HQ SME Christina Fawcett Editorial Article Headshot v1r1

Our industry is often resistant to change. Even though the world doesn’t look the same today as it did even five years ago, our industry still does things the way they were done 30 years ago. It’s time to look past what we've always done and adjust. If we don’t, we’ll be left behind.

I believe that the key to change in the CRO industry is investing in and leveraging data and technology. I’ve seen this change happen firsthand.

Centennial X1

In 2001, I landed a job in the CRO industry. I worked in the periapproval group of a large CRO. “Periapproval” means around the time of approval—whether it's pre-approval (you've done all your pivotal trials or phase III studies, and you've already submitted for approval) or you're looking for a label change or new indication.

When I started in the industry, the periapproval space experienced a shift in focus related to safety data in a real world setting. There was press surrounding new, unexpected drug safety events that occurred after drug approvals. Regulators were urging sponsors to do more post-approval research on approved drugs.

Clinical trials are well-controlled, with a specific set of entry criteria and close patient monitoring. When new medications are available to the general population, where patients look and act differently, you start to see things you didn’t expect in your research studies. This led the FDA to drive more initiatives towards Phase IV or “real world” research studies like registries. I jumped into the industry when these trends started to gain steam.

Over time, while working at this CRO, the amount of business we received was less and less periapproval. It started to shift heavier in the clinical trial/registrational space. I was assigned to more and more phase II/III research studies, but that wasn’t where my passion lied.

After doing that for a few years, I felt that my day-to-day work started to look the same. I worked on heart failure studies. I worked on diabetes studies. I worked on asthma studies. Every single study, although they had different nuances related to that therapeutic area, all struggled with the same challenges:

How do you get sites activated quickly?

How do you get patients recruited quickly?

How do you get data monitored and cleaned quickly?

The scientific question is always the same for them. They’re always trying to find out what medication is better than the current medication. In order to do that, they design a study that looks similar to all the others.

It was a constant dance between timelines and study design. You tend to implement the same mitigation strategy when you have studies with recruitment challenges. You advertise and create flyers, brochures, and referral letters, but recruitment is left to the site’s capabilities. It felt like Groundhog Day for me! I was always doing the same thing and my day-to-day work never changed.

For so many years, we’ve focused all of our time trying to bring patients to the research. Decentralized trials flip that mindset—the research is brought to the patients.

Love run
PRA HH

I left that first CRO to work within PRA’s Real World Solutions group. When I interviewed here, I finally felt like people were speaking my language. PRA doesn’t hold the “one size fits all” mentality when it comes to trials. At PRA, we figure out ways to troubleshoot what scientific questions we're trying to answer. We help design studies that get that question answered in a lower cost, high efficiency, low burden manner. This opportunity to think differently was appealing to me.

Sponsors often want all possible research questions answered at once. Studies are designed with loads of objectives and endpoints, and very strict eligibility criteria. What actually ends up happening is that the objectives are so extensive that it’s hard to answer anything with scientific proof.

A great example of troubleshooting a scientific question is PRA’s involvement in decentralized trials.

For so many years, we’ve focused all of our time trying to bring patients to the research. Decentralized trials flip that mindset—the research is brought to the patients.

Patient-centric research gives patients the opportunity to “opt-in” and be part of their clinical decision-making on the front end, instead of us always chasing them down. We're able cast a wider net, which expands our user profile and opens up research opportunities to a more diverse patient population. On top of that, we gain a robust clinical perspective of the patient. By using medical insurance claims data (prescription pharmacy claims, and hospital claims) to follow patients longitudinally throughout the course of their participation, we no longer have to rely on sites to data enter everything directly from source (the patient, a wearable, or directly from their insurance claims). Sites are then able to focus their time on high value activities, such as patient care, versus low value activities such as data entry and transcription. This gives us a better view of the patient’s healthcare over time.

It’s also important to look at the generational changes happening with our patients, ensuring that we're designing research that aligns with their values and overall healthcare journey.

Previously, we’d recruit patients while they are sitting in a doctor's office. Maybe we’d run a few ads on the TV or radio. Now, we're doing social listening through social media platforms. We can actually digitally identify where patients or caregivers are looking for research opportunities in a specific location for specific disease states. We are partnering with advocacy groups. PRA aims to keep up with how people’s daily lives are changing. We’re using all possible resources that currently exist to pull it into the research agenda.

Two weeks into the pandemic, everyone wanted to do decentralized research, but PRA was already doing it.

Decentralized trials make a great case for handling disaster situations, such as the current pandemic, in the future. We were already positioning ourselves for decentralized trial innovation months before the pandemic hit and things started to shut down. Two weeks into the pandemic, everyone wanted to do decentralized research, but PRA was already doing it.

By spending months preparing and troubleshooting decentralized trial scenarios, we've seen what works and what doesn't. We’ve gained unmatched insight and experience. Many companies experienced this shift for the first time due to COVID-19, so it was extremely impactful to their drug development process and internal operations.

If the future of research moves to be more decentralized, PRA is best positioned for this shift. COVID-19 has accelerated changes in drug development as a whole. Sponsors have been forced to find solutions on how to do more research using a fully decentralized or hybrid manner, whether using digital tools such as sensors/wearables, telemedicine/telehealth, eConsent, Home Health services or direct-to-patient IP shipments. There’s finally a shift in the industry and I hope it lasts.

Kids
Eagles

It was thrilling for me to see that PRA leadership invest in technology and tools that allowed us to stay on the cutting edge of this industry and make study management easier and more effective.

It’s challenging to change mindsets in this industry. My previous company was somewhat risk-averse at the time I worked there. Innovation was not often considered. It was thrilling for me to see that PRA leadership invest in technology and tools that allowed us to stay on the cutting edge of this industry and make study management easier and more effective.

We've invested in companies that will make us more relevant, such as the acquisition of Symphony Health, our Mobile Health Platform, and Care Innovations. Every investment is a risk—you have no idea how things might turn out. It’s challenging to integrate new companies into your day-to-day operations. It takes time to build that out before you see the return on your investment.

Our leadership pulled ahead of the curve by taking risks and estimating where research was headed. Now, we're able to build out our decentralized clinical trial research expertise for sponsors, offering countless opportunities for the future of research.


Christina is the Senior Director of Real World Solutions, Digital Health at PRA Health Sciences. Through her work on high-profile trials like the CHIEF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status) decentralized heart failure study, Christina knows when to take risks and get ahead of the curve. She was drawn to late-phase work because of its real-world challenges and the work always feels new and relevant. She has helped build virtual/decentralized clinical research options for sponsors, in turn creating opportunities for future research.

Curious to learn more about our capabilities?

Read more

Explore related content and topics