Practical Considerations for Establishing Monitoring Committees in Device Trials for Ensuring Trial Validity

• Activity Number: 121
• Type: Topic Contributed
• Date/Time: Monday, August 10, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Rajesh Nair*
• Companies: CDRH/FDA
• Keywords: data monitoring committees ; adaptive designs ; medical devices ; interim analyses ; dmc

Abstract

Adaptive designs are becoming increasingly common in medical device studies. Adaptations, if not properly implemented, can introduce bias and inflate type I error thereby compromising the validity of the study. This is especially important in device studies where randomization and blinding can be challenging. An independent data monitoring committee (DMC) or interim monitoring committee (IMC) can help ensure the validity of adaptations. Important considerations include the composition and charter of monitoring committees that are tasked with implementing adaptations. In contrast to traditional data and safety monitoring committees, due to the complexities of adaptive designs, it is important that the committee has statistical expertise to ensure that the trial adaptations are conducted as planned.