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Preclinical Project Database Proposed

US Food and Drug Administration Commissioner Robert Califf has suggested that a database of preclinical trials might help the field overcome its reproducibility issues, Stat News reports.

In 2013, Amgen researchers announced that they were unable to reproduce the findings of 47 out of 53 landmark cancer papers, and similar reproducibility issues have plagued psychological research. At an event hosted by the National Library of Medicine, Califf said that a ClincalTrials.gov-like database could help address the problems researchers have run into when attempting to reproduce major research results.

"I've always felt that one of the most important things that could be done, if it could be, would be free up all the data from the drug development process that is never seen by anyone," Califf said. "If they're successful, they become trade secrets. And if they're unsuccessful, they get dropped and no one cares if they're published." But they could, he argued, become part of a database of preclinical work.

While Elizabeth Iorns from Science Exchange says the idea is interesting, she notes there is rarely any funding for replicating research. In addition, she says that preclinical work is generally exploratory and that would make it difficult for researchers to pre-register their studies.

Califf, Stat News adds, seems to recognize that issue. He added that he'd proposed such an idea when he was at Duke and "[p]eople's hair caught on fire and they ran out of the room at the very idea."