A Data Management Perspective: How Are Device Trials Different from Drug Trials?

• 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.

• Study documents (eCCG, eCRF, etc) should be customized to ensure accurate data being collected in the database to the site staff
• Validation checks are important to make sure of quality data collection, and check understanding of site staff for key data
• DM to understand the working of the device and what components require data collection to ensure the desired outcome of data

• Ethical issue to undergo sham operation without a treatment
• Double blind trial not usually feasible with a device, but single-blind may be possible
• Choice of study methodology explained and supported by science-based evidence

Choice of efficacy endpoint important

• Input to protocol development for key data identification
• eCRF development
• Training for site personnel
• Input to blinding plan, as required

Endpoints may include imaging data or other data that requires a Data Adjudication Committee to review/agree on clinical endpoint outcomes

• Higher and moderate-risk devices should provide clinical evidence that the benefits outweigh the risks
• Updated regulations with increased rigor for EU studies, including any possible, probable, or causal SAE

• Known AEs (expectedness) associated with the device
• Severity of AE must be determined
• Relationship of AE/SAE with study procedure & device must be determined
• Specific device information, such as the device manufacturer catalogue number(s).
• Reconciliation of different components of device, including implant site/impacted body site for each component, with study site information must be done.