Key takeaways
Modernize processes for site-initiated ads: Sponsors and CROs must establish clear, timely workflows for reviewing and approving site-generated materials to prevent recruitment delays.
IRB collaboration is critical: IRBs should focus on participant protection without overstepping into editorial decisions, enabling more effective, up-to-date outreach.
Flexibility drives enrollment: Allowing sites to tailor advertising to their local communities—within a compliant framework—can significantly boost recruitment success.
Patient recruitment is among the most pressing challenges facing clinical research today. According to recent industry assessments, as many as 85% of clinical trials fail to meet their recruitment goals, often leading to higher costs and missed opportunities to deliver potential therapies to patients in need.
In the face of these daunting odds, advertising—when done well—is a promising solution. After all, promoting clinical research opportunities directly to the public can effectively match potential participants with an appropriate study. Unfortunately, regulatory guidelines are outdated, sponsor-provided materials do not always meet site needs, and sponsors and contract research organizations (CROs) too frequently don’t have a defined process allowing sites to create their own trial marketing materials.
Outdated marketing regulations
FDA guidance for institutional review boards (IRB) on clinical trial advertising dates back more than a quarter century. When that guidance was produced in 1998, the advertising landscape looked much different than what it does today. Social media and smartphones were not widely prevalent, and digital advertising didn’t exist. Today, sponsors and CROs find themselves severely constricted in a world where a vast array of bespoke digital advertisements—from hyper-targeted search engine display ads to TikTok’s mysteriously effective algorithm—dominate the landscape.
While IRBs are stuck with essentially applying 1990s guidance to a 2025 reality, the underlying premise of the FDA’s long-standing position holds true: any advertising that promotes a specific study is considered part of recruitment as the beginning of the informed consent process and therefore must be reviewed by an IRB. What’s missing, however, is appreciation for the many methods within which patients can be engaged. It’s long past time to acknowledge that patients are consuming information much differently now than they did decades ago, and IRBs must work proactively with both sites and sponsors to appropriately oversee a modern advertising landscape.
Marketing materials that do not meet site needs
Trial-specific marketing materials include items such as print ads, digital ads, flyers, and social media texts. These are typically developed by the sponsor and created by a central marketing team. After being submitted to the IRB and approved, these ads are then distributed to all participating sites in the study. The key advantage of sponsor-initiated advertising is consistency because it aids in efficiencies of time, which is a particularly important element in multi-site studies.
“From the sponsor perspective, this is critical for studies where you need each and every type of site contributing to your enrollment goals and timelines,” said Meghan Joseph, director of site engagement and support at Moderna. “It’s also much more cost-effective to produce a single version of an ad rather than 50 versions.”
But the sponsor-initiated ad model also has its limitations.
"Not every site or every community are the same,” Joseph added. “They have very different needs when it comes to where and how they show up for their patients.”
Being flexible about how ads are developed can help ensure that more prospective study participants can be reached.
“Ads provided by sponsors may not offer options for advertising on social media or search engines,” said Matthew Maxwell, chief growth officer at Centricity Research. "Sponsor ads can also be too specific or, in some cases, too bland to be effective. Sites often need flexibility to engage their communities in different ways."
The rise of site-initiated marketing materials and increasing need for sponsor-CRO processes
Whether ads are created centrally (by the sponsor) or locally (by the site), timing is key. It’s so important, in fact, that sites are often willing to take the initiative on their own. According to a recent study by the Society for Clinical Research Sites (SCRS), more than half (53%) of sites choose to use their own money to fund recruitment.
Unfortunately, many sponsors and CROs either do not have their own internal process for what to do when a site submits such materials to them for pre-approval, or the sponsors and CROs have not discussed how the process will work between them.
Explaining the process may be helpful here. First, the site created their own materials. For the sake of this example, let’s assume it’s a Facebook ad and the wording of a post for X. It is never appropriate for the site to submit trial-specific materials to an IRB because it is the sponsor’s trial; as such, the sponsor needs to consent to the ad being submitted to the IRB before it can be sent. But the second step is not submission to the sponsor; it’s submission to the CRO. The site sends the request to the CRO and waits to hear back. (This is where the delays occur. In some cases, the trial might even close before sponsor authorization to submit materials to the IRB arrives.) The final steps are that the site receives sponsor/CRO pre-approval, and then the material is submitted to the IRB.
As Joseph explained, “As a sponsor, we should want to enable and empower our partner sites to effectively and compliantly engage in outreach with their patient community about a study opportunity. But many sponsors simply don’t have a streamlined system for reviewing site-generated ads.” In fact, not only do sponsors need to have processes for site-initiated ads, but sponsors need to make that process clear to the CROs they work with, as sites are usually asked to first send their ad requests to the CRO. The CRO then requests approval from the sponsor, and that approval is required before the site may send any trial-specific advertising materials to the IRB.
Creating two tracks for trial marketing plans
Marketing and advertising for clinical trials generally falls into two main categories: materials that are sponsor-initiated and those that are site-initiated. Sponsor-initiated materials offer consistency across study sites; they also tend to offer high-quality advertisements. Sponsors almost universally have a process for creating and distributing these, and CROs are made aware of the process.
It may not always be the case that sponsors want to approve site-initiated materials, but it nonetheless must be recognized that sites can draw from a variety of community insights to tailor language and messaging and deliver ads that make sense to their local prospective audiences—all of which may increase study enrollment. It thus behooves sponsors to develop processes that offer timely review of site-initiated marketing materials, including who is responsible for review, and with training for the CROs on this process.
Practical tips for success
Ultimately, the goal of clinical trial advertising is not aesthetics, nor is it just checking a box that a task was completed. The goal of clinical trial advertising is enrollment. When those creating the marketing materials (sponsors, sites) and those reviewing the ads (IRBs) work collaboratively, the result is materials that are compliant and impactful. Here are some ways all parties can collaborate to make this process better:
Sponsors must act early and thoughtfully
Sponsors should deliver usable, patient-centered materials, designed with flexibility in mind, by the site initiation visit.
"Delays in recruitment cost hundreds of thousands of dollars per day,” Maxwell explained. “But well-executed advertising—especially ads that are tailored by the sites themselves—can accelerate enrollment and save money.”
Moreover, ads should also be thoughtfully produced. “Ideally, sponsors draw from their previous experience, as well as patient and site knowledge to create a centrally approved set of materials,” Joseph added.
Sites need defined internal processes and an understanding of the IRB’s purpose
Sites must train their staff, plan for IRB submissions, and advocate for materials that reflect their local communities. The language in any marketing item needs to be clear, accessible, and free of medical jargon. The goal should always be to inform, not overwhelm.
Sites must also be familiar with the specific guidelines for the IRB being used. By way of broad explanation, IRBs review materials to ensure they are not coercive, do not imply guaranteed benefits, refrain from overemphasizing the compensation participants might receive, and clearly indicate the investigational nature of the treatment.
That said, even the most prepared sites can be hampered without strong sponsor collaboration. Having a clear, shared plan can make all the difference: “We created a process that our study teams, our CRO partners, and our site partners are trained on,” Joseph said. “And this removed the duplicative reviewers from the process entirely.”
IRBs should apply FDA guidance by understanding its intent
Until FDA guidance is updated to better reflect the current media landscape, changes requested by IRBs should be those aimed at protecting participants, not editorial changes. The Secretary’s Advisory Committee on Human Research Protections (SACHRP) of the US Department of Health and Human Services recommends that IRBs focus their review on substantive issues relevant to participant protection and avoid tangential matters (“mission creep”), which can distract reviewers from their primary purpose.1 IRBs must protect patients, but that doesn’t negate their ability to apply guidance in a way that is mindful of the recruitment challenges that sites regularly face. Applying rules fairly, consistently, and with the greater good in mind positions IRBs as both a source of protection and as a partner to sites and sponsors in supporting ethical trial enrollments.
Think beyond the ad
In instances where the formal ad approval process falls short, integrated marketing strategies can help bridge gaps in recruitment.
“When all else fails,” Maxwell emphasized, “remember the importance of a holistic marketing strategy: blogs, video content, webinars, organic social media posts, thought leadership pieces, and events can all play an important role in dealing with inevitable delays.”
By evolving trial advertising practices using the same rigor and care the industry brings to study design, faster and more productive trials will result. And ultimately, this will lead to better outcomes for everyone. Participants will gain greater access to research opportunities, sites will be empowered to connect with their communities more effectively, and sponsors will benefit from reduced delays and stronger engagement.
When we treat advertising as a strategic, collaborative element of trial execution, medical breakthroughs happen.
Christine Senn, PhD, FACRP is the SVP of Site-Sponsor Innovation at Advarra
Reference
1. https://www.hhs.gov/ohrp/sachrp-committee/recommendations/tab-c-the-protection-of-non-subjects-from-research-harm.html
