FDA Attorney Edward Allera Quoted on Challenges of Retrospective Analyses of Data

Edward John Allera, chairman of the Buchanan Ingersoll & Rooney's FDA/Biotechnology Section and a managing shareholder of the firm's Washington, D.C., office, was quoted in an article published in the June 2009, edition of Good Clinical Practice Journal. The article, titled " A glimmer of hope for retrospective analyses of data," discussed how the FDA is beginning to seriously consider the submission of after-the-fact analyses of clinical trials.

According to the article, "The U.S. Food & Drug Administration (FDA) has long viewed retrospective analyses of data with suspicion, demanding that any clinical trial data submitted be the data the trial set out to gather in the first place. Retrospective analyses were routinely rejected out of hand. … But that attitude is on the verge of changing."

The article went on to say, "Such analysis will be increasingly relevant as medicine makes strides towards personalizing treatments and more and more genomic biomarkers are recognized. A greater receptivity to retrospective analyses will present new data management challenges to those designing and running trials. And IT firms are fielding new products specifically designed to help meet those challenges."

Allera weighed in, saying that "there are now unanswered questions about how to handle the data, especially cell samples, such as how to maintain them and for how long. And the challenges are all the greater because it is almost impossible today to gauge what attributes of trial participants may be significant some years down the road."