Quality metrics and their role as part of an overall quality management system (QMS) are an important component of clinical research, but not all sites use quality performance tracking tools to their maximum advantage: tracking quality performance and identifying areas for improvement. Academic and institutional researchers haven’t fully embraced the concept of taking methodical steps to examine operations across individual studies. Read More
The coronavirus pandemic has highlighted the effectiveness of large, multisite clinical trials run under master protocols, especially when it comes to evaluating multiple experimental treatment options simultaneously. Despite their advantages, there are some challenges and costs associated with running master protocol trials that the industry is still grappling with. Read More
There is an increasing effort in the industry to mesh clinical trials with clinical care and the line between the two must be made more permeable, says Johnathan Casey, an assistant professor of pulmonary critical care at Vanderbilt University Medical Center. Read More
For years, healthcare providers have treated children as miniature adults by prescribing them drugs approved for adult use (albeit at lower doses). But the FDA and other federal agencies are pushing for proof that these drugs are appropriate for younger patients and urging more pediatric-only trials or trials that enroll both adult and pediatric participants. Read More
Despite FDA rules meant to incentivize pediatric research, clinical studies for children and adolescents continue to lag significantly behind their adult trial counterparts. Read More
Sites that think they are too small, too busy or too inexperienced to monitor their billing and collections may be losing money they could easily recoup with some basic accounting procedures. Read More
Sites feeling overwhelmed by increasing administrative responsibilities lay more blame on sponsors’ shoulders than on additional compliance rules set by regulators. Read More
As the clinical trials industry slowly starts to transition to the COVID-19 “new normal,” sites and sponsors need to ask some tough questions, including who will bear the cost of restart, what staffing changes may be needed and what new technologies and skills will be required. Read More