Insights and lessons learned from a prospective clinical pharmacology study in allogeneic hematopoietic stem cell transplant during the COVID-19 pandemic

To develop the first population pharmacokinetic (PopPK) model for oral tacrolimus in adult allogeneic hematopoietic cell transplant (allo-HCT) recipients, we conducted a prospective clinical pharmacology study among real-world patients (NCT04645667). This commentary describes the challenges associated with planning and executing the clinical pharmacology study during the global pandemic, and provides insights on how to effectively communicate, remain adaptable to institutional changes, improve consent rate, and to accommodate new clinical workflows and coronavirus disease 2019 (COVID-19) safety precautions without compromising the scientific integrity of the study.