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
With clinical research professionals exiting the industry in droves, it’s high time for research institutions to step back and assess themselves internally, evaluating how their own paradigms, cultures and priorities affect employees. Read More
The FDA has signaled its support for the use of real-world data (RWD) — information gleaned from health records, patient registries and other sources — through pilot programs and guidances but has yet to set standards for the quality of that data, leaving sponsors, investigators and sites to find their own way to evaluate its relevance and reliability. Read More
At the intersection of risk-based quality management (RBQM) and performance metrics, sponsors are increasingly using centralized monitoring approaches to analyze data from sites that can predict risk and identify sites that may need additional support. Read More
Resumes and traditional interviews don’t always provide a complete and accurate picture of job candidates, as St. Lawrence Health System learned the hard way. Seeking a better view of potential hires, they’ve created a process that appraises soft skills and traits that can’t be adequately assessed through resumes and generic interview questions. Read More
Close sponsor contact, rapidly moving targets and timelines, unique facility and staff needs — these are only some of the factors that can make phase 1 trials more challenging for sites than the other phases, say several oncology research experts who offer advice for sites considering signing up for early-stage research. Read More