Why is Clinical Trial Recruitment so Hard?

By: David Grew MD MPH

How conversations helped me understand the pain of clinical research stakeholders.

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Since launching PRIMR for clinical trials in June 2022, we get a lot of organic inbound from interested teams who are trying to figure out if working with us makes sense for their organization.  So in this blog we’re pulling together key insights shared by our customers (from call notes, emails, texts) about their specific pain points, what they’ve tried, why they chose PRIMR and how it’s working for them.  All the quotes are from real PRIMR customers.

What is the Pain Point?

The common thread is participant recruitment and retention.  A lot of stakeholders have aligned incentives aiming at solving this problem: motivated patients want access to cutting edge treatments, PIs have an intellectual passion for answering key clinical questions (and also career trajectory tied to successful completion of trials), and sponsors have a core mission to rapidly fill seats, gather data and move closer to getting their drug or device to market - not to mention a deep financial incentive.  One of our goals at PRIMR is to build products that delight all three of these stakeholders.

Here are some ways our customers have framed the recruitment and retention problem:

• Fear and Mistrust: “This trial is complex.  We’re worried patients won’t understand it.”  If patients don’t understand the trial question and the proposed intervention, it’s almost impossible to establish trust and go on to get informed consent.  Many PI customers come to us to help take their protocol and convert it into an easy to digest video.  By virtue of being innovative, most medical breakthroughs are complex and difficult to explain.  But before we make these treatments available to the masses, it’s critical we nail the explanation to eligible volunteer participants on clinical trials.

• Lack of Awareness: “I want you to make our trial go viral.”  Some PIs want to tap into the FOMO element of MD brains that may accelerate enrollment on a “hot” trial.  The best way to do this is of course to write a trial that will answer a key question on the mind of every day docs - they are highly motivated to get an answer, and will enroll their patients.  But even then it can be hard to stand out in a crowded field.  For them, creating videos was an attractive way to leverage a highly scalable, easily shareable asset that can be distributed with zero cost of replication - by email, on Twitter, in a slide deck at a podium presentation… however they like. Since they were not expert in creating engaging animated video content, they look to vendors for help.  

• Language and Cultural Barriers: “Given disparities in research participation, we need foreign language resources.”  Some clinical trial sites have phenomenal language services, some don’t.  When you’re opening a trial on a massive scale, there is a need to standardize high quality education in multiple languages to ensure there is equal footing for eligible participants from a variety of backgrounds.

• Staffing Shortages: “We’re losing nurses fast.”  When site staff are thin, the only way to maintain or improve clinical trial enrollment is by introducing tools to improve each team member’s output.  Some sites were looking for a way to “pre-load” education about trials ahead of consultation so patients came with foundational knowledge in place.  In our early days, we built a web app to distribute trial content to patients’ devices before a clinic visit,  But site engagement was low.  When we asked why they weren’t using it, they said they could not bear logging into yet another platform during their clinic day.  Fair! As a doc, click fatigue is one of my greatest drivers of burnout. 

What have research teams tried so far? (And what frustrated them with failed solutions)

• Paper Fliers - “There is no click through rate on a trifold flier”. Fliers, a traditional (and sometimes useful!) distribution strategy has obvious flaws in the digital age. They are often distributed in public places or clinics, but unfortunately, they frequently end up discarded in the trash without being read or considered. As a result, the recruitment message fails to reach the intended audience, leading to low engagement rates and limited participant retention. Unlike digital methods, paper fliers provide no means to objectively measure the level of engagement or gauge the success of the recruitment campaign. Without such data, it becomes challenging to assess the fliers' impact and make necessary adjustments to improve recruitment strategies. In the age targeted marketing, relying on paper fliers alone severely limits the potential reach and effectiveness of clinical trial recruitment efforts.  It is impossible to iterate off a solution with no feedback loop.

• 1:1 Interview videos - “I don’t want my face out there.” Interview style videos featuring the principal investigator (PI) are tempting because they can be low cost and relatively easy from a production standpoint (circle light and iPhone stand).  But as a participant recruitment tool for clinical trials, our customers tell us they can be flawed for a variety of reasons. First, patients often have a strong sense of trust in their local doctors, with whom they have an established relationship, but may be skeptical or biased against a PI they perceive as either a “coastal elite” or a “flyover state doctor”, depending on their own location. This lack of familiarity can hinder the recruitment process and deter potential participants. Additionally, while PIs are experts in designing trials and conducting research, they may not possess the necessary skill set for delivering an engaging on-screen performance.  This can lead to less impactful videos that fail to resonate with the target audience. Many doctors are camera shy, and totally uncomfortable with the idea of performing on camera.  Some have even acknowledged that listening to themselves talk about the trial is boring and cringey. They’re seeking an alternative solution to effectively communicate the trial's key elements and importance for advancing medical innovation. Instead they’re turning to specialist services like PRIMR to convert their protocol into an engaging scalable educational resource.

• In house marketing team - “It will take forever and the final product will be bad”.  In-house marketing teams at academic institutions, pharmaceutical companies, or Contract Research Organizations (CROs) often lack the necessary clinical expertise to create accurate and effective patient education materials. As a result, their products may require multiple revisions as they attempt to apply marketing solutions to complex clinical problems. Working with these teams also poses an opportunity risk, as their content may face resistance or scrutiny from Institutional Review Boards (IRBs), necessitating further revisions and consuming valuable time in the trial recruitment process.

• Outsourced marketing agencies - “Very expensive and ultimately unimpressive work product.”  Most marketing agencies focus on commercial content, which may not align with the specific educational needs of a clinical trial, making it less suitable for patient recruitment efforts. One person complained their agency-outsourced video for an arthritis trial closed with an image of a spry elderly couple jogging through a meadow.  Aside from the cringe factor, work product like this will get flagged by IRB for borderline coercion.  This is selling an unrealistic outcome. Aside from their obvious clinical (and ethical?) blindspots, collaborating with marketing companies can be cost-prohibitive.  Even if technically doable, the price tag can strain patient recruitment budget allocation for the clinical trial - risking the whole pot on an iffy solution. For comprehensive and tailored patient education materials that resonate with potential participants and navigate IRB requirements smoothly, most are searching for specialized teams that possess both clinical expertise and marketing acumen.

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Create - Recruit - Enroll: PRIMR’s unique approach solving these problems

After thousands of hours of conversations with real patients, PIs, sites, sponsors and CROs, we developed a comprehensive end-to-end solution for the patient education, recruitment, enrollment journey.  We are best known for our video content.  But we are not a video company.  We built a clinical trial recruitment engine, in which video content is merely a tool we use to educate and engage motivated patients and providers.  Here’s a breakdown of the process:

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Create

Our first step is to create educational assets that deeply resonate with your ideal patients, breaking down barriers to clinical trial diversity. By conducting live sessions with a board certified oncologist, we ensure that our content strategy aligns perfectly with the needs and preferences of your target patient population. These sessions help us craft custom, IRB-approved videos that effectively explain the clinical trial and highlight the benefits of enrollment (typically answering a key clinical question for future patients). Each video is brought to life by a professional medical graphics artist, ensuring clear and engaging visuals, while the content is written and narrated by oncologists for an authentic and trusted voice.

To further enhance accessibility and inclusivity, we go the extra mile to translate our trial videos, both graphics, and narration, into two additional languages. These translations are meticulously done by MDs, guaranteeing a credible and empathetic voice that resonates with patients from diverse linguistic backgrounds. By offering videos in multiple languages, we empower patients to understand critical trial information in their preferred language, facilitating a deeper connection and encouraging greater participation.

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Recruit

One of our unique features is the creation of print assets with QR codes for point-of-care distribution. These assets are customized for each trial site, allowing for site-level analytics and performance tracking. By leveraging QR codes, patients can easily access trial-related information, while trial teams can gain valuable insights into engagement levels at specific locations.  This is a low-touch/no login required method to serve patients with trial-specific education that unburdens overworked site staff.

To maximize visibility and reach, PRIMR creates custom trial pages and hosts trial videos on our website. These videos are strategically featured in the "Related Trials" section, specifically targeting patients who actively search for evergreen educational content related to their disease. Furthermore, we ensure broader exposure by distributing trial videos across various social media channels, including Twitter, Facebook, LinkedIn, Instagram, TikTok and YouTube. Additionally, our blog feature with distribution to our newsletter audience amplifies the reach and impact of the trial materials.

Data-driven insights are vital in optimizing clinical trial recruitment efforts. That's why PRIMR provides comprehensive data analytics and reporting on a monthly basis. Our reports include crucial engagement metrics, such as impressions, views, videos opened, and percentage viewed, offering a deeper understanding of participant interactions. Furthermore, our enrollment funnel conversion tracking, which covers screened, referred, and enrolled participants, provides essential information to assess and fine-tune recruitment strategies. With the ability to sort data by video, device, city, state, and country, trial teams gain valuable insights into the effectiveness of their educational content and recruitment campaigns.

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Enroll

One of our standout features is having an oncologist on-call to speak directly with patients and screen inbound referrals. This personalized approach ensures that patients receive expert guidance and support throughout the process, fostering a sense of trust and empowerment in accessing innovative treatment options.

With PRIMR's dedicated focus on providing a VIP experience for patients, we strive to make their journey seamless and informed. By offering personalized assistance and education, participants feel empowered to make informed decisions about their healthcare, including exploring clinical trial opportunities. This patient-centric approach not only benefits the individuals but also contributes to the overall success of clinical trials - we serve sites with screened, highly motivated, educated patients.  Our goal is to get the right patient to the right trial.

PRIMR's commitment to excellence in participant recruitment and enrollment directly impacts the success of clinical trials. By streamlining the recruitment process and ensuring efficient accrual, trials can reach their goals faster. Consequently, new cancer treatments have the potential to get to market more swiftly, offering hope to countless patients in need of cutting-edge therapies. 

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Bonus Value Points:

At PRIMR we’re always listening to our partners to go above and beyond and meet the evolving needs of clinical trials.

• We offer unlimited video revisions based on protocol amendments, allowing trial teams to adapt their educational content as necessary without limitations. 
• Our ongoing license grants our partners the usage rights of PRIMR's general cancer education videos on their website and in patient educational materials. With a minimum of 5 educational videos per therapeutic area, this collaboration enables our partners to bolster patient education and awareness via their own platform.

• Our commitment to re-engaging participants during key stages of a trial sets PRIMR apart. Through a 3-part, custom educational video “drip” series per trial, we aim to minimize non-compliance and reduce "loss to follow up". 
• To further optimize patient outreach, we collaborate with our partners’ clinical trial management software vendors to seamlessly integrate videos into their patient communication strategies. 

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FAQs:

How does PRIMR navigate the regulatory landscape and obtain IRB approval for its educational videos, especially considering the need for customization and rapid deployment in clinical trial recruitment efforts?

PRIMR navigates the regulatory landscape and obtains Institutional Review Board (IRB) approval for its educational videos by following a meticulous process. Despite the need for customization and rapid deployment in clinical trial recruitment efforts, PRIMR ensures compliance with regulatory requirements by involving professionals, such as board-certified oncologists, in crafting the content. These sessions help tailor the videos to align perfectly with the needs and preferences of diverse patient populations. Moreover, PRIMR collaborates closely with IRBs to address any concerns and obtain approvals efficiently, allowing for timely deployment of educational materials while ensuring adherence to regulatory standards.

What specific metrics and data analytics does PRIMR provide to trial teams to assess the effectiveness of their recruitment campaigns, and how are these insights used to refine recruitment strategies?

PRIMR provides trial teams with comprehensive data analytics and reporting to assess the effectiveness of their recruitment campaigns. These insights include crucial engagement metrics such as impressions, views, watch hours, and percentage viewed. Trial teams can leverage these insights to evaluate the performance of their educational content and recruitment strategies. By analyzing data on video performance, device usage, geographic location, and other factors, trial teams can make informed decisions to refine their recruitment approaches and maximize participant engagement.

What strategies does PRIMR employ to ensure that patient education materials resonate deeply with diverse patient populations, particularly those from underrepresented communities?

The content creation process involves live sessions with board-certified oncologists and patient advocates to ensure that the materials address the unique needs and concerns of various patient demographics. PRIMR also goes the extra mile to translate trial videos, including graphics and narration, into multiple languages determined by the clinical team, ensuring accessibility and inclusivity. These translations are meticulously done by certified professionals to guarantee a credible and empathetic voice that resonates with patients from diverse linguistic backgrounds. Additionally, PRIMR collaborates with trial sites to create print assets with QR codes for point-of-care distribution, allowing for personalized engagement with patients at specific locations. Through these strategies, PRIMR aims to create educational materials that effectively communicate trial information and encourage greater participation among underrepresented patient populations.

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