Operational challenges and mitigation measures during the COVID-19 pandemic-Lessons from DELIVER

Area of Science:

• Cardiology
• Clinical Research
• Epidemiology

Background:

• Clinical trials face disruptions from events like the COVID-19 pandemic, impacting operational efficiency and data validity.
• While mitigation strategies exist, real-world adaptations in large, global cardiovascular trials remain under-documented.

Purpose of the Study:

• To detail the operational impact of COVID-19 on the Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial.
• To outline mitigation measures and adaptations implemented to ensure participant safety and trial integrity.

Main Methods:

• Described coordination between investigators, leadership, sites, and sponsors for pandemic response.
• Addressed logistical challenges including medication delivery, visit adaptations, and endpoint adjudication.
• Revised protocols and statistical analysis plans to account for COVID-19's impact.

Main Results:

• The DELIVER trial, a large global cardiovascular study, successfully navigated COVID-19 disruptions.
• Implemented measures maintained participant safety and trial operational fidelity.
• Adapted statistical plans allowed for evaluation of pandemic effects on participants.

Conclusions:

• The DELIVER trial's experience provides valuable insights for managing large cardiovascular clinical trials during global health crises.
• Findings can inform prospective contingency planning for future clinical research endeavors.