Dataset Information

Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis.

ABSTRACT:

Objective

Competition among trials for patient enrollment can impede recruitment. We hypothesized that this occurred early in the COVID-19 pandemic, when an unprecedented number of clinical trials were launched. We performed a simple and multivariable regression analysis evaluating the relationship between the proportion of SARS-CoV-2 investigational trial sites within each USA state with unsuccessful patient-participant recruitment and: (i) the proportion of cases required to reach state recruitment goals; (ii) state population based on data from the US Census; and, (iii) number of trial sites per state.

Results

Our study included 151 clinical trials. The proportion of trials with successful recruitment was 72.19% (109 of 151 trials). We did not find a significant relationship between unsuccessful patient-participant recruitment, state recruitment goals, state population or the number of trial sites per state in both our simple and multivariable regression analyses. Our results do not suggest that early in the COVID-19 pandemic, competition for patient-participants impeded successful recruitment in SARS-CoV-2 trials. This may reflect the unique circumstances of the first few months of the pandemic in the United States, in which the number and location of SARS-CoV-2 cases was sufficient to meet trial recruitment requirements, despite the large number of trials launched.

SUBMITTER: Hutchinson N

PROVIDER: S-EPMC9742655 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis.

Hutchinson Nora N Klas Katarzyna K Carlisle Benjamin G BG Polak Maciej M Kimmelman Jonathan J Waligora Marcin M

BMC research notes 20221212 1

<h4>Objective</h4>Competition among trials for patient enrollment can impede recruitment. We hypothesized that this occurred early in the COVID-19 pandemic, when an unprecedented number of clinical trials were launched. We performed a simple and multivariable regression analysis evaluating the relationship between the proportion of SARS-CoV-2 investigational trial sites within each USA state with unsuccessful patient-participant recruitment and: (i) the proportion of cases required to reach stat ...[more]

PMID: 36510308

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Project description:BackgroundEarly in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic.MethodsBased on prespecified eligibility criteria, we created a cohort of Phase 1/2, Phase 2, Phase 2/3 and Phase 3 SARS-CoV-2 treatment and prevention efficacy trials that were initiated from 2020-01-01 to 2020-06-30 using ClinicalTrials.gov registration records. We excluded trials evaluating behavioural interventions and natural products, which are not regulated by the U.S. Food and Drug Administration (FDA). We evaluated trials on 3 criteria of informativeness: potential redundancy (comparing trial phase, type, patient-participant characteristics, treatment regimen, comparator arms and primary outcome), trials design (according to the recommendations set-out in the May 2020 FDA guidance document on SARS-CoV-2 treatment and prevention trials) and feasibility of patient-participant recruitment (based on timeliness and success of recruitment).ResultsWe included all 500 eligible trials in our cohort, 58% of which were Phase 2 and 84.8% were directed towards the treatment of SARS-CoV-2. Close to one third of trials met all three criteria and were deemed informative (29.9% (95% Confidence Interval 23.7-36.9)). The proportion of potentially redundant trials in our cohort was 4.1%. Over half of the trials in our cohort (56.2%) did not meet our criteria for high quality trial design. The proportion of trials with infeasible patient-participant recruitment was 22.6%.ConclusionsLess than one third of COVID-19 trials registered on ClinicalTrials.gov during the first six months met all three criteria for informativeness. Shortcomings in trial design, recruitment feasibility and redundancy reflect longstanding weaknesses in the clinical research enterprise that were likely amplified by the exceptional circumstances of a pandemic.

Project description:In order to understand preferences about SARS-CoV-2 testing, we conducted a discrete choice experiment among 4793 participants in the Communities, Households, and SARS-CoV-2 Epidemiology (CHASING COVID) Cohort Study from July 30-September 8, 2020. We used latent class analysis to identify distinct patterns of preferences related to testing and conducted a simulation to predict testing uptake if additional testing scenarios were offered. Five distinct patterns of SARS-CoV-2 testing emerged. "Comprehensive testers" (18.9%) ranked specimen type as most important and favored less invasive specimen types, with saliva most preferred, and also ranked venue and result turnaround time as highly important, with preferences for home testing and fast result turnaround time. "Fast track testers" (26.0%) ranked result turnaround time as most important and favored immediate and same day turnaround time. "Dual testers" (18.5%) ranked test type as most important and preferred both antibody and viral tests. "Non-invasive dual testers" (33.0%) ranked specimen type and test type as similarly most important, preferring cheek swab specimen type and both antibody and viral tests. "Home testers" (3.6%) ranked venue as most important and favored home-based testing. By offering less invasive (saliva specimen type), dual testing (both viral and antibody tests), and at home testing scenarios in addition to standard testing scenarios, simulation models predicted that testing uptake would increase from 81.7% to 98.1%. We identified substantial differences in preferences for SARS-CoV-2 testing and found that offering additional testing options, which consider this heterogeneity, would likely increase testing uptake.SignificanceDuring the COVID-19 pandemic, diagnostic testing has allowed for early detection of cases and implementation of measures to reduce community transmission of SARS-CoV-2 infection. Understanding individuals' preferences about testing and the service models that deliver tests are relevant in efforts to increase and sustain uptake of SARS-CoV-2 testing, which, despite vaccine availability, will be required for the foreseeable future. We identified substantial differences in preferences for SARS-CoV-2 testing in a discrete choice experiment among a large national cohort of adults in the US. Offering additional testing options that account for or anticipate this heterogeneity in preferences (e.g., both viral and antibody tests, at home testing), would likely increase testing uptake.ClassificationBiological Sciences (major); Psychological and Cognitive Sciences (minor).

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Dataset Information

Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis.

Objective

Results

Publications

Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis.

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