Community-based recruitment for clinical trials poses the need for social and ethical considerations

Ladia, Mary Ann J.; Sison, Olivia T.; Anonuevo, Cora A.; Alejandria, Marissa M.

doi:10.1016/j.jclinepi.2018.06.002

Cited by 3 publications

(4 citation statements)

References 8 publications

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“…However, in our study on the causes of screening failure in healthy subjects in phase I clinical trials, we found that being aged between 18 and 45 years was not correlated with the screening failure rate, but the rate fluctuated among other age groups; being aged 45 years or older was positively associated with a higher screening failure rate. The possible reason for this result is that subjects aged between 18 and 30 years (screening failure rate: 60.58%) may not have fully understood the phase I clinical trial requirements, or relatives prevented their participation, resulting in a large number of withdrawals (23). Additionally, their poor lifestyle habits (sleep, diet) may have led to higher screening failure rates.…”

Section: Influencing Factors Of Screening Failurementioning

confidence: 99%

Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process

Li¹,

Zhang²,

Liu³

et al. 2021

Ann Transl Med

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Section: Influencing Factors Of Screening Failurementioning

confidence: 99%

Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process

Li¹,

Zhang²,

Liu³

et al. 2021

Ann Transl Med

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“…However, there are potential challenges, including the need for school permission and buy-in, distrust on the part of communities toward outside researchers, and bias of enrolling utilizers of health care services. Community-based approaches with local partnerships can help to improve recruitment of vulnerable populations into clinical research (Ladia et al 2018).…”

Section: Discussionmentioning

confidence: 99%

Recruiting Adolescents from Medicaid Enrollment Files into a Neighborhood Oral Health Study

Basson

Yoo

2019

JDR Clinical & Translational Research

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Introduction: Strategies are needed to improve recruitment of low-income adolescents into oral health studies. Objectives: In this study, we assessed the feasibility of recruiting Medicaid-enrolled adolescents into a neighborhood-level oral health study using Medicaid enrollment files and to evaluate the degree of bias in the final recruited study population. Methods: We obtained Medicaid enrollment files from the Oregon Health Authority for 15,440 Medicaid enrollees aged 12 to 17 y from Multnomah, Hood River, and Tillamook counties. We attempted to contact the primary caregiver of each adolescent by telephone, and we tracked contact, recruitment, enrollment, and study completion rates. We further assessed if these rates were different across countylevel rurality, neighborhood-level income, and caregiver-level language preference (Spanish vs. English). The Pearson chi-square test was used to compare rates (α = 0.05). We contacted 6,202 caregivers (40.2%), recruited 738 adolescents (11.9%), enrolled 335 (45.4%), and had complete data for 284 (84.8%). The overall enrollment yield from contacted caregivers was 5.4%. Contact rates did not differ significantly by rurality (P = 0.897), but they were significantly lower in the lowest-income neighborhoods (P = 0.023). Recruitment rates were significantly higher for adolescents from rural counties (P = 0.001), but they did not differ by income or language preference. Enrollment rates were significantly higher among adolescents from rural counties (P < 0.001) and were significantly associated with income (P = 0.041), but they were not different by language preference (P = 0.083). Among participants with complete data, there were no differences by rurality or income, but a significantly larger proportion of adolescents with complete data had caregivers with a language preference for Spanish (P = 0.043). Results and Conclusions: It is feasible to recruit Medicaid-enrolled adolescents into a neighborhood oral health study through the use of Medicaid files. County-, neighborhood-, and caregiver-level factors may influence characteristics of the final study population. Additional research is needed to improve recruitment of Medicaid enrollees into neighborhood oral health studies. Knowledge Transfer Statement: Researchers can use the results of this study to plan neighborhood-level oral health studies involving recruitment of low-income adolescents. Findings further underscore the importance of assessing factors related to recruitment to evaluate participant bias and the generalizability of study findings.

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“…10 We employed RRSF to conduct clinic-based recruitment and phone-based data collection. 25 ENABLE CHF-PC palliative care and HF clinicians, investigators, study staff, and recruitment core staff worked together to develop standardized medical record screening, recruitment, data collection, and training procedures. Training included orientation to the electronic medical record (EMR) systems, the REDCap 26 study database, a brief clinical review of advanced HF, and screening and recruitment procedures to identify eligible participants in the EMR.…”

Section: Methodsmentioning

confidence: 99%

“…10 We employed RRSF to conduct clinic-based recruitment and phone-based data collection. 25 Study staff also developed an UAB/ENABLE CHF-PC branded recruitment folder that included the recruitment script, consent forms, a patient-friendly schema flyer detailing study activities, a study brochure with photo inserts of the study investigators, nurse coaches, and recruiters (Figure 1), survey response sheets for phone-based data collection, and the recruiter's business card. ENABLE CHF-PC participants received $10 incentives for completing each study data point.…”

Section: Recruitment Proceduresmentioning

confidence: 99%

African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial

et al. 2020

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Background: Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge. Objectives: Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs. Methods: This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials. Results: Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; PFDR = .03), were more likely to be single ( P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more “denial” coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores. Conclusion: ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs. Trial Registration: ClinicalTrials.gov Identifier: NCT02505425

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Community-based recruitment for clinical trials poses the need for social and ethical considerations

Cited by 3 publications

References 8 publications

Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process

Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process

Recruiting Adolescents from Medicaid Enrollment Files into a Neighborhood Oral Health Study

African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial

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