Bringing research directly to families in the era of COVID-19

Balevic, Stephen J.; Singler, Lindsay; Randell, Rachel L.; Chung, RS; Lemmon, Monica E.; Hornik, Christoph P.

doi:10.1038/s41390-020-01260-1

Cited by 7 publications

(3 citation statements)

References 12 publications

(15 reference statements)

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“…We encountered several legal challenges related to conducting in-home clinical trial activities on a national scale. 30 First, we clearly delineated that we were conducting teleresearch, not telemedicine. Although we were studying a device-based intervention, and not a prescribed study drug, participants may nevertheless perceive in-home assessments as diagnosis and treatment.…”

Section: Trial Design and Implementation Considerationsmentioning

confidence: 99%

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial

et al. 2021

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IntroductionDirect-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designing and implementing direct-to-family studies is poorly defined, especially in children with rheumatic disease. This paper provides lessons learnt from the design and implementation of a self-controlled, direct-to-family pilot trial aimed to evaluate the effects of a medication management device on adherence to hydroxychloroquine in paediatric SLE.MethodsSeveral design features accommodate a direct-to-family approach. Participants meeting eligibility criteria from across the USA were identified a priori through a disease registry, and all outcome data are collected remotely. The primary outcome (medication adherence) is evaluated using electronic medication event-monitoring, plasma drug levels, patient questionnaires and pill counts. Secondary and exploratory endpoints include (1) lupus disease activity measured by a remote SLE Disease Activity Index examination and the Systemic Lupus Activity Questionnaire; and (2) hydroxychloroquine pharmacokinetics and pharmacodynamics. Recruitment of the initial target of 20 participants was achieved within 10 days. Due to initial recruitment success, enrolment was increased to 26 participants. Additional participants who were interested were placed on a waiting list in case of dropouts during the study.Discussion and disseminationDirect-to-family trials offer several advantages but present unique challenges. Lessons learnt from the protocol development, design, and implementation of this trial will inform future direct-to-family trials for children and adults with rheumatic diseases. Additionally, the data collected remotely in this trial will provide critical information regarding the accuracy of teleresearch in lupus, the impact of adherence to hydroxychloroquine on disease activity and a pharmacokinetic analysis to inform paediatric-specific dosing of hydroxychloroquine.Trial registration numberClinicalTrials.gov Registry (NCT04358302).

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Section: Trial Design and Implementation Considerationsmentioning

confidence: 99%

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial

et al. 2021

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“…However, the fundamental premise in clinical research of testing the safety and efficacy of therapeutics under controlled conditions has been significantly impacted by the pandemic’s health concerns about congregate settings and ongoing social distancing requirements. In the spring of 2020, public health measures all over the globe (including mandatory lockdowns, institutional guidelines and individual behavior patterns) combined to bring clinical trials virtually to a halt [ 1–5 ]. As of January 2021 there were more than 2000 clinical trials that had been stopped explicitly due to COVID-19 restrictions [ 6 ].…”

Section: Clinical Trial Disruption and Opportunitymentioning

confidence: 99%

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

Anderson¹

2021

Bioanalysis

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Thousands of clinical trials all over the world were stopped, disrupted or delayed while countries grappled to contain the pandemic and research resources were redeployed. The long-term effects of the turbulence caused by the pandemic have yet to be fully understood, but it should already be clear that the increased focus on participant needs and on the logistical challenges of current models are not likely to fade away quickly. This disruption is opening doors for rethinking traditional approaches to clinical trial conduct – including decentralizing site visits, introducing new methods of sample collection, rethinking matrix selection, reducing sample volumes and collaborating on device development. These approaches reduce participant burden while improving critical trial data.

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“…However, as some parents cited a desire to discuss participation with the other parent prior to consenting, this may suggest that the policy is responsible in some way for the decrease in recruitment. Newer methods for research studies including direct-to-family study design, in which recruitment, intervention, and data collection all occur remotely (e.g., in participants’ homes), 12 require additional technology.…”

Section: Children and Familiesmentioning

confidence: 99%