March-April 2019 (Volume 20, Number 2) : PDF
Big Data trends in clinical research
When the first painting completed by an artificial intelligence (AI) algorithm sold last year for 45 times higher than expected ($432,500 vs. $10,000), it was a key lesson in the allure and potential of Big Data. As Albert Einstein noted: “The greatest scientists are artists as well.”
FDA IRB inspections: What, why and how
Institutional review boards (IRB) oversee the design and conduct of clinical trials, but they themselves are subject to strict oversight by the FDA, which regularly conducts inspections to assess IRBs’ compliance with a slate of federal regulations.
Routine and not-so-routine IRB inspections
Institutional review boards (IRBs) should expect a routine FDA inspection about every five years. But don’t count on that timeline, advises one IRB executive. IRBs should always be “inspection ready,” says David Borasky, vice president of quality management, quality assurance and compliance for the WIRB-Copernicus Group (WCG) in Princeton, N.J. “I don’t find the FDA to be that predictable.”