discussion period. Unlike EMA, said a participant, FDA is prohibited from releasing patient-level data by statute and regulation, presenting a major legal barrier to data sharing. Robert Califf, Duke University Medical Center, contended that the reports companies send to FDA should be made public, along with the internal FDA analysis. Today, if a drug does not get to the market, federal law prohibits the release of these documents, but companies still could make these reports public, he said, even if FDA currently cannot.
Steven Goodman, who, in addition to his academic appointment at Stanford University School of Medicine is also associate editor at Annals of Internal Medicine and editor at Clinical Trials, discussed the role of journals in promoting data sharing and the challenges they face. In a paper published in Annals of Internal Medicine in 2007, Goodman and several colleagues announced a new policy the journal was adopting to require that manuscripts include a reproducible research statement (Laine et al., 2007a). Such a statement would say whether the study protocol, code, and dataset are available and how to get each. Goodman labeled this a “weak” solution, but he also said that if Annals of Internal Medicine makes demands that are difficult to fulfill, authors will simply publish their articles elsewhere. “Journals are competitive with each other. They also want to publish the best stuff. And they can’t put up barriers that nobody else is putting up,” Goodman said. The requirement has at least shined a light on the problem, but some authors have simply said that data are not available or have referred readers to the large databanks from which the data in the study were derived. Polling by journal staff has indicated that the number of requests authors are receiving for data, statistical code, and protocols is still fairly low.
Journals cannot be effective acting alone, said Goodman. To really shift the culture surrounding data sharing, journals will need to agree on a common set of principles and sanctions, such as requiring that the authors of articles share data on request. Although a few other journals have adopted the reproducible research statement policy, in general, journals are taking their own approaches to dealing with data sharing and the issue of reproducibility, and some have no such policies at all. One success story mentioned by Goodman was clinical trial registration. Though the system still needs to be improved, he said, it has worked well