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
Social media platforms are giving traditional television, print and radio advertising a run for their money, according to one marketing expert who says lower cost is not the only benefit of publicizing clinical trials on Facebook, Instagram, Twitter and Pinterest. Read More
Bayer’s efforts to make the charitable donation of unused trial kits and supplies an industrywide practice earned it the top spot at the inaugural WCG Innovation Challenge held at the MAGI Clinical Research Conference West in Las Vegas, Nev., last week. Read More
Sites, sponsors, CROs and investigators that start preparing for an FDA inspection when they receive a notice from the agency may already be too late to ensure success. Instead, experts advocate for maintaining a constant state of “inspection readiness” to avoid last-minute problems and surprises. Read More
Although people with disabilities make up the largest minority group in the U.S., they have been largely left out of discussions of diversity, equity and inclusion (DE&I) in clinical trials, making them one of the most underrepresented populations in research, say two researchers who recommend sites and sponsors pay more attention to their unique needs. Read More
Bringing the trial to the patient has become a critical focus in research, but it’s important that efforts stay grounded on what patients truly want. A new survey shows a reluctance toward home visits — a mainstay of decentralized trial approaches — particularly among underrepresented groups. Read More
In the push to accelerate research by shortening clinical trials’ duration, sponsors and sites need to be aware of the risks “fast science” can introduce and focus on trial designs that are proven to maintain scientific integrity while speeding results. Read More