ARRA

"FDA houses the largest known repository of clinical data — unique, high-quality data on the safety, effectiveness and performance of drugs, biologics and devices, both before and after approval," the agency said in its priorities report. "Despite the availability of these data, questions about subpopulation responses and underlying placebo effects remain unanswered."

The company aims to show that its web-based, customer-reported data-gathering model yields results comparable to traditional research methods — both in terms of the accuracy of phenotypic data reported by customers, as well as the overall ability of the approach to replicate known associations between genes and drug response.

According to Woodcock, comparative effectiveness research and personalized medicine can come together in conducting community-based research. But for that, the US research infrastructure needs to be improved.