Abstract
BackgroundThere are a number of obstacles which may impede the recruitment of underserved populations in clinical research studies; some of these factors include mistrust of medical research, socioeconomic constraints, cultural factors, and language barriers. For chronic metabolic disease indications, these barriers may also include lack of disease awareness. Recently, national organizations such as the American Diabetes Association (ADA) and Centers for Disease Control and Prevention (CDC) have highlighted the need for prediabetes recognition. Therefore the aim of the study was twofold: to raise prediabetes awareness in an under-represented Hispanic community and to engage prediabetes participants in clinical research.MethodsHemoglobin A1c (HbA1c) screening was performed at major outreach events catered to the Hispanic community. All participants signed an ethics review board approved waiver which collected basic demographic information and the HbA1c test was performed with a hand-held monitor and finger-stick blood sample. Participants were given their HbA1c results at the event as well as information on prediabetes and upcoming clinic studies. After the event, participants were contacted by a study participant recruiter to assess interest in participating in clinical research.ResultsThe majority of participants screened fell within a prediabetes HbA1c range. Mean HbA1c was similar among men and women, yet higher in individuals aged 45–65 years compared to adults aged < 45 years (p < 0.05). For recruitment purposes, the highest number of leads came from participants attending a faith-based community event. In all, 17% of individuals contacted expressed interest in participating in clinical research and created a profile within our database to be eligible for future studies.ConclusionsProviding no-cost HbA1c screening is an excellent recruitment tool for clinical research as well as an opportunity to raise prediabetes awareness in a traditionally underserved population.
Highlights
There are a number of obstacles which may impede the recruitment of underserved populations in clinical research studies; some of these factors include mistrust of medical research, socioeconomic constraints, cultural factors, and language barriers
The Food and Drug Administration (FDA) encourages pharmaceutical and biotech companies to enroll participants in clinical trials that are representative of individuals who will likely benefit from the therapeutic drug once approved by the agency
To increase prediabetes and type 2 diabetes awareness in a traditionally underserved community, we provided free hemoglobin A1c (HbA1c) screening
Summary
There are a number of obstacles which may impede the recruitment of underserved populations in clinical research studies; some of these factors include mistrust of medical research, socioeconomic constraints, cultural factors, and language barriers. For chronic metabolic disease indications, these barriers may include lack of disease awareness. National organizations such as the American Diabetes Association (ADA) and Centers for Disease Control and Prevention (CDC) have highlighted the need for prediabetes recognition. For chronic metabolic disease indications such as type 2 diabetes, this patient population may include individuals with diabetes risk factors such as obesity and prediabetes. While in the US racial and ethnic minorities comprise roughly 40% of the population [4], the number of disparate individuals enrolling in clinical trials is incredibly low [5]. In 2012 it was reported that minority participation rates in industry-led clinical studies was estimated to be relatively low at 16.7% [9]
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