Enhancing asthma research and improving health equity through decentralized clinical trials (DCTs) and mHealth technology.

The COVID-19 pandemic led to widespread disruption and termination of clinical research and a prompt adoption of mobile health (mHealth) technologies in the healthcare space. As the United States' healthcare system has rapidly become reliant on remotely conducted activities, the implementation of decentralized methods using mHealth technology in research investigation has become a necessary alternative to traditional in-person cohort studies. The aim of this article is to: report successful and unsuccessful examples of remote asthma clinical studies, explore the benefits and potential drawbacks of virtual clinical investigation, discuss the potential impact on equity and representation in asthma research, and provide suggestions through which investigators can implement decentralized clinical trials. Enhanced study accessibility, participant diversity, safety measures, and research efficacy are some of the benefits identified with a focused discussion on the impact on equity that decentralized clinical trials renders. Furthermore, potential concerns regarding regulatory compliance, data privacy, and effective mHealth design and solutions are discussed. Despite the setbacks and interruptions faced by the study participants and investigators due to the pandemic, the transition to decentralized clinical studies using mHealth technology is a positive, feasible step toward innovation and equity in the allergy and immunology field.

Diversity and Representation Among United States Participants in Amgen Clinical Trials.

OBJECTIVE: Describe the demographic profile of US participants in Amgen clinical trials over a 10-year period and variations across therapeutic areas, indications, and geographies. METHODS: Cross-sectional retrospective study including participants enrolled (2005-2020) in phase 1-3 trials completed between January 1, 2012 and June 30, 2021. RESULTS: Among 31,619 participants enrolled across 258 trials, one-fifth represented racial minority populations (Asian, 3%; Black or African American, 17%; American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, each < 1%); fewer than one-fifth (16%) represented an ethnic minority population (Hispanic or Latino). Compared with census data, representation of racial and ethnic groups varied across US states. Across most therapeutic areas (bone, cardiovascular, hematology/oncology, inflammation, metabolic disorders, neuroscience) except nephrology, participants were predominantly White (72-81%). A similar proportion of males and females were enrolled between 2005 and 2016; male representation was disproportionately higher than female between 2016 and 2020. Across most medical indications, the majority of participants were 18-65 years of age. CONCLUSIONS AND RELEVANCE: While the clinical research community is striving to achieve diversity and proportional representation across clinical trials, certain populations remain underrepresented. Our data provide a baseline assessment of the diversity and representation of US participants in Amgen-sponsored clinical trials and add to a growing body of evidence on the importance of diversity in clinical research. These data provide a foundation for strategies aimed at supporting more equitable and representative research, and a baseline from which to assess the impact of future strategies to advance health equity.

Tackling a Major Deficiency of Diversity in Alzheimer's Disease Therapeutic Trials: An CTAD Task Force Report.

As the last opportunity to assess treatment effect modification in a controlled setting prior to formal approval, clinical trials are a critical tool for understanding the safety and efficacy of new treatments in diverse populations. Recruitment of diverse participants in Alzheimer's Disease (AD) clinical trials are therefore essential to increase the generalizability of study results, with diversity broadly described to be representative and inclusive. This representation of study participants is equally critical in longitudinal cohort (observational) studies, which will be key to understanding disease disparities and are often used to design adequately powered AD clinical trials. New and innovative recruitment initiatives and enhanced infrastructure facilitate increased participant diversity in AD clinical studies.

A landscape analysis of HIV cure-related clinical research in 2019.

OBJECTIVES: In 2018, we surveyed investigators conducting HIV cure-related clinical research, drawing on information from the online listing established by Treatment Action Group (TAG). The purpose of the survey was to facilitate a landscape analysis of the field. In 2019, we fielded a second survey in order to provide updated information and assess any shifts in the landscape. METHODS: Trials and observational studies listed as of August 16, 2019 formed the sample set. Survey questions addressed funding, trial development, recruitment, enrollment, participant demographics, antiretroviral therapy status, HIV reservoir assays, invasive procedures, study completion, data sharing and dissemination plans. A survey was sent to the contact(s) for each study. Supplemental information was collected from clinicaltrials.gov and available presentations/publications of study results. RESULTS: A total of 97 interventional trials and 36 observational studies were identified, with 30 including analytical treatment interruptions. Total projected enrollment is 13,732 participants, with observational studies contributing the majority (8,325). Most interventional trials are in early phases. The majority of current research is located in the USA, involves predominately male participants and is limited in racial and ethnic diversity. Prespecified demographic enrollment targets are rare. Two thirds of respondents to our previous survey reported that enrollment is progressing more slowly than anticipated. CONCLUSIONS: A diverse range of interventions are being evaluated in HIV cure research, but participant diversity is far from optimal with a continuing underrepresentation of women. Broadening inclusion and geographic reach will be necessary to achieve the goal of developing widely effective, safe and accessible curative interventions.

Examining Demographics in Randomized Controlled Trials of Group-Based Social Skills Interventions for Individuals with Autism Spectrum Disorder.

We reviewed the demographic reporting practices and diversity of participants in published randomized controlled trial studies of group-based social skills interventions (GSSIs) for individuals with autism spectrum disorder (ASD). A total of 17 studies met inclusionary criteria. Results of this review suggest that the majority of published RCTs reported on participant gender and race/ethnicity, with fewer studies including details on household income and caregiver education. Study samples generally lacked diversity, with an overrepresentation of participants who were male, White, and from upper-middle class backgrounds. Additionally, we found that nearly all GSSI studies focused on participants with average or high IQs, or were specifically classified as having a higher functioning sub-diagnosis within ASD. Implications and future directions for research are discussed.

A landscape analysis of HIV cure-related clinical trials and observational studies in 2018.

OBJECTIVES: The community-based organisation Treatment Action Group has established an online listing of HIV cure-related trials and observational studies derived from trial registries. Our objective was to use the listing as a basis for a landscape analysis of the current status of HIV cure-related clinical research. METHODS: Trials and observational studies listed as of August 2018 formed the sample set. Survey questions were developed on trial development, trial design, recruitment, enrolment, study completion and dissemination plans. A survey was sent to the contact(s) for each study. Supplemental information was collected from clinicaltrials.gov. The full dataset was then analysed. RESULTS: A total of 99 interventional trials and 29 observational studies were included. Diverse interventions are under evaluation, including combinations of experimental candidates. Current studies plan to enrol over 7000 participants. Projected completion dates for ~90% of the sample fell between the fourth quarter of 2018 and the end of 2020. Potential obstacles to enrolment that were reported included concerns over invasive procedures and lack of potential benefit to participants. Data on the sex and ethnicity of enrollees were limited but sufficient to note a significant under-representation of women. CONCLUSIONS: A considerable amount of HIV cure-related clinical research is under way. The results from these studies, which should help shape the future of the field, will become available over the next 2-4 years. Diversity both geographically and in terms of enrollees remains limited, particularly in terms of the participation of women, a concern that could significantly affect the generalisability of the findings.