Design, Execution, and Management of Medical Device Clinical Trials
von Salah Abdel-aleemAn essential introduction to conducting the various stages ofmedical device clinical trials
Clinical research continues to be one of the most vitalcomponents of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trialsprovides a uniform methodology for conducting and managing clinicaltrials. Written in a style that is accessible to readers fromdiverse educational and professional backgrounds, this bookprovides an in-depth and broad overview for successfully performingclinical tasks and activities.
Throughout the book, practical examples compiled from both theauthor's and other researchers' previous clinical trial experiencesare discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and theselection of clinical sites and ending with the completion of thefinal clinical study report. Next, readers are guided through thedevelopment of important clinical documents, including informedconsent forms, case report forms, and study logs. A careful reviewof the Food and Drug Administration (FDA) and InternationalConference on Harmonisation (ICH) regulations applicable to medicaldevices is also featured. Additional coverage includes:
* Qualification and selection of investigators
* Study monitoring visits
* Definitions and reporting procedures for adverse events
* The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determinationand study endpoints
* The roles and responsibilities of all members of a clinicalresearch team
The book concludes with an insightful discussion of specialethical conduct for human research and challenging issues toconsider during the design of clinical studies. A glossary listsimportant clinical and statistical terms used in clinical research, and an extensive reference section provides additional resourcesfor the most up-to-date literature on the topic.
Design, Execution, and Management of Medical Device ClinicalTrials is an excellent book for clinical research or epidemiologycourses at the upper-undergraduate and graduate levels. It is alsoan indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field ofclinical research who would like to better understand clinicalresearch practices.
Clinical research continues to be one of the most vitalcomponents of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trialsprovides a uniform methodology for conducting and managing clinicaltrials. Written in a style that is accessible to readers fromdiverse educational and professional backgrounds, this bookprovides an in-depth and broad overview for successfully performingclinical tasks and activities.
Throughout the book, practical examples compiled from both theauthor's and other researchers' previous clinical trial experiencesare discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and theselection of clinical sites and ending with the completion of thefinal clinical study report. Next, readers are guided through thedevelopment of important clinical documents, including informedconsent forms, case report forms, and study logs. A careful reviewof the Food and Drug Administration (FDA) and InternationalConference on Harmonisation (ICH) regulations applicable to medicaldevices is also featured. Additional coverage includes:
* Qualification and selection of investigators
* Study monitoring visits
* Definitions and reporting procedures for adverse events
* The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determinationand study endpoints
* The roles and responsibilities of all members of a clinicalresearch team
The book concludes with an insightful discussion of specialethical conduct for human research and challenging issues toconsider during the design of clinical studies. A glossary listsimportant clinical and statistical terms used in clinical research, and an extensive reference section provides additional resourcesfor the most up-to-date literature on the topic.
Design, Execution, and Management of Medical Device ClinicalTrials is an excellent book for clinical research or epidemiologycourses at the upper-undergraduate and graduate levels. It is alsoan indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field ofclinical research who would like to better understand clinicalresearch practices.
