UT Health San Antonio offers several distinct electronic tools and resources to facilitate participant recruitmentRecruitmenta pre-enrollment activity used to find potential subjects. .
UT Health SA Find-a-Study is a service provided by the Office of Clinical ResearchClinical Researchthe broad category of biomedical or health outcome research designed to assess pre-defined groups of individuals. for connecting people interested in participating in a research study to investigators with research studies open to enrollmentEnrollmentthe process of seeking eligible participants and obtaining their consent to participate in the research. Enrollment generally starts with recruitment, leading to screening for eligibility, and consent to enroll in the study. .The website allows patients to search for studies or register as a volunteer to be contacted by researchers for general interest or interest in a specific study. Study listings on Find-a-Study will be automatically posted for studies registered with ClinicalTrials.gov, but investigators may opt out of study record display from the Find-a-Study website. Studies not required to register with ClinicalTrials.gov may request a listing on Find-a-Study by completing and submitting IRB Form L-1.
ResearchMatch.org: UT Health SA is a participating institutionInstitutionany public or private entity or agency (including federal, state or other agencies). in ResearchMatch, a free recruitment and feasibility analysis tool for researchers. Individuals who are interested in participating in research studies can create a profile on ResearchMatch with information about their location and health status. Investigators with IRB-approved studies can use the ResearchMatch system to find potential participants who meet their enrollment needs in terms of health conditions and locations, then contact them about participation in a deidentified manner. Investigators can also run deidentified searches to see the approximate number of potential volunteers in the database meeting study criteria for feasibility purposes before obtaining IRB approval. Go to https://www.researchmatch.org/researchers/ for more information.
The Clinical Informatics Research Division (CIRD) is a research and academic division dedicated to improving health care by bridging biomedical, statistical, and computational domains. The CIRD curates a de- identifiedIdentifiedindividual is identified as a prospective subject during recruitment: 1) by obtaining the results of procedures performed as part of the practice of medicine, 2) by responding to recruitment activities, or 3) referred by a provider. data warehouse that is accessible to researchers through multiple software tools such as i2b2, TriNetX, etc., for data query for study feasibility purposes. Additionally, researchers may request collaboration with the CIRD to obtain individual level or identified data for IRB approved research studies.
The EMPaCT Consortium (Enhancing Minority Participation in Clinical Trials), established in 2009, published a number of papers on barriers to minority participation in clinical trials and how to overcome them, including a dedicated supplement issue of the journal Cancer (Enhancing minority participation in clinical trials (EMPaCT): Laying the Groundwork for Improving Minority Clinical TrialClinical Trialone type of Clinical Research that follows a pre-defined plan or protocol. Subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. AccrualAccrualthe process of seeking eligible participants and obtaining their consent to participate in the research. . (2014). Cancer, 120(S7), ii-vii, 1087-1130. doi:10.1002/cncr.30168). The Consortium’s YouTube channel at https://www.youtube.com/user/EMPACTconsortium/featured may also be of interest to researchers seeking to encourage minority enrollment in their studies.
Vanderbilt University also has a free-to-audit course on Coursera titled “Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials.” https://www.coursera.org/learn/recruitment-minorities-clinical-trials.
Identification, initial contact, and recruitment of a potential human subjectHuman Subjecta living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. form the foundation of the informed consentInformed Consenta person's voluntary agreement based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic therapeutic or preventive procedure. process. Both the screeningScreeninga 'pre-enrollment' activity used to determine eligibility. Screening procedures are necessary solely for the purpose of determining eligibility. and the recruitment process should demonstrate and reflect respect for the dignity and autonomyAutonomythe ability of a person to consider alternatives, make choices, and act without undue influence or interference from others. of the potential participants by avoiding any potential undue influenceUndue Influencethe offer of inducements excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. and by protecting both the privacyPrivacycontrol over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. of the individual and the confidentialityConfidentialitypertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission. of any information obtained for recruitment and/or screening purposes. The recruitment plan should reflect elements which demonstrate equitableEquitablefair or just; used in the context of selection of subjects, to indicate that the benefits and burdens of research are fairly distributed. selection of participants, respect for privacy, lack of pressure, an unbiased presentation, and be void of conflicting interests.
Recruitment involves a well thought out plan to maximize recruitment rate through a strategic assessment:
Expected recruitment targets
- Investigator InitiatedInvestigator InitiatedIndicates that the study plan was developed by a local investigator and not from an external entity. Research: How many subjects are needed to answer the research questions?
- Externally Sponsored Research: How many subjects are you contracted to enroll in the study?
Target patient population
- Given the inclusion and exclusion criteria of the study who are the subjects that need to be targeted.
- Age Range
- Barriers to recruitment
- Study related barriers should be limited to reduce the burden on participation. Examples of study related barriers include;
- Inclusion/Exclusion requirements
- The number or frequency of procedures and visits.
- The invasiveness, riskRiska potential harm described in terms of probability (chance) and magnitude (severity). or time commitment of procedures.
- Length of time in which we have to recruit and enroll subjects in the study.
- Projection of the frequency and how many subjects need to be recruited to reach recruitment goal.
- # of Sites
- # of Weeks or Months to Recruit
- Screen Fail Rate, number of subjects to recruit to get 1 enrolledEnrolledscreened participants are enrolled if eligibility is verified (meet all inclusion criteria and none of the exclusion) and they consent to continue in the study. subject.
- Expected attrition rate
- Subjects who start active treatmentActive Treatmentapplicable to interventional study, indicates participant is actively involved with study intervention(s). in the study however do not end up completing participation.
- Lost to Follow-up
Methods to reach target audience
Recruitment performance monitoring