Clinical Trial Advertising Guidelines: How to Follow FDA Regulations
When creating clinical trial advertising materials, it's important to craft outreach copy that connects with patients. But in order for your Institutional Review Board (IRB) to approve your materials, your materials also need to 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, 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 Institutional Review Board (IRB):
- Ad copy for digital channels, including Facebook, Google AdWords, and banner ads
- Website text for a landing page about your clinical trial
- A prescreener for your clinical trial
- Scripts for patient liaisons 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 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 considered overly coercive. Of course, that can be a relatively subjective judgement, and every IRB is different. That being said, there are general guidelines put out by the FDA that 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 around 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, payment 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.
Clinical trial advertising examples:
Submitting graphics and images to your IRB
In addition to reviewing outreach copy, your IRB will also want to approve any images 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.
"For example, for an exercise-induced asthma trial, you don’t want to show people running marathons," says Katrina Ambrose, senior designer on the marketing team at Antidote. Images that imply results from the treatment may be considered too promissory by your IRB.
If you choose to use imagery with pills or another image of medication, make sure the trial is using the same kind of intervention to avoid confusion.
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.
"Safe ways to go are depicting empathy or empowerment, which can be just as effective and are less likely to get your ad rejected," says Ambrose.
Other clinical trial advertising best practices
Beyond 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.
Talk about the condition the same way patients do. Use patient blogs, disease 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 an 8th grade level, and most likely does not have a medical background. Websites like Hemingway App can help you measure the readability of your content and reading level, and gives you tips on adjustments you can make to improve the accessibility of your content.
Share information that matters to patients. In a survey from CISCRP, patients reported caring most about knowing the physical location of the trial, the goals of the trial, and the risks and benefits of participation. Include the most critical, and engaging, information you can in your ads.
Clinical trial advertising on Google
The Google Ads, formerly known as AdWords, has some restrictions around clinical trial advertising.
Clinical trial recruitment advertising through Google Ads is only allowed in select countries: Australia, Belgium, Canada, China, France, Germany, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Philippines, Singapore, Taiwan, Thailand, United Kingdom, United States, and Vietnam.
In addition, ads should not suggest that the investigational treatment is safe, or present any "unreasonable expectations" about its effects.
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:
1. Digital pre-screeners and websites.
One simple tool for improving patient eligibility is a digital pre-screener. 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 may need to be confirmed or further evaluated at the site level, such as disease symptoms or lab test results, 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.
2. Social media advertising.
In a CISCRP survey, 58% of those surveyed heard about clinical research through online advertising. With 88% of Americans using the internet, digital outreach can be the right 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 for through tools like Facebook, but for many trials, smart ad copy can help ensure ads reach the right patients.
3. Promotional videos.
Short promotional videos are another way to engage patients and share the benefits of taking part. 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 from 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.
4. 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.
5. Local physicians
Patients may be more likely to participate in a clinical trial if they hear about it from their doctors. In a CISCRP survey, 51% of patients would have preferred to hear about a trial from their primary care physician, but only 23% did. Physicians near your site locations can share information about trial opportunities, and have insight into whether a patient may qualify, as well.
6. 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.
6. 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 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.
7. 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.
8. 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.
9. 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? Download our case studies to learn how Antidote connects patients with research.