Step 2: Conducting a Cancer Prevention Clinical Trial
Recruiting Participants
A minimum of 75 study participants should be accrued per year within each consortium. Recruitment efforts can be influenced by factors such as the study's eligibility criteria; the patient population seen at individual sites; and the extent of collaboration among medical specialists.
At its most core, recruitment involves:
- Identifying and screening potential participants
- Scheduling initial site visits to assess eligibility of potential participants
Generally, a pool of potential participants becomes significantly smaller as it goes through the processes of eligibility screening, decision-making, and informed consent. Developing and implementing communication strategies that can reach as many prospectively eligible participants as possible becomes necessary to generate a solid volume of study candidates.
DCP's recruitment manual template (pdf, 91kb) gives examples of established recruitment strategies and specifies methods for planning efforts, maintaining accrual goals, handling low literacy, dealing with mental or physical impairments, and reviewing responses to the strategies.
Recruitment also concerns these issues:
- FDA guidance for handling recruitment strategies of clinical trial participants, covers media advertising, payment to research subjects, and screening tests prior to enrollment.
- Recruitment of ethnic and minority populations, including medically underserved populations and women, is required by law. Federal racial and ethnic categories were updated to comply with standards in Office of Management and Budget Directive No. 15.
- For potential participants who ask about whether their health insurance will cover the cost of medical care during participation in a clinical trial, general information is available from NCI.
- National privacy protections prohibit some methods previously used to identify and screen patients for clinical trial eligibility.
