The average number of trial endpoints has increased by 6 percent on average each year since 2003, leading sites to struggle to meet sponsor deadlines and overwhelmed by the amount of work required to handle such complex trials. Read More
Risk management may be an integral part of conducting a trial, but in the past year sites have been overwhelmed with emergency measures needed to keep their trials running, leaving them little time to attend to the formal processes of identifying, assessing and mitigating risk. As the COVID-19 crisis eases in coming months, however, sites will need to refocus their attention and efforts on their risk management programs. Read More
FDA veteran Janet Woodcock has reportedly been short-listed by the incoming Biden administration to serve as the agency’s next commissioner and will also likely serve as acting chief until the position is filled. Read More
Patient advocacy groups in India are claiming that Bharat Biotech failed to ensure trial participants clearly understood their role in a study of the company’s Covaxin COVID-19 vaccine. Read More
Biogen plans to launch a multi-year, observational trial later this year to monitor data from Apple Watches and iPhones to identify digital biomarkers of mild cognitive impairment. Read More
The FDA’s plan for regulating clinical trials in 2021 will focus on increasing participant diversity, encouraging complex and innovative trial designs, and qualifying new drug development tools. Read More
Sponsors of generic drug products that need to conduct bioequivalence (BE) trials during the COVID-19 pandemic should develop site-specific plans to either quarantine or separate participants to minimize their exposure to the virus, according to a final guidance released by the FDA last week. Read More
