In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier to trial participation, digging deep into demographics and distribution of trials across US counties, as well as offering an interactive map tool filterable by therapeutic area. Read More

The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More

The European Medicines Agency (EMA) is continuing efforts to improve trials in the trade bloc, announcing two new programs that will offer support on clinical trial applications as new transparency rules under its Clinical Trials Information System (CTIS) come into effect. Read More

This monthly feature presents questions from clinical trial professionals with answers from experts. In this issue, we feature insights from Lindsay Abraham, WCG regulatory chair director and Bridget Brave, WCG director of expedited review IRB operations, on types of research that are exempt from the provisions of the Common Rule found in 45 CFR Part 46. Read More

Recent years have shown AI’s potential for advancing drug development is undeniable, with hundreds of drug submissions to the FDA referencing AI solutions. But AI’s integration in trials must be balanced with careful considerations for a number of unique challenges, says M. Khair ElZarrad, director of the Center for Drug Evaluation and Research’s Office of Medical Policy. Read More

Sponsors have rapidly shifted from employing traditional endpoints to utilizing digital endpoints — outcomes measured through digital technology — to collect clinical trial data, according to the latest Impact Report from the Tufts Center for the Study of Drug Development (CSDD). Read More

Adapting to the quality and risk management components embedded in the new ICH E6(R3) guidelines may present challenges for sponsors and providers, but it’s sites that may find the task particularly daunting, findings from an Avoca survey show. Read More

Precautions for securing a trial’s investigational drug(s) must be ironclad in the eyes of the FDA, and corrective and preventive actions enacted when these safeguards are absent or compromised must be just as rigorous, a recent FDA warning letter illustrates. Read More

This monthly feature presents questions from clinical trial professionals with answers from experts. In this issue, we feature insights from WCG IRB Chair Erin Brower on the differences between eConsent and eSignatures. Read More

The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with clinical trials. Read More