FDA Recommends Clinical Trial Sponsors Consider Virtual Visits
The FDA recently released new guidance on clinical trials in the face of COVID-19. In their published report, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, they acknowledged that challenges may arise in ongoing trials. For...
Hybrid DCTs Reduce Dropout Rates in Long-Term Studies
Clinical studies are carefully designed to address the unique needs of not only the sponsor, but more importantly, the patients that commit to participate. Depending on the nature and severity of the condition, study lengths vary. A cardiovascular outcome trial...
Telemedicine in the Era of Coronavirus Disease
The Coronavirus Disease 2019 (COVID-19) is wreaking havoc around the globe. With a seemingly imminent pandemic on the horizon, healthcare organizations are rushing to prepare for the fallout. The Centers for Disease Control and Prevention warned that it expects the...
Decentralized Clinical Trials Enable Participation for Immobile Patients
Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Consider the additional patient burden involved in clinical trials for patients with paralysis, dementia, or other conditions...