How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the tw...How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of definition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conducting clinical trial design for medical devices.展开更多
Class III medical devices are those devices that support or sustain human life or prevent impairment of human health but,when used,pose high risks to the patients.There were 15 class III medical devices that were appr...Class III medical devices are those devices that support or sustain human life or prevent impairment of human health but,when used,pose high risks to the patients.There were 15 class III medical devices that were approved by the US Food and Drug Administration from September 1,2005 to December 31,2018 for glucose monitoring and diabetes treatment.In this article,we reviewed the study design and statistical analysis in clinical trials that were conducted to provide evidences for safety and effectiveness of these medical devices.Two exemplars of clinical trials for"Eversense continuous glucose monitoring system"and"t:slim X2 Insulin Pump with Basal-IQ Technology"are discussed in details.展开更多
文摘How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of definition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conducting clinical trial design for medical devices.
基金HZ would thank the Robert H.Lurie Comprehensive Cancer Center of Northwestern University in Chicago,IL for the use of the Quantitative Data Sciences Core.The Lurie Cancer Center is supported in part by an NCI Cancer Center Support Grant#P30CA060553.
文摘Class III medical devices are those devices that support or sustain human life or prevent impairment of human health but,when used,pose high risks to the patients.There were 15 class III medical devices that were approved by the US Food and Drug Administration from September 1,2005 to December 31,2018 for glucose monitoring and diabetes treatment.In this article,we reviewed the study design and statistical analysis in clinical trials that were conducted to provide evidences for safety and effectiveness of these medical devices.Two exemplars of clinical trials for"Eversense continuous glucose monitoring system"and"t:slim X2 Insulin Pump with Basal-IQ Technology"are discussed in details.
