Clinical trial advertising guidelines

Creating clinical trial marketing materials is a delicate balance — it's important to craft outreach that connects with patients and care partners, but it’s also important to adhere to the guidelines set out by the Food and Drug Administration (FDA) to receive the approval of the Internal Review Board (IRB).

Despite the strict guidelines, outreach materials do not have to be dull. In this article, we’ve outlined tips to ensure that materials comply with typical IRB guidelines while resonating with patients and care partners, too.

What are the FDA regulations for clinical trial outreach?

The FDA considers clinical trial digital advertising materials part of the informed consent process, so any patient-facing materials must be submitted to the IRB for approval. This typically includes collateral such as:

  • Ad copy for digital channels, including Facebook, Twitter, paid search platforms, and banners
  • Photos and videos that will be used in advertisements
  • Copy for the landing page these ads point to
  • The clinical trial prescreener
  • Scripts for team members who speak to patients about the trial
  • Mock-ups of print advertisements
  • Drafts of radio advertisements
  • Any other patient-facing outreach materials, as noted in FDA guidelines

Materials that do not have to be submitted to your IRB:

  • The trial listing on or other listing websites
  • Communications intended to only be used by health professionals, such as doctor-to-doctor letters
  • Any materials prepared for non-patient audiences, such as outreach to investors

FDA guidelines for outreach materials

The FDA’s general guidelines are in place to help protect patients and avoid confusion around what it means to participate in a clinical trial, ensuring that language is not coercive or making guarantees about the experience. These guidelines state the following:

  • No claims should be made that imply that the investigational treatment is safe, effective, or superior to existing treatments. The IRB will review content, font size, type, and other visual effects to determine whether materials are too promissory.
  • Materials should not make use of the word “new” without explaining that the treatment is investigational. For example, a phrase such as "new investigational medication" may be approved, but "new medication" would not, as such phrases may lead patients to believe that they will be receiving a treatment that has already been approved by the FDA.
  • Outreach materials should not use the phrase "free medical treatment" to refer to study-related care that results from patient enrollment
  • If the trial is paid, compensation may be mentioned, but not emphasized through larger or bolded type

Submitting graphics, images, and videos to your IRB

In addition to reviewing outreach copy, the IRB will also want to approve any graphics, images, and/or videos that will be used to promote the trial, as facial expressions, settings, and actions in the imagery may implicitly communicate messaging that’s not allowed by the FDA. For example, in a trial for exercise-induced asthma, it may be prohibited to show people running marathons.

While images shouldn't imply benefits from the trial, choosing ones that convey life with the disease or capture a positive interaction with medical professionals can be helpful. Make sure that the images accurately portray the patient community the trial aims to reach, too. 

Other clinical trial advertising best practices

In addition to FDA guideline adherence, it's also important to create advertising materials that connect with patients. When designing outreach materials, consider these tips to create patient-centric ads while still following the rules:

Research advertising policies on digital media platforms. Before submitting outreach materials, it’s important to be familiar with the guidelines from platforms like Facebook and Google ads regarding their advertising policies and character limits. After the IRB approval process is complete, it is difficult to add or edit materials, so it’s wise to make sure any collateral submitted will be eligible for publication.

Talk about the condition the same way patients do. Blogs, advocacy groups, nonprofits, social media, and message boards can be great resources to understand the language patients use to discuss their condition. This can identify jargon that might be helpful when drafting outreach copy that can help ensure patients will understand your ads.

Be mindful of health literacy. As you create your outreach materials, keep in mind that the average American reads at a 7th-8th grade level, and only 12% of Americans are considered health literate. Websites like Hemingway Editor can assess the reading level of content and provide tips on adjustments to improve accessibility.

Share information that matters to patients. In a survey Antidote conducted of 4,000+ patients, patients’ main motivations for joining trials were 1) receiving health care for free or at a reduced cost; 2) testing a drug, therapy, treatment, or medical device that could potentially extend or improve quality of life; and 3) receiving support from doctors. Based on what is most important to the patient population targeted in a study, consider highlighting some of these benefits of participating.

Clinical trial recruitment tools

When it’s time to start recruiting for a clinical trial, there are a range of tools to engage patients while following FDA regulations. These tools include: 

Digital pre-screeners and websites: One simple tool for improving the patient experience is a digital pre-screener. Links to these landing pages can be shared across different advertising channels to help identify patients who may qualify for a trial. While some eligibility criteria, such as disease symptoms or lab test results, may need to be confirmed or further evaluated at the site level, online pre-screening through a patient recruitment company can help save sites’ time by connecting with patients who are more likely to be qualified. 

Social media advertising: With approximately 90% of Americans using the internet, digital outreach can be a strong approach for almost all disease areas. At the same time, it's important to note that digital advertising for clinical trials can take time and expertise to get right. Some eligibility criteria may be too specific to target through tools like Facebook, making smart ad copy even more important in ensuring ads reach eligible patients.

Promotional videos: Short promotional videos are another way to engage patients and share the benefits of research participation, and many social media platforms have prioritized video in recent years. In a survey from SocialMediaToday, 70% of marketing professionals reported that video converted better than any other medium. Videos are highly shareable and can highlight details about the trial in an easy-to-digest way, and it’s easier than ever to create them on a limited budget. Tools such as Promo and Biteable allow marketing teams to quickly create short, shareable videos for organic promotion and advertising. 

Blog posts: In addition to running direct acquisition campaigns to enroll patients into trials, building awareness of the trial or research in general through blog content can also support patient recruitment efforts. Research suggests that after patients learn more about how clinical trials work, they have a more positive perception of participating. Blog posts and other educational content can help build an informed audience for a clinical trial.

Local physicians: Patients may be more likely to participate in a clinical trial if they hear about it from their doctors. In our survey, all groups across therapeutic areas and socioeconomic statuses were most interested in speaking with doctors and research coordinators when considering their trial options. Physicians near site locations can share information about trial opportunities and provide insight into whether a patient may qualify, as well.

Electronic health records (EHR) matching: In addition to connecting with individual physicians, some clinical trial recruitment companies use technology that matches EHR information with your trial's information to find potentially eligible patients. For example, study teams may look for patients with specific lab values or those taking particular medications. 

Patient networks through nonprofits: Disease nonprofits, patient advocacy groups, and other organizations may be interested in helping researchers connect with patients with a particular condition. It may be able to promote a trial at an in-person or virtual event, through the organization's email list, or through social media. Patients may also be more interested in participating if they hear about the trial from a source they trust, so organizational partnerships can be an effective way to reach a trial's goals.

Patient registries: Study sites and recruitment vendors may have a registry of patients who have expressed interest or participated in trials in a particular condition in the past. Complex protocols can make patient registries less effective, but they can still offer a helpful repository of patients interested in research or familiar with the research site. 

Traditional advertising: While digital advertising has far more targeting options to make for more precise outreach, traditional advertising can also have a place in clinical trial recruitment efforts. Radio and newspaper advertisements for trials researching common conditions such as type 2 diabetes or asthma, for example, may be more effective than traditional advertising for rare conditions. 

Full-service patient recruitment companies: Clinical trial patient recruitment companies may specialize in particular outreach methods, or use a range of approaches to connect with patients. In addition to running recruitment campaigns, they may also offer site follow-up services, patient engagement tools, and other methods for connecting interested patients with trials. 

Looking for help with clinical trial patient recruitment advertising and design? Contact us today to learn more about how Antidote connects patients with research.