Background: The mismatch between the limited availability versus the high demand of participants who are in the pre-dementia phase of Alzheimer's disease (AD) is a bottleneck for clinical studies in AD. Nevertheless, potential enrollment barriers in the pre-dementia population are relatively under-reported. In a large European longitudinal biomarker study (the AMYPAD-PNHS), we investigated main enrollment barriers in individuals with no or mild symptoms recruited from research and clinical parent cohorts (PCs) of ongoing observational studies.
Methods: Logistic regression was used to predict study refusal based on sex, age, education, global cognition (MMSE), family history of dementia, and number of prior study visits. Study refusal rates and categorized enrollment barriers were compared between PCs using chi-squared tests.
Results: 535/1856 (28.8%) of the participants recruited from ongoing studies declined participation in the AMYPAD-PNHS. Only for participants recruited from clinical PCs (n = 243), a higher MMSE-score (β = - 0.22, OR = 0.80, p < .05), more prior study visits (β = - 0.93, OR = 0.40, p < .001), and positive family history of dementia (β = 2.08, OR = 8.02, p < .01) resulted in lower odds on study refusal. General study burden was the main enrollment barrier (36.1%), followed by amyloid-PET related burden (PC = 27.4%, PC = 9.0%, X = 10.56, p = .001), and loss of research interest (PC = 46.3%, PC = 16.5%, X = 32.34, p < .001).
Conclusions: The enrollment rate for the AMYPAD-PNHS was relatively high, suggesting an advantage of recruitment via ongoing studies. In this observational cohort, study burden reduction and tailored strategies may potentially improve participant enrollment into trial readiness cohorts such as for phase-3 early anti-amyloid intervention trials. The AMYPAD-PNHS (EudraCT: 2018-002277-22) was approved by the ethical review board of the VU Medical Center (VUmc) as the Sponsor site and in every affiliated site.
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http://dx.doi.org/10.1186/s13195-023-01332-4 | DOI Listing |
Ann Surg Open
December 2024
Division of Palliative Medicine, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.
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Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA.
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Enrolling adequate numbers of patients into the control arm of randomized controlled trials (RCTs) often presents barriers. There is interest in leveraging real-world data (RWD) from electronic health records (EHRs) to construct external control (EC) arms to supplement RCT control arms and form hybrid control (HC) arms. This investigation showed the use of an HC arm in second-line metastatic pancreatic ductal adenocarcinoma (PDAC).
View Article and Find Full Text PDFDev Neurorehabil
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Alberta Children's Hospital Research Institute, Calgary, AB, Canada.
Participant recruitment for studies investigating neurodevelopmental conditions can be difficult, limited, and resource intensive. In this study, caregivers were surveyed to learn about the factors influencing their decision to enroll their neurodivergent child in research. Data were collected through an online survey from caregivers of neurodivergent children who were signing up for a research recruitment database (n = 46).
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