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
Drastic changes in drug development mean quality management approaches are more critical than ever, with meaningful advancement hinging on cultural shifts, crossfunctional alignment and top-down approaches within organizations, as well as thoughtful, stakeholder-informed trial designs. Read More
Boehringer Ingelheim (BI) has done a full 180-degree turn on patient involvement in trial design in recent years, moving from virtually no patient input to incorporating patient feedback in nearly all of its protocols today. The German pharma giant elaborated on how it accomplished this during a session at the 2024 Summit for Clinical Ops Executives (SCOPE). 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
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing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
Since 2021, patients have grown considerably more amenable to taking part in clinical trials, a new survey by the Center for Information & Study on Clinical Research Participation (CISCRP) has found. Read More