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health records (EHR) and medical claims data in drug and biologic clinical trials, publishing an extensive 35-page draft guidance for sponsors and researchers.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
Despite a range of efforts and heightened public awareness around the lack of diversity, clinical trials are still not representative of the U.S. population. Read More
To make FDA trial inspections go as smoothly as possible, it’s important for responsibilities to be divvied up strategically at sites and for certain documentation to be prepared before, during and after the FDA’s visit. Read More
With the modernization of ClinicalTrials.gov well underway, trial data submitters and users will see a number of new features in a test drive this fall before the updated CT.gov platform goes live in 2022. Read More
Quality culture is not just an industry buzzword; it’s incredibly important to the FDA, and the agency is intent on embedding it in clinical trials through proactive compliance rather than after-the-fact inspections. Read More
As the use of imaging in clinical research continues to grow, certain trials are requiring that sites meet increasingly complex and specific requirements for imaging technology and techniques. Those that can’t fulfill them may be passed over. Read More
Improving trial diversity is one of the most important issues in clinical research today, but defining diversity is more than just pointing to the usual underserved racial and ethnic minority groups. What’s required is a deeper dive into the factors that may keep people from participating in clinical trials. Read More
European pharma/biotech and medical device companies have not moved as rapidly to adopt decentralized and virtual trial approaches as their U.S. counterparts, but they recognize the potential of such methods and plan widespread use of them over the next three years, a new survey shows. Read More
The clinical trials industry must prepare for a paradigm shift in good clinical practice (GCP) principles when two impending revisions of key International Council on Harmonization (ICH) guidelines are finalized in the coming months. Read More