Evaluate the trial for recruitment feasibility
Determine the availability of the study population at your institution and nationally
- Review incidence and prevalence data nationally and in your institution's catchment area.
- Query your institution's data systems to determine the number of potentially eligible participants.
- Assess how proposed inclusion/exclusion criteria will affect recruitment. Overly restrictive eligibility criteria are a well-documented recruitment barrier.
- You may be able to identify criteria that can be broadened without sacrificing the outcome—such as allowing some co-morbid conditions or expanding an age requirement.
Assess and minimize the study burden on patients
- View the trial through a participant’s eyes. How “burdensome” is the research? Consider such questions as: “How much time away from home is required?”, “How many blood draws?”, and “What protocol costs are not covered by insurance?” Perhaps you can identify and eliminate some procedures that are not essential to the study outcome. AccrualNet™ encourages study sites to consider these questions when Selecting and Preparing to Open a Trial. So, potential sites will be thinking about participant burden, too.
Use feasibility studies to test recruitment strategies
- A feasibility study compiles quantitative and qualitative data to illuminate issues that can affect recruitment. Such studies are of particular use for larger Phase III trials. They ask many of the same questions AccrualNet™ does—for example, questions about patient populations as well as the interest levels and capacity at potential study sites. Research teams use feasibility study findings to guide choices related to study design and site selection that aid the recruitment potential of the study.
Literature and Tools (124)
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
Accuracy of geographically targeted internet advertisements on Google AdWords for recruitment in a randomized trial.
J Med Internet Res. 2012 Jun. 14. 3. e84.
KEYWORDS: International, Web, Non-Cancer
Trials. 2012 Nov 21. 13. 1. 218. 2012 Nov 21. [Epub ahead of print]
KEYWORDS: Knowledge/Attitudes/Beliefs, Language or Cultural Barriers, Logistics/Transportation, Low Literacy, Non-English Speaking, Cost/Insurance, Remuneration, Incentives, Staff Experience Level, Physician Champions, Provider-Patient Relationship, International, Institutional Issues, Inadequate Staffing, Eligibility, Placebo, Study Burden, Financial Incentives, Non-Cancer, Cancer
Patient advocates' role in clinical trials: Perspectives from Cancer and Leukemia Group B investigators and advocates.
Cancer. 2012 Oct 01. 118. 19. 4801-5.
KEYWORDS: Knowledge/Attitudes/Beliefs, Attitudes, Consent, Verbal Communications, Cancer
Appl Clin Trials Online. 2012 Oct 05. 6 pages.
KEYWORDS: Logistics/Transportation, Level of Clinical Trials Knowledge or Awareness, Staff Experience Level, Provider-Patient Relationship, Institutional Issues, Eligibility, Cancer