Write a comprehensive recruitment and retention plan
Integrate recruitment and retention plans with institutional activities
- Make sure your recruiting activities take advantage of existing services your institution provides. Make sure that what you say about your trial is in synch with the overall messages coming from your institution.
Determine how to screen and identify potential participants
- Set up a system to identify potential participants—ideally using your electronic medical record system. Make sure that whenever a potential participant is “found,” the right staff member is alerted (if not already involved) and knows exactly what to say.
Prepare site-specific trial promotional materials for potential participants
- By tailoring general materials that describe clinical trials or a particular trial, and preparing other site-specific materials (such as facility maps), you convey professionalism and thoughtfulness to participants. Use site-and trial-specific materials that help people understand the trial and participation at your site.
Address diverse and underserved populations
- Historically, racial and ethnic minorities have been underrepresented in cancer clinical trial research. One way to steer toward more inclusive trials is to specifically review recruitment plans and ask whether those plans reflect the community and reach populations that have been overlooked in the past. For example, do the medical practices you plan to reach all tend to have similar patients—or, have you accounted for diversity? Have you identified ways to reach people without Internet access and those whose primary language is not English?
Include plans for community outreach
- Know the groups you are trying to reach. For outreach beyond your own walls, partner with organizations who are known and trusted in the community that can help you and potential participants understand one another and work together.
Include plans to work with referring physicians
- Good working relationships with referring physicians matter to your institution and to clinical trial accrual. Key goals in working with referring physicians include: 1) Keeping them informed about your trial and its value so they can refer eligible patients, 2) Keeping them informed about how patients they have referred for the trial are doing, and 3) Making sure the physicians and their patients have good experiences working with you. Build specific ideas into your Promotion Plan to help establish good mechanisms and responsible habits for staying in touch with referring physicians.
Write a trial-specific Evaluation Plan
- With an effective Evaluation Plan you will be ready to notice, understand, and respond to recruiting challenges. Writing such a plan allows you to think through how you will track accrual, understand barriers, and take corrective action. Many clinical trials fail because the research team waits too long to take action to correct low accrual. Your Evaluation Plan will highlight the tracking tools, procedures, and checkpoints that will keep your accrual on track.
Set milestones, metrics, goals, back-up plans
- These topics will be spelled out in the Evaluation Plan. We highlight milestones, metrics, goals, and backup plans here because they are so important. In addition, learning a bit more about each of these key parts of evaluation can help you to plan this work more effectively.
Determine methods for tracking accrual progress
- Your ability to track accrual progress depends on two factors—the tools you use and disciplined, responsible, and complete data entry by staff.
Set accrual performance thresholds (e.g., time from trial opening to first participant enrollment)
- AccrualNet™’s evaluation section focuses heavily on getting your tools and your team situated to deliver complete and “actionable” accrual data in real time. By setting thresholds in advance, you preset triggers for action. In other words, you know when and how to respond if accrual is not going as planned.
Literature and Tools (301)
A randomized recruitment intervention trial in Parkinson's disease to increase participant diversity: early stopping for lack of efficacy.
Clin Trials. 2012 Apr. 9. 2. 188-97.
KEYWORDS: Knowledge/Attitudes/Beliefs, Logistics/Transportation, Underserved, Level of Clinical Trials Knowledge or Awareness, Staff Experience Level, Physician Champions, Provider-Patient Relationship, Attitudes, Minority Groups, Verbal Communications, Brochure or Flyer, Non-Cancer
A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials.
Br J Cancer. 2007 Sep 11. 97. 6. 705-11.
KEYWORDS: Knowledge/Attitudes/Beliefs, International, Consent, Brochure or Flyer, Cancer, Treatment
Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study.
Trials. 2012 Dec 10. 13. 237.
KEYWORDS: Eligibility, Men, Minority Groups, Black or African-American, Cancer
Monitor. 2012 Dec. 26. 5. 39-42.
KEYWORDS: Institutional Issues, Regulatory Issues, Web, Social Media
National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial: Advancing the science of recruitment and breast cancer risk assessment in minority communities.
Clin Trials. 2013 Jan 18. [Epub ahead of print]
KEYWORDS: Language or Cultural Barriers, Staff Experience Level, Physician Champions, Women, Minority Groups, American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, Verbal Communications, Radio, TV, Web, Print Media, Brochure or Flyer, Letter, Cancer, Prevention