Is this drug safe and effective?

I've been with the FDA since 1996 (except for a one year "sabbatical" -- that's a long story). Much of my work has focused on modernizing how FDA assesses the safety and effectiveness of new drugs.  Pharmaceutical manufacturers ("sponsors") conduct the clinical trials. They send FDA the data, and the Agency conducts an independent analysis of the results.

Analyzing clinical trial data is an extremely tedious and remains largely a manual process. I have recently spent a good deal of my time at FDA on projects that try to make the data more accessible, standardizing the data (to make the data more useful and to enable automated analytic processes), and developing, identifying, deploying tools (e.g., analytic software) to help physicians, statisticians, and other scientists understand and interpret the data. The goal is to make more efficient and effective safety and efficacy determinations to get the right new drugs to patients more quickly. I have written about these three components of an improved informatics infrastructure for clinical research.

I've now decided to leave the FDA. I feel my work there is done and it's time to pass the torch to the next generation of scientists-informaticist that will continue to advance the ongoing medical informatics revolution. I will continue to monitor and contribute to this revolution wherever I can, and will document my experiences here.