Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches

Loucks, Tammy L.; Tyson, Clare; Dorr, David A.; Garovic, Vesna D.; Hill, James O.; McSwain, S. David; Radovick, Sally; Sonnenberg, Frank A.; Weis, Jennifer A.; Brady, Kathleen T.

doi:10.1017/cts.2021.19

Cited by 38 publications

(44 citation statements)

References 11 publications

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“…To reduce barriers to use, regulatory agencies must align around guidelines for the conduct of video visits and sponsors must commit the necessary funds and personnel support [ 98 ]. We should also build flexibility (e.g., in regard to visit location or method of obtaining informed consent) into our study designs [ 99 ]. Such planned flexibility is more participant-centric and will allow us to much more readily adapt to future unexpected challenges in clinical research conduct.…”

Section: Researchmentioning

confidence: 99%

Moving Forward from the COVID-19 Pandemic: Needed Changes in Movement Disorders Care and Research

Valdovinos

Modica

Schneider

2022

Curr Neurol Neurosci Rep

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Purpose of Review The COVID-19 pandemic has dramatically affected the health and well-being of individuals with movement disorders. This manuscript reviews these effects, discusses pandemic-related changes in clinical care and research, and suggests improvements to care and research models. Recent Findings During the on-going COVID-19 pandemic, individuals with movement disorders have experienced worsening of symptoms, likely due to decreased access to care, loss of social connection, and decreased physical activity. Through telemedicine, care has moved out of the clinic and into the home. Clinical research has also been significantly disrupted, and there has been a shift to decentralized approaches. The pandemic has highlighted disparities in access to care and representation in research. Summary We must now translate these experiences into better care and research models with a focus on equitable integration of telemedicine, better support of patients and caregivers, the development of meaningful digital endpoints, and optimization of decentralized research designs.

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Section: Researchmentioning

confidence: 99%

Moving Forward from the COVID-19 Pandemic: Needed Changes in Movement Disorders Care and Research

Valdovinos

Modica

Schneider

2022

Curr Neurol Neurosci Rep

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“…In the United States, prior to the SARS-CoV-2 pandemic, hybrid models of research have practiced elements of remote data collection; however, fully remote, decentralized studies with remote enrollment and collection of biomedical samples are new to the landscape [ 23 – 25 ]. During the pandemic, clinical trials have faced unprecedented logistical barriers including social distancing protocols, restructuring of clinical sites to accommodate inpatient surges, participants’ fear of potential exposure during study visits, reduction of in-person research staff, and policies deeming study visits non-essential, necessitating adoption of remote methods to sustain research [ 5 , 18 , 26 – 30 ]. Rather than being constrained by these limitations, researchers have capitalized on the need to transform the landscape toward a more equitable and efficient future through implementation of remote study models [ 14 , 17 , 18 , 21 , 31 , 32 ].…”

Section: Introductionmentioning

confidence: 99%

Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study

Naz-McLean

Kim²,

Zimmer³

et al. 2022

PLoS ONE

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Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more representative cohort. As remote trials become more common following the COVID-19 pandemic, a critical evaluation of this approach is imperative to optimize this paradigm shift in research. The TestBoston study was launched to understand prevalence and risk factors for COVID-19 infection in the greater Boston area through a fully remote home-testing model. Participants (adults, within 45 miles of Boston, MA) were recruited remotely from patient registries at Brigham and Women’s Hospital and the general public. Participants were provided with monthly and “on-demand” at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19 via an online dashboard. Between October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18–93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach to recruitment, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Implementation highlighted key differences in remote trial models as participants independently navigate study milestones, requiring a dedicated participant support team and robust technology platforms, to reduce barriers to enrollment, promote retention, and ensure scientific rigor and data quality. Remote clinical trial models offer tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention.

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“…Barriers to participation range from structural factors including required time commitments, distance and transportation to clinical sites, language barriers, and hidden costs, to a legacy of fear and mistrust stemming from historical atrocities in biomedical research (6)(7)(8)(9)(10)(11)(12)(13). Remote models may provide greater efficiency, increased scale, wider geographic catchment areas, and the ability to reach a more representative population, including those unable or unwilling to travel for in-person study visits (5,(14)(15)(16)(17)(18)(19)(20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

“…In the United States, prior to the SARS-CoV-2 pandemic, hybrid models of research have practiced elements of remote data collection; however, fully remote, decentralized studies with remote enrollment and collection of biomedical samples are new to the landscape (23)(24)(25). During the pandemic, clinical trials have faced unprecedented logistical barriers including social distancing protocols, restructuring of clinical sites to accommodate inpatient surges, participants' fear of potential exposure during study visits, reduction of in-person research staff, and policies deeming study visits non-essential, necessitating adoption of remote methods to sustain research (5,18,(26)(27)(28)(29)(30). Rather than being constrained by these limitations, researchers have capitalized on the need to transform the landscape toward a more equitable and efficient future through implementation of remote study models (14,17,18,21,31,32).…”

Section: Introductionmentioning

confidence: 99%

“…During the pandemic, clinical trials have faced unprecedented logistical barriers including social distancing protocols, restructuring of clinical sites to accommodate inpatient surges, participants' fear of potential exposure during study visits, reduction of in-person research staff, and policies deeming study visits non-essential, necessitating adoption of remote methods to sustain research (5,18,(26)(27)(28)(29)(30). Rather than being constrained by these limitations, researchers have capitalized on the need to transform the landscape toward a more equitable and efficient future through implementation of remote study models (14,17,18,21,31,32). However, to date, there is minimal experience in defining best practices in this domain.…”

Section: Introductionmentioning

confidence: 99%

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Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study

Naz-McLean

Kim

Zimmer

et al. 2021

Preprint

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ImportanceRemote clinical trials may reduce barriers to research engagement resulting in more representative samples. A critical evaluation of this approach is imperative to optimize this paradigm shift in research.ObjectiveTo assess design and implementation factors required to maximize enrollment and retention in a fully remote, longitudinal COVID-19 testing study.DesignFully remote longitudinal study launched in October 2020 and ongoing; Study data reported through July 2021.SettingBrigham and Women’s Hospital, Boston MAParticipantsAdults, 18 years or older, within 45 miles of Boston, MA.InterventionMonthly and “on-demand” at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19.Main OutcomesEnrollment, retention, and lessons learned.ResultsBetween October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18-93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Considerable infrastructure, including a dedicated participant support team and robust technology platforms was required to reduce barriers to enrollment, promote retention, ensure scientific rigor, improve data quality, and enable an adaptive study design to increase real-world accessibility.ConclusionsThe decentralization of clinical trials through remote models offers tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Our model highlights the critical role that hospital-community partnerships play in remote recruitment, and the work still needed to ensure representative enrollment. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention.Trial RegistrationN/AKey PointsQuestionLongitudinal clinical studies typically rely on in-person interactions to support recruitment, retention, and implementation. We define factors that promote demographically representative recruitment and retention through implementation of a fully remote COVID-19 study.FindingsRemote trial models can reduce barriers to research participation and engage representative cohorts. Recruitment was strengthened by leveraging the medical system. Implementation highlighted participant burdens unique to this model, underscoring the need for a significant participant support team, robust technological infrastructure, and an adaptive, iterative approach.MeaningAs remote trials become more common following the COVID-19 pandemic, methodologies to ensure accessibility, representation, and efficiency are crucial.

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Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches

Abstract: This version may be subject to change during the production process.

Cited by 38 publications

References 11 publications

Moving Forward from the COVID-19 Pandemic: Needed Changes in Movement Disorders Care and Research

Moving Forward from the COVID-19 Pandemic: Needed Changes in Movement Disorders Care and Research

Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study

Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study

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