Advertising guidelines for clinical trials

When creating?clinical trial advertising?materials, it's important to craft outreach copy that connects with patients and care partners. But in order for your Institutional Review Board (IRB) to approve your materials, they must also adhere to guidelines?set out by the Food and Drug Administration (FDA).

Working within those guidelines doesn't mean your outreach has to be dry, but it should be clear and honest. Follow these tips to ensure your materials are complying with typical IRB guidelines to give you the best shot at approval, while connecting with patients and care partners, too.

What are the FDA regulations for advertising clinical trials?

The?FDA considers?advertising clinical trials to patients to be part of the informed consent process. Any patient-facing materials must be submitted to the IRB for your trial, but materials created for other purposes may not need to be submitted. Before you submit your materials, check the list below, as well as past IRB submissions, to confirm what does and does not need to be included in your submission packet.

Materials that must be submitted to your IRB:

• Ad copy for digital channels, including Facebook, Twitter, paid search platforms, and banners
• Website text for a landing page about your clinical trial
• A prescreener for your clinical trial
• Scripts for team members who speak to patients about your trial
• Video advertisements for your trial
• Mock-ups of print advertisements
• Drafts of radio advertisements
• Other patient-facing outreach materials, as noted in?FDA guidelines

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

• Your trial listing on ClinicalTrials.gov or another listing website, such as the National Cancer Institute's cancer clinical trial listing
• Communications intended only to be seen or heard by health professionals, such as doctor-to-doctor letters
• Other materials prepared for non-patient audiences, such as outreach to investors

FDA guidelines for outreach materials

In general, outreach materials should not be coercive. Of course, that can be a relatively subjective judgement, and every IRB is different. The FDA’s general guidelines can help clarify the kind of language that may be considered coercive or otherwise inappropriate by your IRB. These guidelines are in place to help protect patients and avoid confusion about what it means to participate in a clinical trial.

FDA guidelines include:

• No claims should be made that the investigational treatment is safe or effective, or that it is equivalent or superior to existing treatments. This includes both explicit and implicit claims. The IRB will review content, as well as the font size and type, and other visual effects, in determining whether materials are too promissory.
• Outreach materials should not use language such as "new treatment," "new medication," or "new drug" without explaining that the treatment is investigational. In other words, "new investigational medication" may be approved, but "new medication" would not be approved. Such phrases may lead patients to believe that they will be receiving a treatment that has already been approved by the FDA, or has already been proven effective.
• Outreach materials should not promote "free medical treatment" to refer to study-related care patients will receive
• If the trial is paid, compensation may be mentioned, but not emphasized through larger or bold type

Though not required, the FDA also recommends that ads include the following information to help patients make the decision to take part in a trial:

• The name and address of the research site
• The condition under study
• The purpose of the research
• A summary of eligibility criteria
• Participation benefits, within FDA guidelines (i.e., not promising a symptom benefit)
• A general description of the time commitment for the trial
• Who to contact for more information

Depending on the ad platform, you may not want to include all of that information in a single ad. Choose the most concise and critical information, and consider creating multiple ad variants that include different messaging to find out what details resonate most with your audience.

Submitting graphics, images, and videos to your IRB

In addition to reviewing outreach copy, your IRB will also want to approve any graphics, images, and/or videos you plan to use in promoting your trial. Facial expressions, settings, and actions in your imagery may implicitly communicate messaging that’s not allowed by the FDA.

Images that imply results from the treatment may be considered too promissory by your IRB. For example, for an exercise-induced asthma trial, you don’t want to show people running marathons. While images shouldn't imply benefits from the trial, try choosing ones that convey life with the disease or that capture a positive experience interacting with medical professionals. Make sure that the images accurately portray your patient community, too.?

One safe route is to depict empathy or empowerment, which can be just as effective and are less likely to be rejected by your IRB.

If you choose to use imagery with pills or another image of medication, such as an inhaler, make sure the trial is using the same kind of intervention to avoid confusion.

Other clinical trial advertising best practices

In addition to adhering to FDA guidelines, it's also important to create advertising materials that connect with patients. When designing outreach materials, consider these tips to help ensure your ads are patient-friendly while still following the rules.

Research advertising policies on digital media platforms.?You should do this?before?submitting your outreach materials. Not only do certain platforms like?Facebook?and?Google ads?have advertising policies and restrictions, but they also have character limits. It’s critical to make sure you’re submitting materials to your IRB that you’re confident will be approved by the digital platforms you plan on using for advertising.?

Talk about the condition the same way patients do.?Use patient blogs, advocacy groups and nonprofits, social media, and message boards to understand the language patients use to discuss their condition. This research can help you avoid using jargon to discuss your trial, and ensure patients will understand your ads.

Be mindful of reading level.?As you create your outreach materials, keep in mind that?the average American reads at a 7th-8th grade level, and most likely does not have a medical background. Websites like?Hemingway Editor?can help you measure the readability of your content and reading level, and provide you with tips on adjustments you can make to improve the accessibility of your content.

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 the quality of their life; and 3) receiving support from doctors. Include the most critical, and engaging, information you can in your ads based on your understanding of what is most important to the population you are looking to reach.

Clinical trial recruitment tools

When you're ready to start recruiting for your clinical trial, there are a range of tools you can use to engage patients while following FDA regulations. These tools include:?

Digital pre-screeners and websites:?One simple tool for improving patient eligibility is a digital pre-screener. Links to these landing pages – which do require IRB approval – can be shared across different advertising channels to help identify patients who may qualify for your 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 your sites time by connecting with patients who are already 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 the right patients.

Promotional videos:?Short promotional videos are another way to engage patients and share the benefits of taking part. Many social media platforms, like Instagram, have prioritized video in some form or other. 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. Videos of doctors or patients can also help build trust with patients.?

Today, patient recruiters don't necessarily need a big budget or team to create videos. 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 your site locations can share information about trial opportunities, and have 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 also 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 for those taking particular medications.?

Patient networks through nonprofits:?Disease nonprofits, patient advocacy groups, and other organizations?may be interested in helping you connect with patients in a particular area, or more broadly if you're working with a national organization. You may be able to promote your trial at an in-person or virtual event, through the organization's email list, or through social media. Patients may 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 your trial's goals.

Patient registries:?Your study site or recruitment vendor 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 your 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 your trials.?

Looking for help with clinical trial patient recruitment advertising and design? Visit the Antidote website today to learn more.