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 IssueMedical Device DifferenceData 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 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
Study Design Placebo-controlled, double blind design features common in drug trials not suitable for most device trials.
  • 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
Data management activities essential to identify and generate good quality data for the assessment, by providing:
  • 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
Safety Reporting and Regulatory Requirements Regulatory guidelines for device safety reporting to provide data that reflect the risk profile of the device.
  • 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
Data management activities must include capture of:
  • 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.

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.  Click here to contact us.  We are here to help.

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