Cardiovascular Trials Down, Study Finds; Califf Outlines FDA Stance

The number of cardiovascular drugs entering the clinical development pipeline has been declining since 1990, according to a study evaluating public data from over 4,000 trials. The decline was seen across Phase I, II, and III clinical trials.

The study authors cited the high cost of Phase III trials, stagnant financial investment, and the competition of generic drugs among the causes of the decline. While the largest drugmakers continue to sponsor the most clinical trials, the share of trials run by smaller companies has increased.

“These trends are concerning and raise the question of whether regulators, other government entities, industry, and academic investigators should rethink the approach to the science we need to reduce disease burden in this enormous cause of global death and disability,” wrote FDA Commissioner Robert Califf; Norman Stockbridge, director of the FDA’s Division of Cardiovascular and Renal Products; and Mona Fiuzat, an adjunct associate professor at the Duke University School of Medicine, in an accompanying editorial.

Califf and the other editorial authors acknowledged calls for “reducing regulatory uncertainty” in pursuit of accelerating research, but said that could not mean using smaller sample sizes or surrogate endpoints in late-stage clinical trials.