The Evolution of Clinical Trial Recruitment

An Interview with Parexel’s Global Head of Patient Recruitment

Tom Ruane is the Global Head of Patient Recruitment at Parexel. We caught up with him to discuss the latest in clinical trial patient recruitment, and how we can ensure patient centricity is top-of-mind in designing and enrolling studies.

Can you tell me a bit about your role as the Global Head of Patient Recruitment at Parexel?

I’ve been in the industry for quite some time, working more than 25 years in clinical research. I started out the classic route - data management, clinical research associate, project management at CROs and pharma companies. My main background was bench science and critical care nursing, so I spent a lot of time with patients. About 20 years ago, I started to get interested in recruitment for trials - it’s a perfect combination of my drive to accelerate research and my interest in working with patients.

How does your experience as a nurse impact the way you approach patient recruitment?

It’s had a big impact. Through all of my various roles, whenever I have seen a clinical trial protocol, I think from the perspective of a nurse or patient - my mind automatically goes to the patient experience of a trial. It’s not necessarily a unique perspective, as a lot of medics go into clinical research. But fundamentally, in clinical operations, it’s about data and process, but the thing is that patients are human - they don’t follow rules or process. So when we plan for recruitment, we use a very empirical approach, but there’s a gap between that approach and what happens in the real world. My experience allows me to better bridge that gap.

Can you explain some of the challenges around patient centricity in clinical trials?

Fundamentally a clinical trial protocol is a scientific tool designed to test a hypothesis. Again, it’s about the steps and how those impact the outcome. But in my view, patients are mostly only interested in the outcome - if they undergo a procedure, if they come into the clinic, they’re interested in the outcome: Will it cure my pain? Stop my cancer? Help me sleep? Whatever is the endgame is most important, but it’s the process that the scientists are most focused on. So again, there’s a gap - good clinical practice is borne out of good lab practice, but it’s complex. How can we close that gap? Education is certainly a piece of it. But the right amount of information and the right context and cultural awareness is critical.

What’s working and what’s not in that area? How do you keep patients at the center?

One of the elements of the service that we offer is centered around patient insights. It’s a patient burden analysis that flows into a patient-centered protocol analysis. We use market research and web listening to make sure we’re developing studies that will be acceptable from a patient burden perspective and useful from a patient treatment perspective. We have doctors and nurses weigh in, and their opinion is invaluable. There’s also protocol simulation, where some companies will even have a suite of offices that represent a clinic - they invite patients to test simulations. It adds cost and complexity but breeds patient centricity.

One other thing on the topic of patient-centricity. In patient recruitment, there’s a new fad that the industry jumps on every year as possibly the holy grail to solving the recruitment issues. Patient centricity has been different, and it’s been it’s so heartening to see all the stakeholders sitting up and taking notice. Everyone’s got their own flavor of what that means, but actually that’s not a bad thing. Everyone is sitting back and saying “okay, what about the patient?” But we still have a long way to go.

Can you tell me a bit about your “virtual waiting room” concept and why it’s important?

The idea, essentially, is to have a waiting room of patients willing to take part in clinical research. So, if a patient says, “I’d like to be involved in lupus research,” even if there isn’t a trial match for them at that moment, they are in a virtual waiting room ready to be contacted for another trial. This could really help with increasing enrollment and driving medical research forward.

What’s your preferred method of patient recruitment these days? How do you think it’s changing?

There are a lot of options to generate a lot of referrals to a study - you can turn on various channels and invite outside patients into a trial. But if you go to a busy research nurse and say, “We can get you 40 more calls from patients a week,” they say, “ugh.” They don’t need more calls - they need more calls from eligible patients. So you need to work with the site to find out exactly what they need and make sure they’re set up to receive a larger number of patients.

As far as the evolution of patient recruitment, in the early days of digital outreach, we just cut and pasted the inclusion/exclusion criteria. But if you line up all the patients, the vast majority of patients will be disappointed by not making a trial. As an industry, you could say we ran before we could walk. Now, we’re more clever with shortened prescreeners that can help determine eligibility, and more targeted outreach that’s taking patient eligibility and willingness into account.

To learn more about how Antidote is contributing to the evolution of clinical trial recruitment, or how we might be able to accelerate your trial's enrollment, contact us.