As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring.

The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed.

Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial’s DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report.

It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.

To determine core temperature (Tc) elevations in hazardous materials (HazMat) technicians wearing level-A fully encapsulated, chemically resistive suits (FECRSs) during training scenarios.

Cross-sectional, observational feasibility study with Institutional Review Board approval.

HazMat training scenarios held during the summer of 1994. Weather conditions included both rainy and sunny days, with a mean ambient temperature of 75.8°F(24.3°C) (range 69–83° F [20.6–28.3°C).

Nine male firefighters participating in training scenarios in the Midwestern United States.

Each volunteer swallowed a capsule containing a Tc sensor developed by the National Aeronautics and Space Administration. The capsule continuously monitored Tc and stored data in an ambulatory recorder worn under the level-A FECRS during training.

Mean age of the volunteers was 34 years, mean weight was 92.6 kg, and average baseline Tc was 36.7°C (97.1°F) (range 35.3–38.2°C [95.5–100°F]). Time in the FECRS averaged 25.4 minutes (range 14–35 minutes). All subjects demonstrated increased Tc while in the suit; the mean Tc increase was 0.8°C (1.4°F) (range 0.2–1.3°C [0.4–2.3°F]). The Tc continued to increase during wet decontamination procedures and after suit removal. Mean heat storage values (ΔTcx LBMx 3.47 kJ) were calculated, and found to be moderately elevated to 3.6 kJ/kg (range 2.1–4.6 kJ/kg).

These observations support the validity and significance of implementing prophylactic measures for firefighters using protective clothing. Simple protective measures include enforced time limitations, hydration, and efforts to minimize heat buildup by avoiding both direct sunlight and unnecessary time encapsulated in the suit.