The medical research industry changes constantly, and so do the strategies for recruiting patients. Tom Ruane is the Global Head of Patient Recruitment at Parexel.
Tom shared his insights on the latest trends for patient recruitment in clinical trials. He also discussed what constitutes effective outreach and how to keep patients at the forefront of your mind when you are designing and recruiting studies. For more information, read our interview.
Could you tell me more about your role at Parexel as Global Head of Patient Recruitment?
I have been working in clinical research for over 25 years. I traditionally began my career with data management as a clinical research assistant and project manager for CROs or pharma companies. I have a background in critical care nursing and bench science, which means that I have spent a great deal of time working with patients. Around 20 years ago, I became interested in recruiting for clinical trials. It’s the perfect combination of my desire to accelerate research with my passion for working with patients.
Does your nursing experience influence the way that you recruit patients?
It has had a huge impact. In all my roles, when I see a protocol for a clinical study, I automatically think of the perspective of the nurse or the patient. This is not a unique viewpoint since many medics work in clinical research. In clinical operations, it is all about data and processes, but patients are humans; they do not follow rules or procedures. We use an empirical approach to plan recruitment. However, there is a big gap between this approach and the reality. My experience helps me bridge this gap.
What are some of the challenges that patients face when it comes to clinical trials?
A clinical trial protocol, at its core, is a tool that allows scientists to test hypotheses. It’s all about the steps and how they impact the outcome. In my opinion, most patients are only concerned with the outcome. They’re only interested in the result if they go through a procedure or come to the clinic: Will this cure my pain? Stop my cancer? Sleeping aids? Scientists are more concerned with the process than the result. Again, there is a gap. Good clinical practice comes from good laboratory practice, but this is complex. How can this gap be closed? Education certainly plays a part. The right amount of knowledge, the correct context, and cultural understanding are critical.
What works and what doesn’t in this area? How can you keep the patient at the center of your care?
Patient insights are at the core of our service. It is a patient burden assessment that leads to a protocol analysis centered on the patient. Market research and listening to the web are used to ensure that we develop studies that will be acceptable in terms of patient burden and useful for patient treatment. Doctors and nurses are consulted, and their opinions are invaluable. Some companies even set up a series of offices to represent a clinic and invite patients to try out simulations. This adds complexity and cost, but it also fosters a patient-centric approach.
Another thing about patient-centricity. Every year, the industry adopts a new trend in patient recruitment as if it were the holy grail for solving recruitment problems. It’s encouraging to see that all stakeholders are taking note of the patient-centricity. Each person has their interpretation of this, but it’s actually not a bad idea. We’re all sitting back, saying, “What about the patient?” but we have a way to go.
Could you explain to me what your virtual waiting room concept is and why it is important?
It is a virtual waiting room for patients who are willing to participate in clinical research. If a patient says, “I would like to participate in lupus-related research,” they will be placed in a virtual room, even if no trial is available at the time. They are then ready to be contacted about another trial. This could help increase enrollment and drive medical research forward.
What is your favorite method for patient recruitment today? What do you think is changing?
You can invite patients from outside the study to participate in a trial by using various channels. If you tell a research nurse that you can bring in 40 additional calls a week, they will say, “Ugh.” They do not need any more calls; they need more eligible patients. You need to get in touch with the site and find out what they require. Also, make sure that they are set up for a greater number of patients.
In the early days, when digital outreach was just getting started, we copied and pasted inclusion/exclusion criteria. If you gather all the patients together, the majority will be disappointed if they don’t get to participate in a clinical trial. You could say that the industry ran before it could walk. We’re now more intelligent with prescreeners that can determine eligibility. And we have more targeted outreach, taking into consideration patient willingness and eligibility.