At FCE Source, we are often asked the question: “what does a Field Clinical Engineer do?” Many within the medical device industry are still learning the value of adding FCEs to a trial. In discussions with potential clients (who later hired us) we’ve been told “we think...

Successful clinical trials balance scientific rigor with ease of executability. Trials designed with the best intentions of collecting as much evidence as possible are often (ironically) the ones generating the least useful data because they are too difficult to execute. Clinical trial design must take into account the time and effort required from subjects (patients), coordinators, and investigators. Protocols achieve this through what we refer to as Design for Executability (DFE).

The transition of a clinical study from a written document into real-world medical research carried out by separate yet synchronized teams of Investigators and Coordinators across the country is an incredible feat. The training required for each clinical site is immense, as Investigators and Coordinators learn the novel technology as well as the specifics of screening, enrollment, and data management. To effectively implement a clinical study, sponsor companies should provide Investigators and Coordinators with study aids and tools as supplementary resources to the protocol.

Clinical sites that are highly engaged contribute more to clinical studies. This means higher enrollment, fewer deviations and queries, and a better relationship between the investigational technology and the end-users. So how does a sponsor company support sites to facilitate high levels of engagement? The answer is two-fold: (1) by cultivating strong relationships, and (2) by ensuring that the study protocol has been designed for executability (DFE).

Clinical trials commonly run behind schedule, with sub-optimal site selection being one of the main culprits. Sponsor companies often become too focused on “brand name” centers and investigators, and lose sight of what actually gets a study across the finish line. The best way to prevent this is through building a balanced portfolio of clinical trial sites based on qualities vital to your trial. This article outlines our recommended process for narrowing down and selecting sites.

In this article we discuss what not to do when working with sites, to ensure your trial has a smooth execution. The “Sponsor Trap” describes the mindset that sites work for you and your study, rather than recognizing that you and your study are competing for sites’ time and attention alongside many other studies. Don’t fall into the Sponsor Trap.