Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.

Background: Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.

Methods: This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT.

COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise.

A key aspect of the National Institutes of Health (NIH) funded Rapid Acceleration of Diagnostics (RADx) Tech program was an active Clinical Studies Core including Committees with unique expertise to facilitate the development and implementation of studies to test novel diagnostic devices for Covid-19. The Ethics and Human Subjects Oversight Team (EHSO) was tasked to provide ethics and regulatory expertise to stakeholders in the RADx Tech effort. The EHSO developed a set of Ethical Principles to guide the overall effort and provided consultation on a wide range of ethical and regulatory concerns.

Finding a Needle in a Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection.

Background: Rapid antigen tests (Ag-RDT) for SARS-CoV-2 with Emergency Use Authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially.

Objective: To describe a novel study design to generate regulatory-quality data to evaluate serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.

Design: Prospective cohort study using a decentralized approach.

The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies.

The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) Tech initiative to support the development and commercialization of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) point-of-care test devices. The primary objective of the Clinical Studies Core (CSC) was to perform SARS-CoV-2 device studies involving diverse populations and settings. Within a few months, the infrastructure for clinical studies was developed, including a master protocol, digital study platform, data management system, single IRB, and multi-site partnerships.

Argument status and PP-attachment.

Prepositional phrase attachment was investigated in temporarily ambiguous sentences. Both attachment site (noun phrase or verb phrase) and argument status (argument or adjunct) were manipulated to test the hypothesis that arguments are processed differently than adjuncts. Contrary to this hypothesis, some previous research suggested that arguments and adjuncts are initially processed in the same manner, following a general bias to attach prepositional phrases to the verb phrase whenever possible [Clifton, Speer, & Abney (1991) Journal of Memory and Language, 30, 251-271].

Differences in the timing of implausibility detection for recipient and instrument prepositional phrases.

We conducted two word-by-word reading experiments to investigate the timing of implausibility detection for recipient and instrument prepositional phrases (PPs). These PPs differ in thematic role, relative frequency, and possibly in argument status. The results showed a difference in the timing of garden path effects such that the detection of implausible dative recipients (which are clearly arguments) was delayed relative to the detection of implausible instruments (which may not be arguments).