Adapting Clinical Trial Protocol in Response to COVID-19
Based on recent SCRS survey data, a vast majority of research sites (58%) anticipate that COVID-19 will negatively affect their clinical trial enrollment and nearly half of respondents (47%) feel COVID-19 will have a negative effect on retention. With the number of...
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...