A cargo van designed to serve as a fully functional mobile clinical trial site took the checkered flag as winner of this year’s WCG Innovation Challenge, presented last week at the 2024 MAGI Clinical Research Conference in New Orleans. Read More
Although AI holds great potential in optimizing and advancing clinical research, the risks and ethical concerns it presents must be considered when using it in clinical trials, the World Health Organization (WHO) cautions in a recent report. Read More
To avoid being caught out by sponsors that don’t follow clinical trial regulatory requirements, sites should make sure before they accept a trial that its monitoring, site activation and site coordination efforts are compliant, a lesson driven home by a recent FDA Warning Letter. Read More
The recruitment and retention of Bioresearch Monitoring (BIMO) program investigators has been a thorn in the side of the FDA that’s negatively impacted trial inspections, a Government Accountability Office (GAO) audit has found. Read More
Inspired by lackluster efforts to improve diversity, equity and inclusion (DE&I) in clinical research, two centers at the University of Pennsylvania (UPenn) have moved to publish the core methodologies and practices they developed to boost DE&I within their trials. Read More
Patient response to new digital components in the electronic informed consent (eIC) process is overwhelmingly positive, with nearly three-fourths of respondents to a recent survey saying they find enhanced eIC more personable, engaging and informative. Read More
This monthly feature presents questions from clinical trial professionals with answers from experts. In this issue, we feature insights from Christopher Doyle, WCG IBC chair and director of IBC services, and Amy Michaud, WCG biosafety analyst lead. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
The FDA has been busy this month issuing guidances on data monitoring committees (DMC), charging for investigational drugs and assessing COVID-19-related symptoms in outpatient trials. The agency also extended the comment deadline on its guidance for master protocols to March 21. Read More
The utilization of websites for trial recruitment has nearly tripled since 2019, while social media platforms and patient advocacy groups have doubled in use, according to a study that offers new insights into the top recruitment methods used for trials postpandemic, among other data. Read More