Featured presentation: HL7, CDISC and the FDA - Moving on Down the Path to Data Standards

Stephen E. Wilson, Director of Biometrics III, Food and Drug Administration (FDA), was a presenter for the SAS Industry Solutions’ Pharma, Life Sciences and Healthcare section on Tuesday. Wilson, who’s used SAS since he was an undergrad at the University of North Carolina in the mid-1970s, addressed the globalization of clinical research.

“There are big experiments taking place, multicenter trials, 872 in India alone, and by big companies,” said Wilson.

“There are more regions, more trials than ever before. Companies are outsourcing data management, and the government is passing legislation that has implications for what data we collect and how we collect and store it,” said Wilson.

The FDA strives to be a good steward of data, said Wilson, by bringing in data from a number of companies and making it available so that companies can collaborate for the betterment of science.

The volume of submissions is staggering, but as the FDA is working toward a vision of global standards (such as eCTD – electronic common technical documents for uniform submissions), it’s also working hard to keep up with current volume.

According to Wilson, the FDA is looking for programmers and data architects to help with these efforts. “We want you for the FDA,” joked Wilson. He closed by telling the crowd, “We are all still riding the same elephant, and we should all be collaborating and working together.”

Featured presentation: HL7, CDISC and the FDA - Moving on Down the Path to Data Standards was published on SAS Users.