Clinical trial patient inclusion and exclusion criteria are far too rigid, often based on outdated notions, and the whole subject needs to be reimagined to include a more representative sample of the population. Read More
The European Union (EU) General Data Protection Regulation (GDPR) is set to become enforceable in just over a month, which is causing new work for those in clinical research, and carrying with it a brutal fine for noncompliance. Read More
The clinical research enterprise is “at best the sickliest link” in the chain between patients, the healthcare system, and science that can and should bring cures and better therapies, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). Read More
It used to be relatively straightforward to aggregate all safety data from a compound’s trials and send it to the FDA annually, as required. As the sponsor, you either had the data within easy reach in your files, or the one or two CROs you’d outsourced to could easily pull it together. It was simple. Read More
While the burgeoning amount of data collected in clinical trials promises to add more depth and breadth to study endpoints, leading to better studies and better drug therapies, for now it’s doing more harm than good by increasing data management burdens. Read More