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
Cell and gene therapy (C>) research is seeing unprecedented growth in the need for sites, but there are many critical considerations specific to C> that sites need to make before they can take on these trials. Read More
Patients have spoken: Flexibility, including the option of in-person visits, is still vital to their willingness to take part in trials even after the pandemic made remote and virtual approaches the norm, a global survey has found. Read More
Sites around the world were largely pleased with the support sponsors gave during the pandemic, naming direct-to-patient shipments, remote monitoring and remote site visits as the most important innovations employed during the crisis. Read More
Site tiering as a risk-based quality management (RBQM) tool is still being refined, but is gaining traction with some sponsors, especially for research-naïve sites. Read More
After months of speculation that the public draft version of ICH E6(R3) would land in January 2022, an FDA official confirmed that ICH is on target to meet that timeline despite months of COVID-19 delays. M. Khair ElZarrad, FDA’s acting director of the Office of Medical Policy and the agency’s rapporteur for the revision, said last week that the long-awaited guideline will be out in early 2022. Read More
The FDA has issued its most detailed guidance yet on using electronic health records (EHR) and medical claims data in drug and biologic clinical trials, publishing an extensive 35-page draft guidance for sponsors and researchers. Read More
Key members of the healthcare workforce endured concerning levels of stress during the height of the pandemic, with more than half of nurses and roughly one in three physicians experiencing high amounts of strain, a survey has found. Read More