Tips for optimizing patient enrollment into studies

1. Engage patient stakeholders to help you identify and address barriers to participation. Include communitybased organizations that serve populations who experience health disparities.
2. Have a plan and reasonable budget for enrolling participants who are representative of the population that is affected by the disease or condition you are studying. Devote resources to outreach and bi-directional engagement with people from groups that are underrepresented or disenfranchised.
3. Avoid excluding specific populations without justification. Examples include:
   • men with breast cancer.
   • people with brain metastasis.
   • pregnant women.
   • people with limited fluency in English.
   • people with comorbidities. Certain co-morbidity exclusions may decrease your chances of achieving representative enrollment.
4. Choose a plain language study title that conveys at a glance what the study is about.
5. Consider a study design that allows crossover or expanded access to new treatments for patients with advanced disease and limited options if they are initially assigned to receive standard care or placebo.
6. Try to budget for and notify participants about reimbursement for travel or other out-of-pocket costs. Recognize that participation in research can present many burdens, including costs that insurance may not cover, travel to and from appointments, parking, income lost from missed work, child-care and more.
7. Offer multiple enrollment sites including in rural areas; consider reducing appointment burden through telemedicine or combined visits.
8. Draft communications and recruitment materials in language that:
   • people can understand the first time they read it.
   • keeps grammar simple and avoids run-on sentences.
   • avoids jargon.
   • spells out abbreviations.
   • avoids words or expressions that objectify or stigmatize people.
   • conveys clearly the goals and main eligibility in the study title and overview (if possible).
9. Include advocates and other patient stakeholders in the materials development and review process, but do not expect them to be the writers, designers or content providers. Hire professionals to do this.
10. Test your messaging and recruitment materials among members of the study population before seeking IRB approval. Offer them a stipend/gift card/compensation for their assistance.
11. Adapt study consent and patient-facing communications into culturally competent materials in key languages when recruiting participants who might not be fluent in English. Test materials with native speakers who represent the participant community.
12. Consider setting up a website to provide details about the study and to encourage participation from a broad and diverse community.
13. Consider setting up Twitter and Facebook accounts, but make sure there is someone who will keep them updated, interesting and moderated. Make sure to get IRB approval of shorter versions of your recruitment language for social media—longer messages are not conducive to social media.

Engage Patients