Linda is Director of Clinical Services at Inteliquet. She has 25+ years of nursing, clinical research, training, and leadership experience. We discussed her passion for clinical research, how she discovered it, and why she came back to it.
What drew you to healthcare?
I wanted to be a nurse since I was five years old when my grandmother was sick. I told her I would grow up and take care of her one day. When she was 80 years old, I helped with her hospice care. It was a calling, and I never wavered.
How did you get into clinical research?
I had been a nurse for years but knew nothing about clinical research; it was not part of my nursing program. During my bed-side nursing days in the hospital, you might get to care for a surgical patient enrolled in a clinical trial, but I was never exposed to medical device or pharmaceutical trials.
I was working as a nurse at a clinic for indigent adults in Toledo, Ohio. With limited resources, the clinic partnered with specialty physicians, cardiologists, orthopaedists, neurologists and others—to care for patients. A long-lost colleague came in with a vascular physician one day, and we talked about how she helped this doctor with clinical research services.
I was intrigued how clinical research could help patients with closely monitored care when they enrolled in trials. I started to work with her to screen patients for peripheral arterial disease (PAD) and other vascular disease trials. Then, I asked other specialty physicians about matching patients to clinical trials they were recruiting for. In the first year, our clinic enrolled 40-50 patients across multiple therapeutic indications—about one patient a week.
There was an interesting by-product. I was educating more patients about their PAD and other diseases plus ways to manage their overall health through exercise, diet, and stress management. This resulted in patients coming back to the clinic, regardless if they were enrolled in a clinical trial. Before we started screening for clinical trials, we had a very high no-show rate for follow-up appointments. But once we began educating patients and discussing clinical trial recruitment, 80% came back.
The vascular physician created a clinical research coordinator position, so I joined his practice; however, I continued to follow his patients at the indigent clinic. After getting a master’s degree, I worked for medical device and pharma companies directing in-house research associates, field medical device clinical specialists, nurse educators and field case managers. After a few years, I missed research and matching patients to clinical trials, so I wanted to go back to it.
What made you join Inteliquet?
I wanted to work at an innovative organization and saw how Inteliquet’s clinical trial software helped clinical research coordinators (CRCs) match cancer patients, which gave them other treatment options. It was a new and exciting opportunity to help cancer patients in the same way I had at the clinic in Toledo. The role was a good fit; with my background as a CRC, I understood the day-to-day challenges. I’ve had to learn about oncology, but nurses are adept at learning multiple therapy areas, which allowed me to continue to grow as a nurse. It’s partly why I keep nursing licenses in Ohio, Michigan, and Florida current.
So, you bridge the gap between the clinical and the technical?
Yes, the clinical and CRC background allows me to speak the same language. It also helps me to better educate and train research staff because I understand their daily challenges. It also works the other way; I relay CRC concerns about our technology and clinical insights back to the software engineers so enhancement upgrades can be made in the platform.
What are the top challenges facing clinical sites?
Clinical research staff are busy and always multitasking. There are regulatory guidelines, limited resources, and complex protocols within narrowing treatment windows. You’re screening patients and following up on study visits. You must ensure all paperwork and data collected is in order. You have to give patients ample time to talk and ask questions. You may have pills to count, blood to draw, infusions to give, side effects to capture, and patient questionnaires to hand out. You have meetings with trial monitors to make sure you’re in compliance. And of the 40-50 patients you pre-screened prior to them coming into the clinic each day, in the end, you may or may not find any eligible patients across the 8-12 trials you are responsible for. This work is not for everyone, and it is becoming more challenging and taking longer to enroll patients.
How is technology helping sites?
With technology, clinical sites can scale up their ability to screen patients. Instead of manually thumbing through charts or electronic medical records, technology allows them to work more efficiently. It also can increase annual enrollment rates, help them start new research programs, and gain a better understanding of their patient population.
Why is understanding your patient population important?
When you consider the time spent opening a new clinical trial—IRB approvals, legal reviews, contracts and budget reviews, and site initiation visits (SIVs)—you don’t want to do all of that work when you lack the patient population to support the trial.
Given the significant time and expense involved in setting up a trial, it is important to know, for example, if your site is considering participating in a triple-negative breast cancer trial with the BRCA mutation. Knowing your clinic lacks certain patients with the BRAC mutation can save much time and effort. If you are better informed about your existing patient population, you are better prepared to open the right trials. Such insight is nearly impossible when you must manually review patient charts.
Before implanting Inteliquet’s software, one site enrolled approximately 20 patients in 2018. But after implementing our software and training, they enrolled five in one month. Just as important, they turned down trials because they lacked the patient population to support them, thanks to a clear understanding of the demographics of their patients.
It may take hours to manually review 20 patient charts for study inclusion/exclusion (I/E) criteria. But in just a few minutes, using our software, you can quickly review the possible patients listed for each of your trials, allowing you to concentrate your time on a more thorough review for only those patients identified. This automated pre-screening process filters patients based on diagnosis, staging, lab values, molecular markers, previous treatment history and comorbidities against the study’s I/E. The power of the Inteliquet software is its ability to intelligently automate the process and bring a new level of clarity.
What can sites do to embrace new technology?
Don’t be afraid to embrace a new process. Everyone’s experience with technology is different so if you’re a novice, start small. We provide a custom-fit process, meeting each CRC where they are with technology, while providing a training process where they can succeed, build confidence, and master the software quickly.
What else should CRCs know about Inteliquet?
We work closely with CRCs to custom-fit their experience. We are flexible and tailor our efforts to meet your needs. We are “old school” when it comes to customer service. We assign one designated clinical engagement specialist to each account, so people know who to contact for any support, training, and questions.
We listen to our sites and take feedback to engineering for changes and enhancements. And when a site manager lets us know they are looking for a specific type of trial, we advocate for them and contact a CRO for availability. We act as a deeply engaged liaison between sites and CROs.
If you could fix one issue in healthcare, what would it be?
I want a better way to educate patients about clinical trial participation and its vital role in their care. Many patients either have misperceptions, or are not even aware of trials as a viable treatment option.
There is a lot to do to bring the right technology to improve clinical trials. We are just getting started—it’s an exciting time for Inteliquet and our industry.
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