We recognize that succesful clinical trial enrollment involves the development and implementation of a well thought out and executed strategic plan. During study feasiblity is a perfect time to start thinking about outreach efforts to allow for strategy, tactical, and budget development. Once activities are in motion they should be treacked and evaluated throughout the project and adjusted according to results.
The following is an overview of subject recruitment strategies and tools, as well as a cross section of recruitment resources available to research teams. We're here to help you achieve your enrollment goals! For more information about resources and assistance with developing recruitment and retention strategies contact JCTOSRC@med.cornell.edu.
Subject Recruitment and the Institutional Review Board Approval
Of note: All recruitment strategies, materials, and avenues must be approved by the IRB before they can be implemented or distributed. IRB guidelines on human subject recruitment can be found here.
Developing a Recruitment Plan
The type of strategy and tactics developed should vary depending on the demographics included in the study i.e. age (adult vs children), ethnicity, disease, or disorder. Whichever avenues your team chooses to engage, simple to understand lay language and regular maintenance is key to successful outcomes. Please see guide on developing a plan.
Develop a Budget
Whether you will be recruiting from your patient base or planning extensive outreach efforts, we recommend allocating funds in your overall study budget upfront. Although pharmaceutical companies may include funding for recruitment and materials, the amount or strategy may not match what is needed for our immediate catchment area or patient population. Planning early and providing rationale to sponsors will help your team to succeed in its enrollment and retention efforts.
Develop Multiple Recruitment Tools
With people being connected 24/7 on multi-channel platforms, it's worth considering an array of recruitment tactics. The more targeted the components are in a recruitment plan, the greater the likelihood it is that enrollment will be successful.
When you have an approved recruitment budget and IRB approval for the recruitment tools your team is ready to launch the campaign! Be sure to have a system in place to track the responses you receive. Be specific about the information tracked, including participant name, relevant details about interactions, screening visit date, enrollment date, referral details (how did they hear about the study?).
This tracked information will help to inform a) ways to adjust recruitment efforts and b) cost per subject for recruitment and enrollment. Which in turn helps to determine future outreach efforts re: which areas worked best and which didn't.
Recruitment Tools and Resources
Follow are some examples of internal and external resources available that can be utilized as part of your team's recruitment strategy. Prior to moving forward, please refer to the policy for subject recruitment materials and advertising. You can also access the Researcher's Toolbox subject recruitment tools and templates.
JCTO Clinical Trials Website Search Feature
In order to provide the general public with the most robust options for participating in a clinical trial, including healthy volunteers, we require interventional and observational studies to be posted on the JCTO webiste. When submitted a study at the CSEC time point, please include the clinical trials summary template. Once approved, please submit the Word document to JCTOSRC@med.cornell.edu. Once posted, you can use the link to promote your study online via social media. You can also create a QR code with the URL for including on study-related flyers and other printed materials. This allows people to scan the code with their mobile device and it brings you directly to the study listing on the site. Of note: you must include "online" as part of your recruitment strategy in the eIRB application.
The Clinical and Translational Study Center (CTSC)
Research Match - a website that brings potential research subjects and investigators together (requires an approval letter from the IRB for posting studies)
Architecture for Research Computing in Health (ARCH) - support for prospective and retrospective studies
Cohort Discovery (i2b2) - discover cohorts of patients using data from EHR systems - support for study feasiblity and (potentially) studies behind in recruitment efforts
EPIC alert - request allows for automated alerts to research teams when your (out) patients may be eligibile for a clinical trial
Eclipsys alert - request allows for automated alerts to research teams when your (in) patients may be eligible for a clinical trial
As with any tactic, social media can be an effective way to support your recruitment efforts, though requires regular maintenance and engagement. To be successful a dedicated member of the team needs to provide regular content and monitor the channels. Weill Cornell Medicine External Affairs has a policy on social media and approval is required for department/devision accounts prior to moving forward.
Facebook can be an effective recruitment tool and allows for a bit of expanding on the subject matter and engagement in a post. They offer free access, ability to boost posts, and to create and place ads. If you're interested in paid avenues, please take the time to review the guidelines for each. Boosts are a cost-effective way to get in front of your targeted audience and can be done for as little as $5.
Through this platform you also have access to patient groups that range from those created by people living with diseases and disorders to organizations that support those groups (please exercise sensitivity if you approach these groups and do it via messaging or if there is an e-mail available). These groups can be a viable mechanism for getting your study posted, though the page administrator is the best resource for this avenue.
A business page may already exist for your department, division, or center (examples) please check with your administrator. If there is already a page available, your studies can be posted on that page. If you don't already have a page, it's possible for one to be created, though you need a strong imperative and someone to maintain it on a regular basis. There are also external vendors like TrialSpark who specialize in this area of recruitment.
Twitter is used for biref information dissemination and engement of up to 140 characters, including links (soon to change). You might use disease or disorder group hashtag or @ a well-known organization, a link to the study, and potentially a quote card with more information, or a link to a video where the PI and/or volunteer is talking about the study. Your physician, department, division, or center may also have a Twitter account and setting one up specifically for a study is not the norm. You can set up a business feed and pay for promoted posts, though this avenue is not widely used compared to Facebook.
Most online initiatives where you pay for marketing (Facebook post or page boost and ad, Twitter ad, Google ad) can be targeted based on geo location, meaning they can get fairly granular in terms of locating the population demographics of a study.
CraigsList is a free service that allows for posting your clinical trials. Most studies are posted under the volunteer section. Depending on the way your account is set up, you can include a flyer, though you must include the IRB protocol number and study expiration.
Clinical Connection is a site that allows members of the general public to opt-in to receive information about clinical trials in their area. Once the study is posted, anyone who asked to receive information about a study in their area will receive a notification (daily, weekly, etc.). Weill Cornell is considered a site and the cost to post studies is nominal. In order to help support utilizing this avenue in your outreach efforts, they are able to provide numbers of people in your targeted area who are interested in a clinical trial for a specific disease.
Many of these newspapers have websites and offer combination packages of print and online advertising in their health section or classifieds.
free daily (MetroNews, amNewYork); minority outreach (Amsterdam News, El Diario)
major dailies (New York Times, Daily News, New York Post)
E-mail & Snail Mail Blasts
E-mail blasts can be done via provider association, and is typically a one-time event where the research team supplies the recruitment materials / information to the organization and they distribute (snail mail labels can be purchased for one time use), via marketing companies like INFOCUS (e.g. American College of Rheumatology member mailing list). Locally, websites like dnainfo can include ads in their e-mails, as well as banner ads on their website.
Subway & Buses
The Metropolitan Transit Authority (MTA) has many different ways in which you can advertise in their system (billboards, buses, commuter rails (LIRR & MNR), back of MetroCards, On the Go Kiosks, subway cars and stations, panels leading into the subway. Given the cost associated with this kind of large scale ad buy, we recommend reserving for studies where you are enrolling a substantial number of people or possibly using it for your group clinical trial program.
TV & Radio
Depending on your patient population and size, cable TV (e.g. NY1, WABC, WNBC, WCBS Fox) and radio (e.g. 1010WINS / WCBS / WFAN), WNYC, and more) may be effective tools in your outreach efforts. Many also have an online component when you purchase airtime. For example, recruiting for mental health, addiction, and sleep studies, you might consider outreach overnight where the demographic is likely to see it, as well as keeping costs down compared to prime time. Of note: these avenues typically need substantial budget.
Many communities around the NYC area have street fairs where healthcare offerings are featured. You can also reach out to local community boards, centers, religious organizations, etc. To find out more about these options, please contact our colleagues in the CTSC. Having people knowledgeable in your clinical holding informational sessions about the study, including handing out engaging materials is a key to being successful.
Not sure of the best way to reach your targeted population?
Ask patients successfully recruited in current trials how they found out about the study, or ask your current clinic patients what resources they use to learn about the disease. In the last few years a growing trend has occurred with “crowdsourcing protocol development,” which can include researchers, clinicians, and patients providing input into the design of the clinical trial / protocol.
These people can be great partners as you develop your plan.
Reach out to people who are interested!
When someone contacts you about a study and doesn’t return a call or e-mail immediately, try following up at least three times. On average it takes the public hearing or seeing something 2.5 times before they act on it.
Want to help people get to your office for the study?
Consider partnering with Uber & Lyft. These companies are moving forward with services for getting people to healthcare appointments.
Track your recruitment sources for successful outcomes!
In order to evaluate the effectiveness of a recruitment strategy, it is important to collect the source of recruitment for each volunteer. This tracking can be done as part of the telephone screening or initial intake form for new patients. Evaluating the effectiveness of various recruitment efforts as they are taking place allows you to move resources away from efforts that are ineffective to strategies that are more successful. The tools for recording recruitment sources should be planned before recruitment begins.
All of the above is meant to help you as you plan your subject recruitment and retention strategy. If there is an avenue you don’t see above and would like to explore it or if you have any questions, please reach out to JCTOSRC@med.cornell.edu.