One of the most obvious differences between pharma and device studies is the presence and involvement of the device specialist or biomedical engineer or device programmer. These sponsor delegates play an exceedingly crucial role within the study and may be responsible for, amongst other things.:

  • Ensuring optimal device function
  • Responding to device deficiencies
  • Collection of study specific data
  • Relaying study-specific data to site staff and investigators

The device representative can often be the main point of contact for site staff regarding the device within a study and this person needs to be available to perform an important role as a result. The representative may be required to not only be within an operating theatre or clinical at various times of the day or night, but be present at study visits and even assist with study assessments. So many study outcomes can be heavily attributable to both the performance, relatability and communication of a device representative and this should be factored into any device study and encouraged by site staff in the view to appropriate patient care. Response to both site and participant requests may be slower as specific procedural or device expertise is required to troubleshoot participant complaints or queries so there needs to be an understanding of the exclusive requirements that are typical of many device studies.

Conversely there must be a conscientious effort made due to the unique level of direct participant involvement of what is essentially a sponsor representative to protect the integrity of the data being collected and not allow the introduction of any biases into a study that may either inhibit collection of device deficiencies or exaggerate or misrepresent any beneficial outcomes.

This also highlights an important issue for site relations as a study site as the representative may be present almost daily depending on recruitment or sample size and therefore an ability to empathise not only the participants but with study site requirements and a mutual professional respect is essential to what can be a productive collaboration that maximises both the outcomes for participants and opportunity to appreciate the processes involved in another stakeholders role in the clinical research operation.

Dom Bailey