Standard operating procedures (SOP) are not just necessary for keeping a trial on track, they are mandatory for the FDA and the first documents requested during an inspection. They must be clear, comprehensive and — most important — followed to the letter if a site is to survive close scrutiny.
Community engagement is a must-have component of virtually any diversity, equity and inclusion (DE&I) program, and one academic research center has pioneered a program that brings its community’s culture into its clinical trials.
An international group dedicated to fostering more complete, higher-quality trial protocols has released new guidelines that recommend nine characteristics of effective trial outcome reporting that can be applied to protocols regardless of a trial’s design or population. Read More
Identifying and communicating the stories clinical trial data tell is critical to delivering actionable insights, but it’s best to start small when organizing data into easily visualized images. Read More
A look back at the clinical trials landscape in 2022 shows that although record high levels of resignations, increasing scarcity of investigators and declining enrollment rates are slated to continue into 2023, the rate of trial starts appears to be stabilizing somewhat, giving sites a chance to possibly catch their breath in the new year. Read More
It’s been widely agreed that technology is the greatest hurdle sites face in implementing decentralized trial (DCT) components, but a recent think tank discussion has unveiled a new revelation: sites are now naming unclear regulatory requirements as the top barrier they face as DCTs continue to take form. Read More
Data monitoring committees (DMC) have seen growing use in clinical research and can play a critical role in monitoring for unanticipated problems as trials progress. For this reason, it’s important to know the situations DMCs are best suited for, how they should function and what to consider when deciding to assemble one. Read More
FDA inspections can glide smoothly or run off the rails, depending on how thoroughly and thoughtfully sites and sponsors prepare for them. Before the agency shows up, consider 10 key factors to gauge your inspection readiness. Read More
The language in clinical trial agreements (CTA) must be very specific to avoid legal problems during the trial, but certain terms have the potential, if not handled correctly, to derail the negotiation process before the trial gets off the ground. Read More
FDA inspections have been heavily focused on sponsor, CRO and site outsourcing activities since the Bioresearch Monitoring (BIMO) Program revised its manual for inspection processes in September 2021. Read More