Central to the Mission

Harpreet Gill
Vice president of
real world solutions
Project management
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If the past few years have taught her anything, Harpreet Gill says that there is a need for the life sciences industry to think about different ways to engage with patients in clinical trials. While the COVID-19 pandemic definitely played a significant role in this, it just accelerated a need that already existed. A significant cause of this change, according to Gill, is the increased efficiency in which data can be collected.

Gill has just recently been appointed to the role of vice president of real-world solutions - project management at ICON plc, one of the world’s largest contract research organizations (CROs). Her career spans more than 20 years, and prior to this new role, she led ICON’s focus on the implementation and delivery of decentralized clinical trials (DCTs). For Gill, this is an important issue, as improving the ways that trials are performed helps bring more treatments to a wider variety of patients.

“One of the things that we are seeing is that there are more clinical trials, but there aren’t as many patients that are interested in being involved because it can be difficult to participate,” says Gill during a conversation with Pharmaceutical Executive. “We do need more patients, but we also need greater diversity as well. All of those factors are now really driving the importance of a patient-centric approach in the clinical trial setting. But also, if you take a look at healthcare and wellbeing generally, we are relying more and more on digital tools. Folks are more interested in taking care of their own health and managing their own care. We need to take a look at how we can use, manifest, and surface that interest in a clinical trial setting as well.”

JUMPING OVER HURDLES

When it comes to implementing DCTs, Gill explains that there are several hurdles the industry has to overcome. One of the main hurdles has been making sure that everyone across the healthcare and drug development enterprise has a good understanding of what exactly the term decentralized clinical trial means.

“There are a lot of definitions out there,” she says. “Some people think it’s telehealth, some people would say it’s eConsent, and others think it’s about carrying out one or more of the assessments that would normally happen at an investigator site in a local clinic or at home. So, making sure that people have a common understanding of what is meant by decentralized approaches is an important step in the adoption of novel technologies and methods. Ongoing education through discussion and consultation with sites, patients, sponsor, and regulators is central to industry progress in this area.”

There can also be challenges implementing new technologies around DCTs. Hence, a big focus in the adoption and application of these tools is a robust operational design and strong testing and validation procedures. Investing in pilot studies and engaging earlier with clinical investigators and patient advocacy groups, for example, can inform the process and help confirm the validity of the approach.

“You need expertise, and there’s not been a huge amount of expertise in the past,” Gill tells Pharm Exec. “That is changing, but it’s a work in progress. It’s not something that you can answer immediately when you’re using a completely different technology. It’s important to think about investing in pilots and engaging earlier with doctors, people, and sponsors that are willing to give things a go early on before you’ve got everything proofed out.”

Also important is ensuring that considerations are made for how sites view DCTs.

“Our experience is that they are interested but concerned about how this will work, not just in terms of the day-to-day management of the clinical trial,” says Gill. “What does that mean in terms of their responsibilities and accountabilities? It’s a business for many sites, so how does this affect their business model? These are some of the things that we’re trying to address.”

Sites also have concerns with taking part in DCTs. Gill’s experience is that they are interested and willing but need clarity on responsibilities, accountabilities, and the level of support they can expect for the technologies used in data reporting, collection, etc.

For these types of digitally-driven trials to work, Gill stresses that good communication with sites is critical, and that sponsors engage early with investigators to address their questions.

“We need to ensure that the sponsors are fully engaged, and work closely with investigators and [key opinion leaders] at the outset of the study, reminding them that this is going to be a DCT or a hybrid study and that there will be novel technologies used,” she says. “This should involve gauging their expectations, enrolling them into the process, and getting an understanding of their concerns. It also includes making sure that when we look at the site contract, we ensure that they are going to be properly reimbursed for what they need to do, as far as the trial is concerned.”

At ICON, specifically, Gill says the CRO offers direct support for sites throughout the duration of a study, providing training and a concierge support team that can engage with the site to ensure it understands the technology.

“In this way, if they’ve got questions around the technology, they can be assured of robust knowledgeable support,” adds Gill. “We think of this as almost an extension of the study coordinator.”

CAPTURING DATA

When asked how she found herself focused on DCTs, Gill says she was interested in how the clinical trials landscape changed during the pandemic and how that accelerated research; so when she was approached by ICON to lead its DCT strategy, she was keen to capture the COVID-driven momentum. Gill had witnessed how certain new technologies were being used to capture data directly from patients and understood that a patient-centric approach could be facilitated by DCT technology and methods. Devices such as the Fitbit and the Apple Watch, and other similar trackers used to track fitness goals, could be used to capture clinical data.

Using this as a jumping-off point, Gill realized that technology had gotten to a point where much more data could be collected than ever before. The best part is that this data can be collected without forcing potential trial participants to travel to specific locations. Instead, these devices allow participants to digitally record and send data, making it possible for studies to include more widely dispersed participants representing different demographics, as opposed to focusing on a specific location close to a clinical trial site. This means that studies can be populated with a selection of patients that truly represents the targeted patient population.

“Traditionally, we would get the data through electronic data capture (EDC) at the site, and way back when there was paper, we would use double-data entry,” explains Gill. “As we move to a decentralized setting, much more of that data is entered directly through digital capture and directed by the patient or a caregiver to the trial. How the data is captured is a little bit different now, and some of the advantage, particularly when it comes from the patient or from a digital health technology such as a wearable or a sensor, is that it’s a direct data source. It’s not secondary data and, therefore, you are going to get more accurate data straight into the system. Those are some of the things that we must deal with, but there are some challenges with that as well.”

One of those challenges, she notes, is the volume of data that these technologies collect can become overwhelming. While it’s good to have plenty of data, Gill stresses that it’s important that the necessary data is applied to make sure that the study provides the most accurate results to answer the research questions specific to the trial protocol.

THE PATIENT EXPERIENCE

One thing that’s clear from Gill’s discussion about DCTs is that while they have a lot of benefits, this approach also comes with a significant number of challenges. For Gill, these realities are familiar territory, having spent her career working on clinical trials and searching for ways to improve them or make them run more efficiently.

“I spent my early career in clinical trials working in the project management office, and that’s really where I cut my teeth in understanding what clinical trials were about,” she says. “As I moved on, I ended up doing oversight for a very large study in atrial fibrillation (AF). It was a global study with 55,000 patients. It was huge. One of the most inspirational parts of that was seeing how the analysis of that data was then actually used to improve the lives of patients. For example, based on the data analysis, the sponsor developed a new risk score that clinicians could use to more accurately predict outcomes for AF patients, allowing the clinician to make adjustments in the patients’ ongoing care to improve outcomes.”

Based on this experience, Gill learned the importance of quality data and the ways that data can be used to provide evidence to improve patient care. Such realizations can be very motivating. “That was a wonderful moment,” she says, referring to the AF study, “to acknowledge being involved in something so significant. It’s moments like that when you see something come to market that you’ve worked on and you see something being approved by the FDA.”

The patient experience has long been a motivating factor and driving force in Gill’s career. “Many of us have family members that live with a long-term illness,” she says. “My mother had diabetes, so from when she was first diagnosed and had to use a syringe, I see how things have moved on to using the pens and other devices. And later in life, seeing friends of mine whose kids have type 1 diabetes being able to use devices to continuously monitor their blood sugar and, therefore, have a better quality of life. It’s just so important and it’s the thing that really engages me in the industry today.”

When asked what led Gill into the life sciences industry, she gives a surprising answer. While noting again the motivation from watching her mother battle diabetes, she says that where her career path has landed her today wasn’t necessarily the plan from the beginning.

“It was probably by accident rather than by design, but once I arrived in the life sciences industry, it felt like home. It felt like this is where I should be and this is what I should be doing. I think you’ll hear that from a lot of people in this industry,” says Gill, who, before joining ICON in 2022, spent 21 years with the CRO giant Quintiles and later IQVIA, the result of Quintiles’ merger with IMS Health, Inc. “It’s knowing that you’re part of something that really does give back to society and to patients. That is a real motivator. I feel that we really do improve the quality of life for patients.”

Reflecting back, Gill says the best and simplest advice she would give to young professionals entering the industry today is that they should focus on what they’re really interested in. If they’re motivated by the science, that’s where they should focus their energy. However, as she points out, others may be more motivated by the management side of the industry, where they can focus on areas such as strategy.

Gill mentions that her ultimate goal is to help patients. She now brings that mission with her to her new position in real-world solutions, where she will be exploring how real-world data can be used to support product development, and the hope of harnessing that data to transform what motivates Gill the most—the patient experience.