Abstract Despite a wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in clinical trials, local clinics and research sites with access, trust and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. Lloryn Hubbard explores the distinctive outreach and engagement approaches being…
Why the pandemic is a crucible for clinical trial innovation
The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations. To get a clearer sense of what the ramifications of this accelerated development will…
The COVID-19 effect: Research platforms require new capabilities
Like a Category 5 hurricane, COVID-19 has uprooted traditional clinical trial methods to clear space for emerging models and practices to grow and flourish. Three related and complementary trends will have a profound and lasting impact. The shift to virtual/decentralized clinical trials. The popularity of decentralized clinical trials (DCTs) skyrocketed following the nationwide lockdown last March.…