FDA Commissioner Wants To Build Preclinical Database

Robert Califf, the commissioner of the US Food and Drug Administration (FDA) thinks an official database for preclinical studies should be established in order to help improve transparency in basic research. The database would be modeled after ClinicalTrials.gov, an online clinical trials registry in which sponsors are required to register their studies.

According to Califf, the goal of the preclinical database would be to gather data from studies conducted in cell culture or on animal models. Califf hopes that providing preclinical data in a public-accessible database could help improve future researchers’ attempts to reproduce study results.

“One of the problems that we have at the FDA in this regard is that trade secrets at the FDA are protected by the law,” said Califf. “And 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.

“Because there is no compelling reason to publish them, if they’re successful, they become trade secrets,” Califf continued. “And if they’re unsuccessful, they get dropped and no one cares if they’re published. If you think reproducibility and the fabric of science, in some ways, if it were possible, it would really be good to have something like a ClinicalTrials.gov for preclinical work.”

ClinicalTrial.gov collects clinical trials data from hospitals, research universities and pharmaceutical companies conducting treatment studies on humans. Though these study sponsors are required to report this data by law, up to 70 percent of trials go unreported on the government website.

Currently, no preclinical database exists to aggregate study results from in vitro trials. As a result of this lack of data sharing, preclinical research used to advance a drug into human clinical trials, often cannot be replicated later on. Publication basis towards studies with negative or inconclusive results serves to further complicate the issue.

“Knowing what the dead ends are would make things more efficient for the system as a whole,” said Stuart Buck, leader of the Research Integrity initiative at the Laura and John Arnold Foundation. By registering preclinical data, prospective researchers would know what studies have already been performed and what the results of that work were. This would eliminate some redundancy among researchers, allowing them to make better study decisions from the onset.

Not everyone agrees that a preclinical database would solve these difficult issues. According to Elizabeth Iorns, founder and CEO of the Science Exchange – a company that fosters collaboration in the research community – says that funding for replicative research is simply not available.

“There’s no funding for it. Nobody wants to do it. No one publishes it,” Iorns told STAT. “Exploratory research is exploratory. You shouldn’t preregister it. You shouldn’t have a statistical analysis planned. That would be crazy. It would stifle so much innovation and serendipity that just happens.”