By Kristen Snipes, Rho

March 26, 2015 | Contributed Commentary | Social and digital media can be powerful tools for recruiting clinical trial participants and speeding up enrollment. In many cases, using social and digital media for recruitment can be a cost-effective option when compared to traditional advertising channels like TV and newspapers. Depending on the patient population, it may bring in new audiences. For example, adolescents and young adults spend a lot of time engaged with social media. However, because using social and digital media are a relatively new channel for patient recruitment, some sponsors, sites, and CROs aren’t as familiar with how regulations apply. There are several regulatory as well as operational considerations any sponsor taking on social media recruitment needs to keep in mind.

FDA regulations regarding product advertising and messaging apply to investigational products as well as marketed ones. For instance, 21 CFR §56, governing the role of Institutional Review Boards (IRBs), extends to social media messaging. As a result, messaging constraints may make certain social media platforms, such as Twitter, inappropriate for promoting products with complex indications or serious risks.

If a sponsor decides to use social or digital media for subject recruitment in a clinical trial, attention must be paid to the overall lifecycle of the recruitment plan from development and launch through maintenance and closure. When contracting with a third party to manage a website for recruitment, sponsors should ensure they are in control and provide oversight of the content as well as monitor performance.

Social media and digital media can have a much more informal feel than traditional advertising venues like newspapers or radio ads. While most of us would ask someone else to review anything we wrote for a newspaper, few of us ask for help before we post something on Facebook or Twitter. From a regulatory perspective, however, these two activities are one and the same if they are being used for patient recruitment. If a message is visible to potential patients, you should assume it will need IRB approval and plan accordingly.

Depending on the type and format of social and digital media you are using, you will need to give some thought to how you will present information to an IRB. For example, if you are promoting a study through Google AdWords, you will need to be able to provide the text of the ad and a static view of the page to which the ad will direct traffic. For a Facebook ad, you will need to include the text used as well as any images and links that are included. A web page will require a visual of the page layout, including text as well as any links provided to the subjects.

If your social or digital media plans include collection of patient information, or if there is even the possibility that patients will submit data, you need to be particularly careful. Two important questions to ask are what information you are collecting and how you will use the information. Avoid collecting anything subject to HIPAA rules and be careful that nothing patients submit would require informed consent. In some cases, you may find that a process that is less efficient is still the way to go. For example, rather than collecting information through a web form that is then submitted to sites, you may want to direct patients to contact a site directly or use a call center with appropriately trained personnel. This plan will also require review and approval by IRBs.

Beyond IRB approval, you will also need to make sure the study sponsor is on board both with what information will be shared in the recruitment process and how it will be shared. Social media potentially has a very broad audience, and once you’ve posted something you have much less control with how it will be shared and distributed than you would with traditional media. Sponsors may be less comfortable with providing detailed study information through social media channels than they would, for example, on a poster designed for doctors’ offices. Information a sponsor has posted on Clinicaltrials.gov is a good starting point, as you will have assurance the sponsor is comfortable sharing that information externally. Use of web pages and social media can also raise questions about the ownership of data and the restriction of access in a public domain, so make sure to address these concerns before posting.

How to Get Started 

For CROs and sponsors that don’t have the necessary expertise in-house to set up a social or digital media campaign, it makes sense to outsource some of these activities. If this is the case, you will likely be better off using a recruitment vendor that offers social and digital media services, rather than a traditional ad agency. If you do go with an ad agency, make sure they have experience working in regulated industries. As you create your recruitment plan, reference the FDA’s Recruitment Information Sheet. Clinical trial advertising through social media should include a fair and balanced representation of risks and benefits. It is also important to provide current, accurate information that is not misleading, which prospective subjects can use to determine their eligibility and interest.  

Social media can be a helpful recruiting tool, but CROs and sponsors alike must remember that regulations that apply to traditional recruitment methods apply here as well. The social and digital media landscapes can be challenging to navigate even when you are not recruiting patients and gathering information, so education before you begin, and patience during the process, are key.

Kristen Snipes, Project Director at Rho, has over 15 years industry experience, primarily as a program manager or clinical operations lead. She has been involved in leading and coordinating all operational activities for complex trials and has a wide range of therapeutic experience including CNS, cardiology, respiratory, and dental programs.