventional endpoints were used as the primary objectives of these studies\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eThe Design and Management of Medical Device Clinical Trials: Strategies and Challenges\u003c\/i\u003e is a valuable book for courses on biostatistics, epidemiology, and clinical research methods at the upper-undergraduate and graduate level. It is also an excellent reference for professionals in any area of clinical research who would like to learn more about working with medical device clinical trials and drug and biologics trials.\u003c\/p\u003e\u003ch3\u003eAuthor Biography\u003c\/h3\u003e\u003cp\u003e\u003cb\u003eSALAH M. ABDEL-ALEEM, PhD, \u003c\/b\u003e is Senior Manager of Clinical Operations at Proteus Biomedical, Inc., a medical device and pharmaceutical company that develops therapies for cardiovascular and diabetic diseases.¿He has over twenty years of experience in academic and corporate settings and has performed clinical research tasks and activities, such as the development of clinical standard operating procedures, clinical protocols, case report forms, clinical study forms, and investigator brochures for various academic and corporate settings. Dr. Abdel-aleem is the author of \u003ci\u003eDesign, Execution, and Management of Medical Device Clinical Trials\u003c\/i\u003e, also published by Wiley.\u003c\/p\u003e\u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 272\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.8 x 9.3 x 6.1 IN\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e August 09, 2010\u003c\/div\u003e","brand":"Books by splitShops","offers":[{"title":"Default Title","offer_id":51756070076704,"sku":"9780470602256","price":179.93,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0974\/9764\/5344\/files\/2f366c3b0b8d6d912fa990a8218d2175.webp?v=1780073466","url":"https:\/\/ebocreations.com\/products\/medical-device-clinical-trials-hardcover","provider":"The E-Book Oasis LLC","version":"1.0","type":"link"}