Research Insights from CTNx’s Director of Site Relations
An Interview with Seth Brine
Q: How did you get involved in research?
A: I had recently graduated with a bachelor’s degree in biology and planned to take a year off before going to medical school. During the break, I found an opportunity as a Clinical Research Assistant at a local gastroenterology practice. It was an exciting position as I had a lot of autonomy right out of the gate. I was independently seeing patients, screening them for study participation, guiding them through informed consent forms, and even sitting in on colonoscopies. The biggest reward though was the impact we were making on patient’s lives.
Just as I was starting my applications for medical school, I was presented with an opportunity to join The Clinical Trials Network (CTNx) and help build their second specialty network in Ophthalmology. It was an amazing opportunity to be part of something special, so I took the leap.
Q: You mentioned it was extremely rewarding having an impact on patient’s lives. Can you elaborate?
A: One patient stands out in my memory. They participated in a study and got access to a free screening that they probably would have never had done on their own. During the study, we discovered the patient had Barrett’s esophagus, a pre-cursor to esophageal cancer. It was extremely gratifying to make this incidental finding that allowed the patient to seek treatment before the condition could escalate into something more serious.
Q: What all does the Site Relations team do for CTNx sites?
A: Our Site Relations team has two main focuses: Data Management and Site Support.
On the data management front, our Site Relations team builds the source files, handles data transcription, and helps with query resolution.
Q: Can you provide further detail on what it means to build source files, handle data transcription, and help with query resolution?
A: For data management, we use an eSource or Clinical Trial Management Software (CTMS) to build all the data fields that need to be captured and entered for each patient visit. Without this digital tool, sites would need to build the source themselves or maintain physical paper records for every patient, which is a huge organizational challenge. By handling the source build and maintaining everything digitally for our sites, we make each patient visit and the data capture near effortless.
For the data transcription, our Site Relations team takes the data that is entered into the CTMS and transcribes it into the Sponsor’s Electronic Data Capture (EDC) system. Some of the experienced research coordinators who had done their own data transcription prior to working with CTNx have said we save them one or two days a week by taking the data transcription off their plate. That’s huge as we’re giving coordinators time back that they can spend on patient care and study enrollment.
For query resolution, often Sponsors need clarification on a data point that has been entered into their EDC. 8 out of 10 times our team can answer those queries without bothering the coordinator, allowing them to stay focused on their patients.
Q: What do CTNx sites love most about working with the Site Relations team?
A: CTNx sites love our Site Support team. They love being able to have someone on speed-dial to provide support and guidance whenever they have a study protocol question. Our Site Relations team supports nearly 100 sites, so they are intimately familiar with every study protocol and are a great sounding board should a PI or Coordinator have questions.
Additionally, our Site Relations team meets bi-weekly with each site to answer study protocol questions, prepare for upcoming visits, address any issues, and provide advice.
Q: What challenges do sites face without CTNx by their side?
A: One of the biggest challenges is the sheer amount of paperwork. Everything must be properly documented, or it didn’t happen. Dealing with paperwork can be time-consuming and may lead to disorganization. We handle nearly all the paperwork, so our sites can focus on research and the patient.
Q: What impact does your team have on sites that are new to research?
A: For new research sites, getting started can be overwhelming. Our Site Relations team supports them every step of the way, ensuring they are prepared when it’s time to activate. We provide training on the research equipment, research software, CTNx’s Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and so much more.
We also coach our sites prior to their first pre-selection visit (PSV), so they know what questions to expect from the Sponsor and how best to answer them. Additionally, we visit sites in-person for major milestones such as their first screening and randomization to ensure their research staff is comfortable and fully prepared to go.
Q: What do you find most enjoyable about being CTNx’s Director of Site Relations?
A: The significant impact we make. Running successful clinical trials allows us to offer patients alternative treatments and bring these treatments to communities that may not otherwise have access to them.
Q: What advice do you have for new research sites or ones working on scaling their research program?
A: Keep an open mind when trying to land your first study. New sites sometimes pass on study opportunities because they aren’t in their primary area of focus or due to concerns about patient recruitment. However, even enrolling a few patients can make a meaningful contribution to a study. Also, once you complete your first study, you’ll have research experience, and more study opportunities are sure to follow.
Thanks Seth! We appreciate you taking the time to chat with us and share some of your valuable insights.
If you have interest in making an impact on patient’s lives and getting involved in research contact us below!
