Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time

Background Increasing the diversity of research participants is an important focus of clinical trials. However, little is known regarding who enrolls as healthy volunteers in Phase I clinical trials, which test the safety and tolerability of investigational new drugs. Despite the risk, healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling. Objective This study’s purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials. Methods The HealthyVOICES Project (HVP) is a longitudinal study of healthy individuals who have enrolled in Phase I trials. We describe self-reported sociodemographic information and Phase I trial history from HVP recruitment (May-December 2013) through the project’s end three years later (December 2016). Trial experiences are presented as medians and quartiles. Results The HVP included 178 participants. Nearly three-fourths of participants were male, and two-thirds were classified as racial and ethnic minorities. We found that some groups of participants were more likely to have completed a greater number of clinical trials over a longer timeframe than others. Those groups included participants who were male, Black, Hispanic, 30-39-years-old, unemployed, had received vocational training in a trade, or had annual household incomes of less than $25,000. Additionally, the greater the number of clinical trials participants had completed, the more likely they were to continue screening for new trials over the course of three years. Participants who pursued clinical trials as a full-time job participated in the greatest number of trials and were the most likely to continuing screening over time. Implications Participation as a healthy volunteer in US Phase I trials is driven by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and participate longer than more privileged groups

Frequency of Care and Mortality Following an Incident Diagnosis of Peripheral Artery Disease in the Inpatient or Outpatient Setting: The ARIC (Atherosclerosis Risk in Communities) Study

Background-—Available health services data for individuals with peripheral artery disease (PAD) are often from studies of those eligible for or undergoing intervention. Knowledge of the frequency of care and mortality following an initial PAD diagnosis by setting (outpatient versus inpatient) is limited and represents an opportunity to provide new benchmark information. Methods and Results-—The purpose of this study was to characterize the frequency of care and mortality following an incident PAD diagnosis in the outpatient or inpatient setting using data from the ARIC (Atherosclerosis Risk in Communities) study cohort linked with Centers for Medicare and Medicaid Services fee-for-service claims data (2002–2012). Direct standardization was used to estimate age-standardized rates of encounters and mortality. PAD was defined by billing code in any claim position. We observed 1086 incident PAD cases (873 outpatient, 213 inpatient). At 1 year after diagnosis, participants diagnosed in the outpatient setting had 2.15 (95% confidence interval [CI], 2.10–2.21) PAD-related outpatient encounters per person-year, and 6.4% (95% CI, 4.8–8.1) had a PAD-related hospitalization. Conversely, participants diagnosed in the inpatient setting had 1.02 (95% CI, 0.94–1.10) PAD-related outpatient encounters per person-year, and 14.2% (95% CI, 9.3–18.7) had a PAD-related rehospitalization. One-year mortality was 7.1% (95% CI, 5.4–8.7) and 16.0% (95% CI, 11.0–21.1) among those diagnosed in outpatient and inpatient settings, respectively. Conclusions-—This study provides important data estimating frequency of care and mortality by the setting of initial PAD diagnosis. Individuals with PAD are frequent users of health care, and those diagnosed in the inpatient setting have high rates of rehospitalization and mortality

Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

Background. The efficacy of messenger RNA (mRNA)-1273 against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is not well defined, particularly among young adults. Methods. Adults aged 18-29 years with no known history of SARS-CoV-2 infection or prior vaccination for coronavirus disease 2019 (COVID-19) were recruited from 44 US sites from 24 March to 13 September 2021 and randomized 1:1 to immediate vaccination (receipt of 2 doses of mRNA-1273 vaccine at months 0 and 1) or the standard of care (receipt of COVID-19 vaccine). Randomized participants were followed up for SARS-CoV-2 infection measured by nasal swab testing and symptomatic COVID-19 measured by nasal swab testing plus symptom assessment and assessed for the primary efficacy outcome. A vaccine-declined observational group was also recruited from 16 June to 8 November 2021 and followed up for SARS-CoV-2 infection as specified for the randomized participants. Results. The study enrolled 1149 in the randomized arms and 311 in the vaccine-declined group and collected >122 000 nasal swab samples. Based on randomized participants, the efficacy of 2 doses of mRNA-1273 vaccine against SARS-CoV-2 infection was 52.6% (95% confidence interval, -14.1% to 80.3%), with the majority of infections due to the Delta variant. Vaccine efficacy against symptomatic COVID-19 was 71.0% (95% confidence interval, -9.5% to 92.3%). Precision was limited owing to curtailed study enrollment and off-study vaccination censoring. The incidence of SARS-CoV-2 infection in the vaccine-declined group was 1.8 times higher than in the standard-of-care group. Conclusions. mRNA-1273 vaccination reduced the incidence of SARS-CoV-2 infection from March to September 2021, but vaccination was only one factor influencing risk. © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.Open access journalThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]