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PATIENT RECRUITMENT IN CLINICAL TRIALSDefine your targetaudienceBefore you start reaching out to potentialparticipants, take the time to research andunderstand who it is you’re trying to reach with yourrecruitment efforts—what is your target participantpopulation?Answer these questions to maximize theeffectiveness of your recruitment plan:Who is your ideal participant?The inclusion/exclusion criteria associated with theprotocol is a good place to start when answeringthis question. Identify the target demographicsof your ideal participant, including factors suchas gender, age, location as well as specificprotocol requirements. Determine where thepeak prevalence/incidence rates are, and let thatinformation guide your recruitment strategy.12However, be careful not to limit your reach too much.If your specifications become too narrow, it may betough to market to that group; keep your definedpopulation as high-level as possible.Where does your ideal participant go forinformation?To know where to publish ads to promote a trial, youneed to know where your audience will see them.What channels do they visit?Demographics often play a key role in where apatient is most likely to search for information.For example, a 19-year-old patient is probablymore likely to search social media sites, whereasa 70-year-old patient may find information in anewspaper. Choose the information outlets youknow your audience will be using, eliminating theneed to advertise in places that will provide little tono results.

PATIENT RECRUITMENT IN CLINICAL TRIALS13How does your ideal participant engage with advertisements/content?To increase the likelihood that your ideal participant will payattention to your study ads, you need to know what types ofcontent they are most likely to engage with. Is your audiencemore likely to download something? Or would they rather hold apamphlet in their hand? Do they prefer to read a blog post? Or arethey more likely to watch a video ad?Think about how your target audience would engage with thecontent you are looking to provide. Multiple internal and externalfactors can affect the type of content a patient is most drawn to,including literacy, attention span and available time. Adaptingstudy ads into the easiest and most enjoyable format for your idealparticipant will likely provide better results.

PATIENT RECRUITMENT IN CLINICAL TRIALSDevelop messagingthat resonates with youraudienceAgain, delivering a message that resonates beginswith knowing your audience. Look back at yourtarget participant population and determine whatmight motivate them to participate in your clinical14Take your identified motivators and try to find themost meaningful message for that population.Determine what message will drive your idealparticipants to find out more about your trial. Allthe while, remember that your messaging must beIRB-approved and void of any potentially coercivecontent.trial. Are they seeking new treatment? Will they benefit from the medical exams that willbe provided free-of-cost throughout the study? Is lack of health insurance inhibiting their treatmentoptions?Also consider whether or not your target populationis motivated by altruistic reasons. Is it motivating for people to know they’recontributing to the research community? Do they know someone affected by the studydisease?Tip: Don’t be afraid to explore theemotional side of advertising toprovide relevant and resonatingmessages for your population.

PATIENT RECRUITMENT IN CLINICAL TRIALS15Establish your online advertisingdatabaseAs you’re engaging with potential participants it’s important toTip: It’s good practice to be upfront with your participants whenit comes to email advertising byletting them know what they cancollect their email addresses. This allows you to follow up withthem to provide additional information and content that could leadthem to take action and agree to participate in your trial. Even ifthe participant isn’t interested in the study you’re promoting now,they might be interested in a future study you conduct.expect from you. This helps buildHowever, it’s important to note that you need to gain antrust with those in your databaseindividual’s permission if you want to communicate with them viaand could influence their choiceto engage with your site in thefuture.email. The Federal Trade Commission (FTC) has very clear rulesabout email communication in the CAN-SPAM Act. Permissionis clear consent from the individual to receive marketingcommunication in the future. This can be accomplished by addinga checkbox to your email sign-up that clearly states an opt-into your email communication. For example: “I agree to receivee-mails from X company for information about future studies andorganization news.”

PATIENT RECRUITMENT IN CLINICAL TRIALS16Create compelling and valuablecontentInstead of pushing information on your population, deliver helpfuland valuable content that attracts the right participant. Think aboutTip: Participant quotes and socialproof are a great way towhat content is helpful for your population. What can you providepotential participants that they will be grateful for?encourage positive perception ofDelivering content that’s genuinely useful for your targetyour site. A common statistic sayspopulation builds trust with potential participants. Having already90% of people will believe socialproof from someone they don’teven know as opposed to anadvertiser.gained value from your content, they may be more likely to takeaction and learn more about your study. A blog can be a very easyway to create content on your website that continues to bringpeople back to your site and encourages engagement. Bloggingis also a great way to connect with your community in generaland share the purpose of why your organization conducts clinicalresearch.

PATIENT RECRUITMENT IN CLINICAL TRIALS17Know where to put youradvertising materialsTip: It’s also important to thinkoutside of the box when determining where to put your advertisingmaterials. While the essential 3 L’sand 3 P’s could get yourOnce you have your messaging and advertising materials,you need to know where to put them to connect with the rightpopulation.Consider tactics for building clinical trial awareness by developingan understanding of your target population and placing advertisingmaterials where they live, learn, labor and pay, pray, play. Thismessage in front of the rightframework was developed by Karen Brooks, PhD candidate atpeople, a different tactic may proveTrident University, and she calls it the 3 L’s and 3 P’s. Its principalmore engaging and encouragegreater action from your idealparticipants, such as mailing abrochure along with people’s waterbill to build far reaching awareness.is that exploring the everyday actions and priorities of your idealparticipant can help you think deeper about how and whereit’s best to reach them with your messaging. If you know youraudience well enough, you know where all of these places are.

PATIENT RECRUITMENT IN CLINICAL TRIALS18Deliver a clear call to actionA critical part of any advertising campaign is a clear call to action.Determine what you want people who see your advertising to doand make sure it’s very clear what their next step is.Tip: Your call to action should beobvious enough that if someoneskims your content, whether it’s ablog post or brochure, they knowwhat action they should take.Make it as easy as possible foryour ideal participants to take thenext step. Do you want them to call and sign up for more information aboutthe trial? Should they attend an info session you’re hosting? Would you like them to provide their email address?

PATIENT RECRUITMENT IN CLINICAL TRIALSChapter 3Launching your recruitmentcampaign

PATIENT RECRUITMENT IN CLINICAL TRIALS20Determine where to spend yourmoneyOne of the most important aspects of your recruitment campaignis your budget. When budgeting for recruitment advertising, youalways want to create context by defining your goal. Ask yourself,how important is this protocol to your site this year? What is thepotential return for your organization?Where to put your dollarsThere are many targeted marketing options today that allow youto be hyper-specific about the population you are targeting andeliminate wasted advertising. When building your budget, try to setaside funds for: Paid ads Social media Google ads Local TV Magazine and radio Print materials

PATIENT RECRUITMENT IN CLINICAL TRIALS21Google AdWords is another good place to put your dollars. Thistool allows businesses to purchase keywords or phrases thattrigger ads to appear on the search results page. When used well,it can be very successful for gaining awareness, as it allows you toTip: If applicable, contact yourinstitutional public relations teamor communications center. Talkwith them and see if they’re willing and able to partner with youto spread the word about yourclinical trial. It’s possible they’llhelp you advertise, or at the veryleast, give you best practices foryour campaign.be strategic with keywords unique to you.Saving costs with free resourcesThere are a lot of low to no cost advertising options out there thatcan help you get your message to the right individuals, including: Organic social media: Social media that you don’t put dollarsbehind SEO: Optimizing your web content to include specific phrasesand words you know people are searching for to increase yourchances of being indexed on the Google search platform Email campaigns: Once you have someone’s email, you cancontact them for free or low cost Word of mouth: Social proof is incredibly valuable, particularlywhen coming from someone the individual knows.

PATIENT RECRUITMENT IN CLINICAL TRIALSPrepare your advertisingmaterialsCreating your advertisements is a big step in gettingyour campaign up and running. Use the messagingyou developed in the previous steps to build wellcrafted advertising materials that appeal to yourtarget population.Develop the creative for your campaignYou know your target population, you have yourmessaging, now it’s time to put together creativeimagery that resonates with the right individuals.Free tools like Canva allow you to easily createcustom graphics for everything from social mediaposts to business cards to flyers.Remember to update your creative to meet therequirements of each separate channel. Forexample, the images on a brochure are going torequire different dimensions than a Facebookpost. However, while each channel may requiredifferent graphic elements, the look and feel of your22campaign should be consistent across all materials.Update your websiteIt’s likely many of the call-to-actions in your webcontent will be to visit your organization’s websitefor more information. Before you post youradvertisements anywhere, ensure your website hasthe necessary information prospective participantsneed to make the decision to participate. Includeinformation about your research site and the clinicaltrial as well as contact information for the right staffmembers. Make it as easy as possible for people totake next steps.Internally communicate the launchDon’t underestimate the importance ofcommunicating your advertising campaign internallyat your organization. Notifying your site staff, aswell as other institutional departments, that you’readvertising for a particular study can encouragesharing and word-of-mouth recommendations,dramatically increasing your advertising reach.

PATIENT RECRUITMENT IN CLINICAL TRIALS23Schedule Social Media posts and adsHave a schedule for when and what you will beIf you’ve decided your target population is likely toposting to each platform: Don’t be afraid to post aengage with ads on social media, it’s important tovariety of different versions of your ad on the sameconsider these tips to help build successful posts:platform throughout a designated time period. Thiscan help guarantee more people see your ad andMake sure your message is appropriate for theallow you to experiment to see which ads are moreidiosyncrasies of each platform: Not only doessuccessful.each platform have unique message requirements(Twitter limits the number of text characters to 140),Meet the image requirements for each differentbut your audience uses each platform for differentplatform: This will ensure your creative elementsreasons. Alter your message to align with the reasondisplay correctly and nothing is skewed orindividuals use each platform. For example, a postmisinterpreted.on Facebook may be more sociable and visual,whereas a post on LinkedIn may be more formal andThere are a lot of free tools you can use to getdiscussion-based.your social media ads out there, including theplatforms themselves. If your site has a companyBe familiar with each platform’s algorithm for postingpage on Facebook, LinkedIn and/or Twitter, you canon people’s timelines: For example, Twitter postseasily create and track the progress of your postcan be quickly buried in a matter of minutes, whileengagement as a page administrator. HootsuiteLinkedIn posts tend to resurface for weeks.is another free tool that allows you to scheduleposts for multiple platforms in a single location andprovides growth and engagement analytics.

PATIENT RECRUITMENT IN CLINICAL TRIALS24Gain regulatory approval forrecruitment materialsIt takes a lot of work to get everything you need to start yourrecruitment campaign on the right track. But, along withdeveloping a strategy to provide the most relevant advertising toyour target population, you also need to ensure compliance. It’sessential to make sure all of your recruitment efforts fall in line withyour IRB and other institutional policies.What to get approvedDo your advertising materials need IRB approval? The answer isvery likely, yes. As a general rule of thumb, any material that youwill be putting in front of a potential study participant needs tohave prior IRB approval.Doctor-to-doctor and researcher-to-doctor communicationlikely needs IRB approval, as well (check with the IRB of record).For example, if you were to send information about a protocol(inclusion/exclusion criteria, etc.) to physicians to encourageparticipant referrals.

PATIENT RECRUITMENT IN CLINICAL TRIALS25Best practices for gaining approvalWhen submitting your recruitment materials forapproval, it’s best practice to also submit the typeof media you’ll be using. Give the IRB a sense ofTip: Be “specifically vague” about wherethings will be located. Including specificnot only of the information you’re presenting towebsites, social media sites and physicalpotential participants, but also the context that it’s in.locations for approval means those areIf possible, include pictures, mock-ups and/or scriptsthe only IRB-approved locations for yourwhen appropriate.advertising materials.You’ll also need to submit a plan for how you’ll beusing the materials. Provide the who, what, when,where, why and how for everything you submit. Tellthe IRB:Certainly, tell your IRB necessary locationinformation, but don’t limit yourself bybeing unnecessarily specific in where the How the materials will be usedmaterials will be posted. For example, in- Who the intended audience isstead of saying you’re going to post an ad What you’ll be using to display themon “www.favoriterecruitmentsite.com” say When and where they will be usedyou’re going to post the ad on “recruit- Why you chose this mediumThis comprehensive information will give your IRBthe necessary context to help them approve yourcampaign.ment websites such mentwebsite.com, etc.”

PATIENTPATIENTRECRUITMENTRECRUITMENTIN CLINICALIN CLINICALTRIALSTRIALSChapterChapter4 4TrackingTrackingyouryourprogressprogress

PATIENT RECRUITMENT IN CLINICAL TRIALS27Know your conversion rateTracking the appropriate data is key to both ensuring youradvertising campaign is successful and preparing you for the nextphase of recruitment. Organizing the follow up of your recruitmentcampaign is critical to seeing return on your invested efforts; andknowing how many participants you should expect to accrue willhelp you estimate the amount of time and resources you shouldarrange for tasks such as screening and scheduling visits withparticipants.Understand what to expectTake a look at both your protocol feasibility assessment andyour advertising strategy to determine the goal, milestone andconversion rate for your recruitment advertising campaign. Goal: How many participants do I need to accrue to this trial inorder for it to be successful? Milestone: How many people do I need to view my advertisingmaterials in order to reach my goal? Conversion rate: The percentage of individuals that view youradvertising materials and ultimately qualify and agree to participatein your study.

PATIENT RECRUITMENT IN CLINICAL TRIALS28Finding your conversion rateDetermining the conversion rate for your recruitment campaigncan help you establish the amount and scope of your advertising,and inform your strategy for distribution and channel. It can alsogive you a better understanding of the amount of resources youcan expect to dedicate to follow-up tasks. The more you track andmeasure your conversion rates, the better prepared you’ll be forthe individuals that respond to your recruitment campaign.The best way to get an accurate estimate of your conversionrate is to look back at the data for similar studies conducted atyour institution. However, if you’re starting out with no historicaldata, a 10% conversion rate is a pretty realistic general startingestimate. For example, if you know your goal is to accrue 100 idealparticipants for your study, you may need to reach about 1,000people with your advertising materials for a 10% conversion rate.When estimating your conversion rate, it’s also important to takeinto account factors such as: Ineligible, screened respondents Referrals that decide not to participate Potential trial dropouts

PATIENT RECRUITMENT IN CLINICAL TRIALS29Preparing for participantsFollowing up with interested respondents in a timely manner iscritical to accrue enough qualified participants. For some sites, thisfollow up is the point of failure for their recruitment efforts. Often inthese cases, the site is not adequately prepared for the amount ofeffort required to process referrals and/or pr

enough participants to trial was identified as one of the top three pain points in clinical trial conduct. So, why is it that such an important element of clinical research is also one of the most difficult to execute? Strategic preparation is critical to successfully recruiting and enrolling qualified participants to a clinical trial.