The CHIEF-HF trial examined the effect of canagliflozin on symptoms and quality of life for patients with heart failure. The trial was conducted completely remotely because of the COVID-19 pandemic and thus offers lessons about remote strategies in future clinical trials.
Mohamed Bassyouni, PharmD Product Development Program Leader Bill and Melinda Gates Medical Research Institute Cambridge, MA
Jintanat Ananworanich, MD, PhD Clinical Development Leader Bill and Melinda Gates Medical Research Institute Cambridge, MA
Topic
Lessons Learned from the Gates MRI Virtual COVID-19 Trial
Keywords
COVID-19; Virtual trial; Gates Medical Research Institute (MRI); Underserved populations; Health outcomes; Treatment safety and efficacy; Decentralized trial
Key Points
The goal of this study was to conduct a randomized controlled, adaptive platform trial to evaluate safety and efficacy of interventions for high-risk people with mild COVID-19 disease.
A key feature of the virtual trial was the development of a “COVID trial in a box.” This innovative method involved a single shipment of the study materials—including the study drug, lab sample kits, pulse oximeter, and PPE—directly to study participants’ homes.
The study evaluated multiple strategies for participant identification and outreach. Challenges included finding a better approach to engage minority communities; having better access for potential participants to be screened for COVID-19; increasing participation in the elderly population.
Discussion Themes
100% remote trials are possible and are especially crucial during a pandemic.
How did the study use social medial for virtual screening?
Did you do exit interviews with participants to get feedback on outreach and study design?
Were alternatives to eConsent offered to patients who may have had technical difficulty with electronic apps or platforms?
