I am fortunate to have the opportunity to travel to multiple site initiation visits and trainings for clinical research studies each year. Meeting with the incredibly dedicated study teams is an invaluable experience as I am able to hear from the people who support the front line of clinical research.
During a recent training, I sat down with a research coordinator who seemed to be stretched very thin. Noticing this, we took a step back to talk through her hesitations. She told me that she was supporting multiple studies, all with different technologies (I was happy to hear that many included an mHealth component!). In addition to keeping track of each protocol, she needed to learn new technologies, remember multiple log-ins, and be able to quickly run through all the to-dos during a patient visit. The typical investigative site is working with 12 different systems to collect clinical research data and electronic-patient reported outcomes systems have some of the lowest ratings for quality, ease-of-use and reliability ratings (1). Finally, she told me that many times, SIVs did not allocate enough time bringing the team up to speed on the new tools they need to learn.
For those of who work in and around the pharmaceutical industry, hardly a day goes by without a discussion of patient-centricity. At Koneksa, where our technology often reaches the very first patients who test new therapies, we continue to ask ourselves, “How can we help design trials and collect data with the maximum consideration for the people who volunteer to take part in clinical trials?” This is, of course, of the utmost importance; patients are paramount to what we do and should be considered throughout all parts of trial design.
However, recently I have come to realize that an often-overlooked stakeholder is the clinical research coordinator. Research coordinators and the larger team of technicians, nurses and support staff serve on the front lines: engaging with patients, ensuring safe and ethical practices, and enabling the collection of important research data. Training and preparing these teams on the protocol and operating procedures is a crucial part of enabling them to address the range of potential challenges that may arise during a study.
With this in mind, I am often surprised at how little agenda time in study planning meetings is devoted to the topic of getting coordinators trained and prepared. The concept of site-burden is often discussed, but not necessarily at the level of the detail required to evaluate the full impact research teams. Site initiation visits and site trainings are chronologically the last item to worry about so at times, some important issues can easily slip through the cracks.
At Koneksa, we are challenging traditional assumptions about how participants can contribute their data in clinical research. While doing so, we focus on designing materials and processes that enable sponsors to design patient-centric studies, while also preparing site teams to be able to successfully do their jobs. Staring with our first study at MGH that integrated data from actigraphy devices and collected electronic patient reported outcomes data, we worked side by side with the study team to build out a tool that met their needs. Our weekly meetings with the team enabled us to collect feedback, an invaluable product development experience that laid a foundation for the tool that is used by coordinators today.
In order for Koneksa, and our client partners, to be successful the technologies we deploy in studies must be well-received, seamlessly used, and deeply understood. We believe it is critical to involve our clinical research coordinators from the start and invest in developing materials to ensure our partners have all the resources they need at their disposal.
By Matt Cantor, VP of Business Operations at Koneksa Health