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ENABLING REMOTE RESEARCH THROUGH DECENTRALIZED RANDOMIZED CONTROLLED CLINICAL TRIALS
Journal of General Internal Medicine ; 37:S267, 2022.
Article in English | EMBASE | ID: covidwho-1995599
ABSTRACT

BACKGROUND:

Traditionally, randomized clinical trials have relied on physical research centers to support subject recruitment and participation. The COVID-19 pandemic has highlighted the need to interact with subjects who are unable to physically visit research centers. By leveraging remote technology, such clinical trials may reach subjects in isolation and broaden geographical reach. We describe a fully remote, multisite randomized controlled clinical trial of outpatient COVID-19 treatments using a technologyenabled, decentralized approach.

METHODS:

We conducted a remote double-blind, randomized placebocontrolled trial (COVID-OUT). We identified subjects through medical records, patient advocacy groups, testing facilities, and multiformat advertising. They were recruited via brochure, electronic message, telephone outreach, and self-referral. Research staff across sites used the Research Electronic Data Capture (REDCap) system to manage local and central enrollment and were reallocated dynamically based on trial needs. Subjects were screened by phone, consented and randomized electronically and delivered study medication by courier or same-day mail. They were followed via their preferred communication method (phone, video, text, or email) to determine the study endpoints.

RESULTS:

1195 non-hospitalized adults aged 30-85 years with laboratory confirmed infection with SARS-CoV-2 were enrolled into the COVID-OUT trial through January 6, 2022 over a span of 7 months. Initially starting as a 2- arm trial with 7 sites, the study expanded to a 6-arm trial with recruitment at 8 sites. To date, 9600 subjects have been screened with an enrollment rate of 12% from 822 zip codes. 25 research coordinators are involved across 8 sites, and the rate of study completion is 90%.

CONCLUSIONS:

Decentralized remote studies offer an efficient, low-touch way of performing research in the COVID-19 era. Our decentralized study design enables research with infectious, isolated subjects in widespread geographies, while maintaining safety of subjects, the research team, and public atlarge. Coordination across sites via RED Cap enabled programmatic efficiencies, including the ability to redistribute staffing support across enrollment sites for study drug distribution, follow-up calls, recruitment, and event reporting. We decreased overall costs by less need for physical research space. The decentralized infrastructure enabled nimble adaptations of the protocol, including increasing follow-up periods to assess long-COVID symptoms and adding study arms for additional outpatient treatments. Given the widespread availability of mobile phones and remote communication, decentralized trials show promise for improving reach and efficiency in both pandemic and nonpandemic times.
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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Journal of General Internal Medicine Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Journal of General Internal Medicine Year: 2022 Document Type: Article