It should be clear to pharma companies by now that there is no silver-bullet solution to trial recruitment difficulties, but Hunt says that one of the most important issues to tackle is awareness of clinical trials – which remains low among the public.
“There’s also a real misunderstanding of clinical trials in the public perception,” she adds. “Even when people do know about them, they often misunderstand what they are, what they’re for and how safe they are. They tend to base their views on sensationalised media stories, when in fact patient safety is at the forefront of the entire process.”
Even when people are aware of and understand clinical trials, pharma needs to find ways to encourage them to participate.
“That’s quite challenging,” Grace says. “We often hear from patients that they’d love to take part in research, but they just can’t find the message. Or if they find the message, the questionnaire is so complex and so restricted that they can’t actually participate.
There’s a simple solution to these problems – asking patients themselves what would make clinical trials and related communications more accessible to them. Pharma has traditionally not fully embraced this opportunity, though.
Hunt says: “I think there’s a myth out there that patient engagement methods are stale and, from a recruitment perspective, are a luxury – that if you pick the right sites you don’t need patient recruitment and engagement activity on your study. But the environment is too competitive for that to be the case.”
Luckily, the industry is making progress – Syneos Health has seen several companies starting to embrace early engagement.
Getting patient focus groups involved at an early stage of development can help pharma to home in on their target profile and develop endpoints that are more meaningful to patients.
“We’ve seen quite a few of our clients partnering more closely with patients right from the very beginning,” says Hunt, “from protocol development with key advocacy groups, to making sure that all recruitment materials are clear, helpful, have the right level of detail and answer the questions people are asking.
But Grace says that despite the “explosion” in patient engagement activities Syneos has been involved in, it can be hard to measure if more patients are actually getting involved in studies, as there are several other factors at play.
“For example, protocols are becoming a lot more restrictive,” she says. “We now understand the diversity of diseases and their biomarkers, and how they affect different populations, a lot better. This means we’re segmenting the patient population more than ever, and even if we get more people interested in clinical trials, we’re going to be looking for a much more specific group.”
Meanwhile, Hunt notes that patients themselves can sometimes find patient centricity a difficult concept to accept, as it tends to forget that the patient is a person.
“Patient centricity often focuses on the condition, which isn’t necessarily wrong, but patients want to be known for more than just their illness,” she says.
“Supporting them and their families is key when it comes to recruitment. There always needs to be a balance of scientific excellence and empathetic communications within clinical trials.
Grace says that “global consistency and local execution” is key to this.
“Even in a global trial you need to remember that different patients in different age and geographic groups require different things. For example, in a protocol with patients aged 18-65, a parent in their mid-30s is going to have totally different needs from somebody who is in their 60s and retired.
“The person in their 60s might have a more traditional relationship with their HCP and value face-to-face contact, but someone in their 30s with a child might value time flexibility, and a virtual visit over Skype might be better suited for them.
“There’s no one-size-fits-all approach for any patient population. It’s about being flexible.”
Syneos Health has gained several insights on how to adapt on a patient-by-patient basis like this by working on clinical trials in rare diseases – where populations are very small, keen to engage, and often have very specific needs.
“Something that has worked really well for us in rare diseases is patient journey mapping,” says Hunt. “This involves us looking at where patients go for information, what they’re saying, how they’re feeling, and where they go to for help.
“Other disease areas could see a benefit in doing similar exercises. It allows you to look at the unmet needs of that patient group so you can tailor how you speak to them, what kind of voice you’re using, and what channels you’re using in the messaging.
“It gives you true insight into the challenges patients face, and can ensure that you’ve got the right solutions for the right populations.”
But Grace notes that rare disease populations tend to be incredibly motivated and have a very different level of engagement to that of other patients.
“That often doesn’t translate across to other disease areas. Flying patients halfway around the world, for example, is not going to work in more common indications. On the other hand, techniques like virtual visits might be more appropriate there than they would be in rare diseases.”
There’s perhaps no easy answer to the recruitment problem, but the clear common thread is the importance of keeping the patient in mind at every step, and designing every facet of a trial with your specific population in mind. At the end of the day, trials are a collaboration with people with a disease, and pharma companies won’t get very far if they don’t understand them.
As Grace points out, “If you don’t understand your patients, you can’t be patient centric.”
Olivia Hunt leads clinical trial recruitment and communications within Syneos Health Communications UK, ranging from early phase cell therapy to phase III Alzheimer’s research. Before Syneos Health, Olivia worked within patient recruitment at Langland and the NHS. With over ten years’ experience, Olivia has extensive knowledge of advertising and public relations in both the pharmaceutical and NHS sectors.
Clare Grace brings nearly two decades of strategic global leadership expertise to her role, including a unique blend of academic, pharmaceutical, biotech and CRO industry experience. She joined Syneos Health from PPD where she held several senior leadership roles, including most recently senior director and head of global site intelligence. Clare holds a PhD in Molecular Oncology from the University of Manchester Institute of Science and Technology and a bachelor’s degree in applied biochemistry from Liverpool John Moores University.
Syneos Health is the only fully integrated biopharmaceutical solutions organisation. The company, including a contract research organisation (CRO) and contract commercial organisation (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – it brings together approximately 24,000 clinical and commercial minds to help its biopharmaceutical customers shorten the distance from lab to life. Learn more at syneoshealth.com