2015Weeknotes

Guiding Principles for a CRO

The CEO of the Columbus Regional Research Institute (CRRI), Dr. Jeff Kingsley, literally and figuratively opened the doors of his organization to our team. Six of us were able to spend the day there, and we were shown many aspects of running clinical trials that went well beyond what we had learned from textbooks and other literature. The team is currently analyzing our observations in the context of our evolving map of the clinical trials system. Here, I would like to briefly note a few of my most memorable impressions.

During our first formal meeting, Jeff explained his vision of the future of medical practice, in which physicians and patients would have vast opportunities to participate in high quality research for the betterment of the human condition. In the course of the site visit, we were able to see some of the ways in which CRRI was configured to provide these opportunities.

Within the buzzing work environment, I sensed a strong feeling of teamwork. And when our team members spread out to interview individuals at all levels of CRRI, we found that everyone we talked with had a clear understanding of their roles and the importance of their roles in fulfilling their common mission.

We also learned about their group meetings, where comments and feedback were sought from every person, and where the CEO would use many of the team’s ideas in the development and operations of the organization.

I was impressed by the attention to detail, not only in matters of clinical research, but also in many other aspects as well. For instance, some of the patient monitoring procedures would require extended periods of time. Jeff, in the photo below, explained how he set up the monitoring room with extra-comfortable seats to better accommodate the patients.

I was also impressed by the organization’s outreach, not only to patients in their enrollment efforts, but, more notably, towards physicians. These were not physicians in academic institutions who can turn towards their internal research units for support, but physicians in community hospitals and clinics. There was an emphasis on local physicians and local patients, which makes sense in many ways, particularly in developing community trust and in increasing efficiencies. Below, is the Senior Director of the Emergency and Trauma Center at the Midtown Medical Center, who describes her experiences in participating in acute care medical research. This is one of the most difficult types of clinical trials to run, and, by that time of the site visit, I was not surprised to hear that CRRI staff are on call to provide support.

Speaking of efficiencies, we were shown a very significant barrier toward achieving efficiency: the lack of standardization between the sponsors of clinical trials. I took the picture below of multiple digital input devices, each for a separate study as required by the various sponsors. I can’t even get the right keys to my car when I dash off to work, so I know I would have problems trying to work in a typical clinical research site. But the team at CRRI developed methods for device matching so that, notwithstanding the lack of industry standardization, even I would be able to keep track of what device is needed for each study.

In our own research project on the system of clinical trials, we have had several discussions on the principles in the Declaration of Helsinki. So I was naturally pleased to see this Declaration framed and prominently displayed at CRRI. And, after a moment’s reflection, I began to see how these principles are actualized within this organization.

We are currently working on a deeper analysis of our observations at CRRI. But for now, I’m ending this week note with this photo of CEO Dr. Jeff Kingsley, two members of his leadership team, Felicia Irvin and Christine Senn, and our visiting team members. It truly was a wonderful day at the Columbus Regional Research Institute.

By:
Tak Igusa