While much has been learned in the past year about decentralized and virtual trials, industry executives meeting last week at a SCOPE conference emphasized that virtual isn’t always the answer. Read More
Sites and sponsors have shown interest in permanently adopting technologies used during the pandemic to make trials more virtual and accessible to patients, but sponsors must be cognizant of the burdens such solutions can impose on sites and avoid using technology that would bog them down. Read More
From the lessons learned in the COVID-19 pandemic, the FDA intends to push for greater use of master protocols, decentralized trials and digital health technology moving forward, said Acting Commissioner Janet Woodcock. Read More
Sponsors working on developing drugs for rare diseases should increase their efforts to obtain natural history data, which can improve the rigor of their drug development programs and help support clinical trials. Read More
There’s often a rush to form data monitoring committees (DMCs) and get the organizational meeting out of the way as study initiation approaches, but sponsors and sites need to take time to make sure that plans for the group are solid before their work begins. Read More
The COVID-19 crisis showed sites that sponsors and regulatory agencies are capable of moving at unprecedented speed to respond to trial and protocol adaptations. But the pandemic has also revealed some problematic issues, including a growing reliance on technology and service vendors and the siloing of different partners in the trial process. Read More
As the return to normalcy continues in the post-COVID-19 pandemic world, a new state of the industry report shows that most sponsors and CROs intend to continue using innovative measures adopted during the health crisis and believe such approaches are here to stay. Read More
U.S. trials sponsored by industry have a higher completion rate, but remain a smaller part of the trial landscape overall and are also completing trials faster with larger enrollments, says a new analysis. Read More
The University of Oxford and the National Institutes of Health (NIH) are considering launching human challenge trials if enrollment requirements in standard COVID-19 studies can’t be met. Read More
The issues posed by the COVID-19 pandemic have led to a roughly 30 percent increase in site costs, with much of the increase stemming from sites being forced to quickly adopt remote monitoring and other measures in response to the crisis, experts say. Read More