From crisis to opportunity in a big data study: barriers and facilitators in a national web-based COVID-19 surveillance study.

Context: In March 2020 a COVID-19 Community Research Partnership (CRP) surveillance study was launched. We describe the barriers and facilitators to recruitment and retention during enrollment of >12,000 participants. Objective: To describe the barriers and facilitators to recruitment and retention while collecting daily syndromic and serologic data in a virtual setting. Methods: Key communication strategies designed to proactively enhance participation and retention were: Set up of a study call center; FAQs were emailed to participants and placed on the study webpage; preemptive messaging for getting started after enrollment, updating addresses, and in-home testing were designed; Later setup of a central call center for National team; design and implementation of national messaging for large scale in-home serological testing. Setting and Participants: Healthcare System linked to Six other National study sites. Healthcare system employees and patients, North Carolina residents and bordering counties. Atrium enrolled >12,000 participants, with over 65,000 participants enrolled nationally. Results: Key barriers: missing email communications, incorrectly entered participant information, participant fatigue due to longevity of study, use and return of serology kits. Facilitators: developing appropriate tailored messaging, preemptive communication for pending and failed validations, and development of "Unsubscribe" or "Paused" statuses. Proactive strategies kept the "Pending" enrollment below 10% and "Failed Validation" below 1% of total enrollees. The "Unsubscribe" option allowed withdraw rates to stay below 1% while the unsubscribe rate stayed below 10%. Tailored messaging supported the return of ~79% of test kits with ~43% of missing kits recovered. Conclusions: Large participant enrollment and data accrual resulted in the need for creative approaches to trouble shooting "big data" challenges associated with the rapid start-up of a high enrolling COVID -19 surveillance study. Preemptive messaging and anticipating participants' needs enhanced enrollment, participation and retention.

Ex vivo efficacy of BCMA-bispecific antibody TNB-383B in relapsed/refractory multiple myeloma.

TNB-383B is a fully human BCMA-targeting T-cell engaging bispecific monoclonal antibody (T-BsAb). We assessed ex vivo efficacy of this drug to mediate killing of bone marrow mononuclear cells (BMMCs) freshly isolated from 10 patients with relapsed multiple myeloma (MM). BMMC were treated ex vivo with TNB-383B at doses ranging from 0.001-1 µg. Plasma cell (PC) lysis, viability, BCMA expression, CTL distribution, and degranulation were assessed by flow cytometry. Cytokine response to TNB-383B was quantified by multiplex protein assay. Dose-dependent PC lysis was triggered in all cases by TNB-383B at doses as low as 0.001 µg (P = .0102). Primary MM cells varied in BCMA expression. High BCMA+ PC count correlated with increased PC lysis (P = .005) and significant CTL degranulation specific to TNB-383B treatment (P = .0153 at 1 µg). High E:T ratio in bone marrow specimens led to lower viable and higher apoptotic PC compared with low E:T ratio (P < .001). Three cytokines were significantly modulated by TNB-383B: IL-2/TNFα increased by ∼4 ± 3.5-fold average (P < .005 at 1 µg) and IP10 increased by ∼50 ± 15-fold (P < .001 at 1 µg). We conclude that TNB-383B triggers primary PC lysis and CTL degranulation in a dose-dependent fashion ex vivo with no T cell expansion and mild increase of CRS-associated cytokines.