TABLE 7.

General considerations on investigational products when performing a non‐COVID‐19–related clinical trial during the COVID‐19 pandemic

Treatment initiation and dose increases only performed in clinic; levels maintained at a stable dosage (eg, for oral immunotherapy) when clinic visits not possible

Training of at‐home administration of biologics and injectables, where applicable 9

Ensuring participants maintain adequate IP supply to continue at‐home dosing as needed without disclosing identity via research pharmacy (direct‐to‐participant shipments or curbside dispensing)

Ensuring integrity between pharmacy and participant in the case of shipping (secure chain of custody and monitoring of storage conditions in transit)

Necessary rescue medication provision with written instructions and emergency phone numbers