FDA released a strategic plan to advance regulatory science on Aug. 17, 2011, in an effort to “keep pace with and utilize…new scientific advances” and to promote public health. The plan is based on the agency’s 5-year strategic goals (see back story) and its October 2010 report on advancing regulatory science (see back story). The plan outlines eight priority areas that describe how FDA intends to gather and communicate information and advance tools and product quality. Priority 5 caught my eye. It aims to harness diverse data using information sciences. The idea is to integrate and analyze data from various sources, and one such program will involve opening product applications.

States the report, “By integrating and analyzing these data, FDA will be able to provide industry with new information that can be applied to future product development and potentially save billions of dollars in development costs.” Essentially, various sources (e.g., product applications, adverse-event reports, healthcare provider information, surveys, clinical studies, comparative-effectiveness studies) can provide knowledge and insight that cannot be gained from one source alone, notes the report.

One data-unlocking program tied to product applications reviewed by FDA is called PACES, which stands for the Partnership in Applied Comparative Effectiveness Science project. The project is funded by FDA and includes academic collaboration. The partnership facilities pilot projects to “conduct advanced analyses to detect clinical trends” that can determine which interventions will be most effective for patients under certain conditions. “This will cut out many of the headaches of trial-and-error to find the right treatment for a particular patient,” states the report. Sound like personalized medicine? In fact, Priority 2 of the FDA strategic report focuses entirely on personalized medicine and patient outcomes as tied to clinical evaluations.

Other parts of the information-science enhancement goal will include improving FDA’s IT infrastructure, applying simulation models, analyzing large scale clinical and preclinical data sets, incorporating knowledge from regulatory files into a database that integrates various data types, and developing new data sources and analytical methods/approaches.

Overall, the effort to integrate data is a good one. FDA has endless amounts of information at its fingertips and that data is spread across various files, groups, divisions, and centers within the agency. The FDA report gives the example of toxicology data. The agency would like to incorporate that information into a single database to facilitate the use of predictive toxicology models and model validation.

It’s not yet known how industry may feel about this mining of data, but ideally, the move will take science in the right direction and open the door to new therapies, which is the ultimate goal of regulators and industry alike.