Clinical Leader

1 week ago | clinicalleader.com | Miranda McLaren

By Miranda McLarenExplore the transformative potential of community-based research sites in clinical trials, particularly in enhancing patient experiences and fostering diversity. Traditional trial models often struggle to recruit minority populations due to logistical barriers, but community-based approaches significantly improve accessibility and engagement.

1 week ago | clinicalleader.com | Miranda McLaren

By Miranda McLarenThe obesity drug development landscape is rapidly evolving, driven by the World Health Organization's recognition of obesity as a critical public health problem. With projections indicating over 161.5 million cases in major pharmaceutical markets by 2033, the demand for effective treatments is surging.

1 week ago | clinicalleader.com | Moe Alsumidaie

By Clinical Trial Vanguard and Moe AlsumidaieThe FDA's September 2024 guidance on decentralized clinical trials (DCTs) marks a pivotal shift in clinical research, recognizing the growing integration of decentralized elements like in-home visits, mobile research sites, and telehealth within a regulated framework. This approach is designed to expand accessibility, improve diversity, and enhance participant retention without sacrificing data integrity or safety.

1 week ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderOver the past few weeks, I've been speaking with former FDA investigators to get their take on what clinical sites are doing right, what they're doing wrong, and what they absolutely must be ready for. One of my favorite conversations was with Tracey Harris, who spent eight years with the FDA conducting inspections across sponsors, IRBs, and clinical sites as part of the Bioresearch Monitoring (BIMO) program.

2 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderIt's not every day that a mock regulatory inspection reveals a closet full of mold-covered records fused together by water damage and crawling with spiders - but that's exactly what Sarah Moeller encountered during one of her more memorable site visits. Her reaction was decisive: iron out the pages to salvage what could be saved, locate digital backups, and prepare to disclose the issue transparently to regulators.