Global clinical trials are a vital part of the drug development process. But when it comes to clinical trial patient recruitment, a standardized global approach fails to consider factors such as differing cultures, healthcare systems and patient needs. Instead, success hinges on local strategies for clinical trial patient recruitment. In a recent webinar, our Site Operations Lead, Georgia Hardy, discussed why we must ‘think global but act local’ when it comes to clinical trials and patient recruitment and retention. She was joined by Nicola Yingst, former Associate Director for Patient Recruitment at Pfizer, and Barbara OrlosKaminska, one of our Clinical Enrollment Managers in Poland.
Just as treatments are becoming increasingly targeted and personalized, so too must clinical trial patient recruitment and engagement.
Involving people of different ages, ethnicity, gender, ability and socioeconomic groups enables us to understand how a treatment will affect different patient populations and informs dosage and safety recommendations. But the ability to recruit such diverse groups into clinical research does not rest on globalized networks. Instead, it is through expert knowledge of local communities.
The importance of in-country enrollment specialists
According to a poll conducted during the webinar, almost two-thirds of attendees (60%) had not heard of an in-country specialist.
At Innovative Trials, we have more than 60 in-country specialists – also known as Clinical Enrollment Managers (CEMs) – based in over 70 countries. They are our ‘boots on the ground’; each speaks the local language and understands the local culture, healthcare landscape and the challenges in recruiting people into clinical trials within their country. They provide hands-on recruitment support to local sites to overcome these hurdles and ensure clinical trials meet their recruitment deadlines.
All our CEMs have clinical research experience. They may have previously been physicians, research nurses, study coordinators or trial managers, but all have a special interest in patient recruitment.
“The purpose of their role is to alleviate the burden on sites when focusing on patient recruitment for a particular study,” explained Georgia. “The benefit of these patient recruitment specialists is, because they are based in-country, they know the local culture and, more importantly, they know the local regulatory requirements.”
Support can typically be delivered on-site or remotely, with our CEMs adapting their approach depending on the sites, their location and their individual needs.
“[They] will contact the sites and work with them to build a site-specific [patient recruitment] plan,” Georgia continued. “This might be strategies that are appropriate to the site and their location, but they’ll [also] work to foresee any potential recruitment barriers…putting in place mitigation plans to stop these barriers and, in turn, increase enrollment.
“Another positive of these in-country patient recruitment specialists is that they maintain site engagement throughout the study, so keeping a particular study at the forefront of their mind and…to keep the momentum of recruitment going.”
How our CEMs consistently support sites to accelerate clinical trial patient recruitment.
Accelerating clinical trial patient recruitment through in-country specialist support
For the purpose of the webinar, a large, global study was highlighted as an example of the difference in-country specialists like our CEMs can make to clinical trial patient recruitment.
The trial in question was a randomized Phase IIb study investigating a potential treatment for moderate to severe ulcerative colitis. It involved 245 adults worldwide and the treatment was delivered via injection.
With sites based in more than 30 countries, recruitment was challenging. At the time of our involvement, some countries were exceeding enrollment expectations while others struggled. This highlights the importance of bespoke local strategies and materials to boost recruitment rather than employing a standardized approach.
By utilizing our in-country CEMs to boost enrollment rates for this global clinical trial, recruitment was met 12 months ahead of schedule.
For Nicole, who worked on this study for Pfizer, her priorities in utilizing in-country support were to support sites to:
- Identify potential clinical trial participants who are symptomatic and in active disease
- maximize both internal and external avenues to reach patients, so networking with colleagues and others who are likely to see or speak to a patient that may be eligible for enrollment
- develop easy-to-incorporate tools, material and any other tactics to help engage with potential participants at the right time.
Nicole also explained the importance of identifying and engaging with people who “perhaps tick all the boxes, but are just not symptomatic yet,” so that, if they do become unwell, they know the study is potentially open to them.
> The first steps to boosting clinical trial recruitment
To accelerate patient recruitment for the Phase IIb study, potential barriers were first identified. These included:
- recruiting during the COVID-19 pandemic
- people were required to have an endoscopy to participate in the trial
- some sites imposed stricter eligibility criteria than others
- concerns such as having to take time off work for monitoring and site visits.
Our CEMs supported sites to build comprehensive recruitment plans, which took into consideration these challenges and a site’s own resources, networks and capacity. Where there were gaps, our CEMs were able to provide resources to ensure sites had all the tools they needed from the beginning.
“We did that very early in the game,” Nicole said. “…arming sites with the tools they need versus waiting for a rescue situation [where] they’re behind and then we’re having to scramble to find those tools.”
Engagement tactics included:
- working with advocacy groups
- ensuring the right information for patients is available in their local language and in an appropriate format
- a comprehensive kit of materials, such as brochures, flyers and study guides
- keeping participants informed from start to finish
- local outreach.
“We did ensure everything was obviously in-language, but we also took into account…any nuances within each country,” Nicole explains. “There were some pieces or some tools that [some] sites just didn’t feel were going to be helpful to them…and that was okay.”
She added, “We had very comprehensive tactics, but the biggest part of it was… communication with sites.”
“[Innovative Trials’ CEMs] were able to help us be that line of sight with sites, to communicate and escalate any issues and even positive aspects, but we were able to have this reality great communication network that helped us in the success overall.”
Need help accelerating your clinical trial patient recruitment? Contact us about how our boots-on-the-ground approach promotes positive outcomes for patient recruitment and retention
Read our second blog post in this two-part series to understand how our in-country CEMs boosted local recruitment and directly contributed to this Phase IIb clinical trial meeting its recruitment target 12 months ahead of schedule.