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

ABSTRACT:

Background

Catastrophic disruptions in care delivery threaten the operational efficiency and potentially the validity of clinical research efforts, in particular randomized clinical trials. Most recently, the COVID-19 pandemic affected essentially all aspects of care delivery and clinical research conduct. While consensus statements and clinical guidance documents have detailed potential mitigation measures, few real-world experiences detailing clinical trial adaptations to the COVID-19 pandemic exist, particularly among, large, global registrational cardiovascular trials.

Methods

We outline the operational impact of COVID-19 and resultant mitigation measures in the Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure (DELI

SUBMITTER: Bhatt AS 

PROVIDER: S-EPMC10200275 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature