The People Behind the Products: Madeline Naylor

I'm our Chief Clinician at Citeline. I come from the perspective as an RWD [real-world data] expert and clinical expert when assessing our projects. I have my doctorate degree and worked in clinical research directly with patients for 10 years before moving into the Citeline world.

Since I’ve been here, I have primarily focused my efforts on building the RWD asset. That meant bringing in the data sources, integrating the data, and now working to ensure we translate that clinically for our clients. You could say I came back to my roots in clinical, determining how we can best support our clients with the foundational data we have built.

I started in clinical research about 15 years ago as a research coordinator out of college as I was working through my graduate degrees. First, I earned my master's in medical science, conducting on-the-ground research, specializing mostly in neurology, but also spent time in dermatology and cardiology. Before moving into Citeline, I was conducting surgical trials, scrubbing into patient surgeries every day, which was really interesting. You really can't get more hands-on than heart surgery. When I finished my doctorate degree, I continued in patient clinic work as the PI [principal investigator] of trials.

By leading and developing trials, I then moved into my role at Citeline in 2020 as the Director of Clinical Research and later Vice President of Health Informatics, RWD. While I was using more of the data-driven insights, I also utilized what I learned in clinics and direct patient care for all those years.

Last year I was named Chief Clinician; I oversee our Citeline teams and all our clinical data.

Esophageal cancer was a particularly difficult journey because it is often diagnosed so late; patients don't typically have symptoms in early stages of the disease. My dad's first symptom was difficulty swallowing, and by that time it was because the tumor had grown so large. Other than that, he was healthy, he was athletic, he was playing sports and going to the gym. So, our world got completely turned upside down in a 24-hour time period. We never thought the diagnosis was going to be a late-stage cancer. All cancers present challenges, but this one was a particularly rough path to go down.

I would say the biggest advice for patients and caregivers is to advocate. Physicians are very good at what they're doing in their day-to-day. But one of the things we really value at Citeline is trial awareness. Physicians are often very keen to go standard-of-care routes. It's because that’s what they know. What they don't always know are all the trial options out there. So, unless you're a PI actually working in the trial, those options aren't always presented to the patient. Sometimes it's the patient or the caregiver presenting those options.

Make sure you advocate for your care; make sure you advocate for your loved ones’ care. It’s important to have the relationship with your doctor where you can talk through the different options.

Our goal at Citeline is to educate physicians of trials available and make them comfortable to refer their patient if it's a fit.

As the caregiver, we were never presented trial options with my dad. I was trying to do my own research. It's amazing that someone could be in the healthcare field and be so integrated in clinical research every day, and still feel a little lost when it comes to the world of trials for your own loved one. And that's what at Citeline we're trying to navigate. We're trying to bridge that gap, making it very easy for both patients and physicians.

My days really vary. There are days where I'm in calls and meetings, working with our clients, hearing what their needs are, listening to how we can support them, and then scoping solutions based on those needs. Not having direct patient interaction anymore, it's nice to work with clients. I like knowing what they’re doing to make an impact.

I am also spending my days on internal calls collaborating with my team. You know, working remotely is nice, but you're not in a room whiteboarding with your colleagues. You're collaborating on these complex situations and doing it in a remote setting.

And then some days I'm just in the data. I'm in our Citeline proprietary data, like Sitetrove and Trialtrove, and in our RWD. I spend a lot of time in our real-world data assets, especially diving into all our EMR data.  We have billions of de-identified clinical notes in our system; with access to over 600 note types in our unstructured data. It's essentially me going into patients’ charts, without knowing any PHI [protected health information] and reviewing all those clinical dictations, reading their clinical interactions and finding the points of clinical attributes to match them with an appropriate trial. On these days, I am doing data analysis, algorithm building, and working in our data to build our solutions.

We certainly do use NLP [natural language processing] and large language models [LLMs] for our use cases. The clinical team still lays eyes on the data that's going into the large language models and NLP.

Everything we do, we call it human in the loop, and that's why we built out this clinical team very specifically. We want to ensure what's going in is clinically accurate and then what's coming out is clinically accurate. The AI models help us process this data quickly and efficiently. There's still a lot of manual pieces that we're doing just to ensure we're not losing that accuracy. We build the algorithm, which is what is fed into the AI model, so there are still a lot of clinical notes we read. The AI model does its job and then there's that clinical QC [quality control] to make sure the AI model is working. We couldn’t do our jobs effectively without our AI models, and we have had great success with our models, making it a close collaboration between teams to make sure the process runs smoothly and accurately.

Knowing that we're making an impact. I don't get to see it anymore directly. I used to work with patients all day long. We could see how the patients are doing, how they're progressing.

Now, everything's de-identified on our end. So, I don't get to see that anymore, but I get to hear from our clients:  “Your data made a difference.” One of our clients told us working with our team was the most impactful project that they have ever been a part of. And it was a large client working in this space, a very large pharmaceutical company, reaching thousands of patients.

I get to make such a greater impact across indications, touching a larger number of patients and families with all the data we have access to and all the solutions we can offer our clients.

The medical field in general is always changing. Six years ago, when I started here, we didn't have any RWD, and now we have the entire RWD data asset with 74 billion data points, which is amazing. It's learning how to effectively translate that and make sure our clients can use it effectively.

You also never heard the terms AI or NLP models six years ago when I started here. Now everything is around how we're utilizing AI and how we're improving efficiencies. I think Citeline's ahead in a lot of areas, continuing to evolve with the industry. We do this by listening to our clients’ feedback and offering the best solutions for them.

We're really diving into patient engagement and recruitment offerings for our clients. We’re continually working on how we can utilize our Citeline PatientMatch solution in the most effective manner, helping accelerate those recruitment and enrollment goals for clients. So that is a key focus.

We also are bringing to the market a new patient journey offering. This allows our clients to see the end-to-end clinical journey for patients: how they're presenting, when they're presenting, who's caring for that patient. We’re also spending a lot of time and effort on feasibility as a service.

Clients come to us at different points in their enrollment. Some trials are in protocol development, some are finding sites and assessing feasibility, some are ready to start enrollment. Our goal at Citeline is to be able to support throughout study creation and implementation, no matter where they are in their development. So, we're adding efforts on how we can support earlier, integrating our real-world data with our Citeline data.

Clinical trials today are complex and growing in complexity every day. This leads to screen fails for patients for a lot of patients because of all the criteria they have to meet, and site burden for site staff presenting challenges for their enrollment goals and timelines.

We're hoping we see accelerated enrollment in clinical trials. Faster enrollment means bringing more drugs to market faster. Trials have the potential to be life-changing for patients and their families.

I have a 6-year-old at home who is my world. His name is Stephen, named after my dad. He keeps us on our toes, so my days outside of work are always an adventure. Our weekends are filled going to different sporting events or going to some sort of family activity. It’s also nice to have down days at home together; we are very mindful of spending time together as a family.

I’m just grateful for the opportunity to be in this company and work with such a magnificent team. I think we're made up of a bunch of great individuals and I’m looking forward to what we're going to do next.