The many articles discussing the difference between drug and device trials are often coming from a regulatory perspective on how device trials are designed and executed. We would like to discuss how differences between drug and device trials impact data management. Good quality data is a basic foundation for assessing both drug and medical devices.
|Drug vs Device Issue||Medical Device Difference||Data Management (DM) Perspective|
|Population Studied||Selection of subjects may be more difficult in a device trial, especially for invasive procedures.
Healthy subjects not typically used for device trials, especially for implantable devices.
Inclusion/Exclusion criteria very important to select eligible study population best suited for device
Number of subjects usually smaller than drug trial
Screen failures may be a problem even if subject meets inclusion/exclusion criteria, based on subject refusal to participate, and site operational & training reasons.
|Data management activities important to provide:
|Study Design||Placebo-controlled, double blind design features common in drug trials not suitable for most device trials.
Choice of efficacy endpoint important
|Data management activities essential to identify and generate good quality data for the assessment, by providing:
Endpoints may include imaging data or other data that requires a Data Adjudication Committee to review/agree on clinical endpoint outcomes
|Safety Reporting and Regulatory Requirements||Regulatory guidelines for device safety reporting to provide data that reflect the risk profile of the device.
||Data management activities must include capture of:
A key challenge for medical device companies is to find the right expertise, whether using in-house resources, or a contract research organization (CRO) for their trial. Veranex has experience working with Medical Device companies for comprehensive services including the product design and engineering, testing, preclinical services, regulatory, and biometrics. We are here to help.