Influenza (flu) vaccines are a staple part of keeping people well during the winter months. As the nights get darker and flu season across the Northern Hemisphere intensifies, many depend on an annual vaccine to prevent them from getting seriously ill. Equally, those who get sick with flu benefit from treatments such as antiviral drugs to lessen symptoms and accelerate recovery. Of course, the development of all treatments, including vaccines, is dependent on people taking part in clinical trials but this can be challenging for influenza studies, especially given the typically short patient recruitment window. Some flu studies may require clinical trial patients to already have the illness or leave themselves open to the risk of getting it, which can reduce the number of people willing to participate. In a recent webinar, our Senior Associate Director in Patient Recruitment, Georgia Hardy, joined other industry experts to discuss key considerations for sponsors and sites to optimize clinical trial patient recruitment and retention.

Seven steps for greater clinical trial patient recruitment and retention success in flu vaccine and treatment studies

Place patient convenience at the heart of protocol design

When developing any clinical trial protocol, sponsors should consider patients’ needs and take action to prioritize convenience for clinical trial participants wherever possible. Home health visits, for example, enable patients with the flu to participate without leaving home, reducing discomfort and a barrier to entry. “Remember how it felt the last time that you had the flu and you just felt super crummy, and you just wanted to feel better?…those are people that are coming in to see you. They just want to feel better…so how can you make this the easiest thing for them to do?” – Amber McAllister, Associate Director of Patient Recruitment at Parexel Our Patient Support Center service (also known as Navigator), can also provide patient-centered support, guiding clinical trial patients through each stage of the study, from prescreening to endpoint. The team can also provide emotional support and act as a listening ear to resolve any logistic or procedural issues. Putting patient convenience and comfort at the forefront of your protocol design can help set you apart from competitors. Always try to think about how you can make things easier for patients.

Use data to inform and drive enrollment campaigns

Aligning digital recruitment campaigns with flu surveillance data enables targeted outreach to geographic areas experiencing flu surges. This can quickly increase the cost-effectiveness of clinical trial patient recruitment campaigns; by understanding when and where flu hotspots appear, sites can better reach people at the peak of need, allowing for more timely enrollment. “If I know that the cases are going to be high in London next week, I might then increase a digital campaign to go alongside that because the likelihood is that there’s going to be lots of people that are either about to contract flu or have flu, and they may be scrolling on their phone…Alongside that, I might also consider doing community outreach in those locations.” – Georgia Hardy, Innovative Trials’ Senior Associate Director in Patient Recruitment In addition to geographical locations, consider other factors that may influence flu trends. The tradition of Freshers’ Week within UK universities, for example, can often run parallel with flu spikes. Strategize accordingly to ensure population groups are reached in the right way at the right time. Employing a data-driven recruitment strategy is especially important for flu treatment trials where recruitment windows are typically short. However, for this approach to be truly effective, materials must be prepared in advance so that they are ready to distribute quickly, thereby mitigating the challenge of tight enrollment deadlines. 

Actively seek to reduce the burden on sites

Research sites are often time- and resource-limited. As a company, we regularly hear how staff can find it difficult to balance their commitments due to shifting priorities and lack of time. For efficient patient recruitment in flu studies – or any study for that matter – sponsors should look to de-burden sites as much as possible. Solutions that can streamline trial logistics, like centralized portals, allow for rapid access to information and efficient site management. Providing site staff with training that is both brief and focused on essentials can further enhance this process. “If you’re the sponsor, if you’re the CRO…think about ways to de-burden your sites. Make things easy to access…Put [information] on a portal where everything is there. Make sure that the training is fast, it’s to the point so that the patient, or, sorry, the site, can find that information when they need it, and they’re not searching through that really big protocol to try to find it.” – Amber McAllister Our 1:1 In-country Recruitment Coaching and Site Support can bolster this approach. With clinical trial patient recruitment experts based in more than 70 countries, we are ideally placed to work with sites to understand their challenges and work with them to create site-specific enrollment strategies and optimize their processes. Equally, our Patient Support Center helps to de-burden sites by taking on the responsibility of patient engagement from the referral prescreening stage through to the end of a study. 

Patient education to overcome barriers in vaccine trials

Patient education is crucial in flu vaccine studies, where the need for proactive participation must be communicated clearly. “Patient education is key…explaining about clinical trials in general, explaining how the research can, kind of, benefit future treatments…giving them that risk-benefit analysis, really breaking down, kind of, why it’s being researched, I think, is so important….having different ways to educate the patients, whether that’s a healthcare professional sitting with the patient to explain it or whether there’s those different recruitment materials, depending on how that patient likes to learn, read and absorb that information.” – Georgia Hardy Detailed educational materials, available in various formats (e.g. videos and pamphlets), should explain the trial’s purpose, the safety of the vaccine, and how participation contributes to broader public health. Tailoring this content to varying levels of health literacy will ensure all patients can make informed decisions, regardless of their prior familiarity with clinical research. For one Phase IIIa clinical trial investigating Type 2 diabetes in children, we increased prescreening rates by 181% and achieved a 20% uplift in patient recruitment rates through increased education. We worked with sites to develop information in a way that would best resonate with children and teenagers and approach schools and school nurses to disseminate it – a strategy that proved more effective than advertising in hospitals.

Create localized and accessible patient materials

To ensure inclusivity and clarity, and promote informed decision-making and consent, patient materials should be tailored to local languages, cultural preferences, and literacy levels. “Health literacy is definitely very important; making sure that the content is localized, translated in different languages, and basically, the patient…which group, minority group they are part of, they have the materials, the patient-facing materials available in their own language, so for them to make an educated decision regarding the study.” – Antonio Drea, Director of Strategic Accounts for TransPerfect Effective localization means not only translating materials but also understanding regional language nuances. By taking this approach, comprehension is increased and patient engagement is enhanced. Utilize translators and cultural consultants to optimize your materials. This will make it easier for diverse patients to access and understand trial information, thereby building trust. At Innovative Trials, we always ensure our site and patient educational materials are created in the most accessible way for the patient populations being targeted. Read how we accelerated clinical trial patient recruitment for a Phase III study into pediatric moderate to severe atopic dermatitis, which included creating a wide range of age-appropriate and inclusive educational materials.

Leverage technology to enhance engagement

Technology can help streamline recruitment and retention efforts, removing friction points for patients. Utilizing QR codes on recruitment materials, for example, especially in high-traffic areas like pharmacies or doctor’s offices, offers quick access to study information. Educational videos that clarify the purpose of the study, eligibility criteria, and what participants can expect to provide accessible information and can help address questions before enrollment, fostering confidence in the study process. “…technology plays a huge role in overall content creation and localization of patient-facing materials, as well as marketing materials, digital campaigns, creation of video content…anything at all that can help enhance the patient engagement strategy.” – Antonio Drea However, it is imperative to consider the intended audience, especially if you want to attract and enroll a diverse group of patients. Technology can make it easier to share information in a convenient and bitesize way, but some people may still prefer written information. Also, bear in mind that not everyone has access to the internet or equipment like computers, iPads or smartphones. Here at Innovative Trials, we work closely with our clients to develop bespoke clinical trial patient recruitment materials which resonate with the populations you want to target. Find out more.

Patient-centric planning and implementing a rapid response

A patient-centric approach, with proactive and two-way engagement, and a rapid response to enquiries, is essential in retaining clinical trial patients. This requires clear communication, empathetic interaction, and minimal wait times. “There’s a site in Nashville that has a 97 percent retention rate for studies and they get patients coming back again and again and again. And I asked them, like, what’s your secret? And it comes down to the simple things. These simple things about connecting with people at an empathetic level, in a language they understand, in a manner they understand, giving them the right amount of information.” – Leanne Woehlke, Executive Vice President of Soglia Utilizing a third-party patient support service, such as our Patient Support Center, can offer the rapid engagement that many sites struggle to deliver. Not only that, but with human team members at its core, patients are guaranteed to be listened to and treated with respect and empathy at all times. This type of support eases the workload on research staff, allowing them to concentrate on other aspects of the trial and patient care, and delivers the timely and empathetic responses patients need and increasingly expect. 

Innovative Trials is committed to supporting sites and sponsors to streamline site operations, accelerate clinical trial patient recruitment and enhance patient engagement. Download our toolkit to unlock more patient recruitment and retention tips for your flu studies.

Thank you to Leanne Woehlke, Executive Vice President of Soglia, a division of Entrada, for hosting the Optimizing Patient Recruitment & Retention in Influenza Studies webinar. Georgia and Leanne were joined by Amber McAllister, Associate Director of Patient Recruitment at Parexel, and Antonio Drea, Director of Strategic Accounts at TransPerfect.