The Design and Management of Medical Device Clinical Trials: Strategies and Challenges - Hardcover

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SALAH M. ABDEL-ALEEM, PhD, 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 Design, Execution, and Management of Medical Device Clinical Trials, also published by Wiley.

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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 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:

• The selection of historic controls over active control groups in clinical trials

• Challenges 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

• Ways to identify and avoid fraud and misconduct in clinical trials

• Obstacles encountered with the CE Mark process and global clinical trials

• Challenges associated with high-profile FDA PMA cases where unconventional endpoints were used as the primary objectives of these studies

The Design and Management of Medical Device Clinical Trials: Strategies and Challenges 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.

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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 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:

• The selection of historic controls over active control groups in clinical trials

• Challenges 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

• Ways to identify and avoid fraud and misconduct in clinical trials

• Obstacles encountered with the CE Mark process and global clinical trials

• Challenges associated with high-profile FDA PMA cases where unconventional endpoints were used as the primary objectives of these studies

The Design and Management of Medical Device Clinical Trials: Strategies and Challenges 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.