Efforts to improve diversity in research appear to be paying off for Black Americans, but other minorities still aren’t being adequately represented in trials, a new FDA analysis shows. Read More
Industry is approaching a watershed moment, with sponsors and CROs planning for the first time to conduct more hybrid trials than traditional site-based trials, a trend that is expected to play out across all trial phases and therapeutic areas. Read More
If Robert Califf’s nomination to helm the FDA a second time succeeds in Congress, he is likely to push for clinical research reforms, with a focus on diversity, the increased use of real-world evidence (RWE) and addressing the rising costs and complexity of trials. Read More
An overwhelming majority of sponsors felt confident in data collected using remote approaches adopted to keep trials going during the pandemic, a new survey shows, but they also had concerns about added complexities for sites and investigators. Read More
Dedicated research sites and private practices are doing a significantly better job of enrolling diverse patient populations in industry-sponsored trials compared to academic medical centers (AMC) and community hospitals. Read More
As more sponsors and sites use the flexibility offered by eConsent and remote consent, they’re also dealing with some concerns attached to those approaches, especially the documentation that the FDA will ask for during inspections. Read More
After nearly two years of postponed or remote site inspections due to the pandemic, the FDA appears to have returned to normal on its good clinical practice (GCP) inspections and routine surveillance. Read More
While sites and sponsors performed admirably despite the unforeseen challenges of the pandemic, they still grapple with issues that have become more pressing: staffing, enrollment and protocol complexity. Read More
Sponsors and CROs say the industry is still moving too slowly when companies adopt trial innovations because they’re not using unified, enterprisewide approaches when they implement new systems and new trial approaches. Read More
An increase in the number of trials and rising trial complexity was a human resource challenge for sites even before the pandemic hit. When COVID-19 arrived, sites lost staff to patient care, trial shutdowns and uncertainty about the safety of their work. Read More