Andrew von Eschenbach was commissioner of the Food & Drug Administration from 2006-2009, following the resignation of Les Crawford, his predecessor. Prior to leading FDA, he was the director of the National Cancer Institute and obviously has an affinity for the new breed of targeted, personalized oncology treatments that have emerged in the past few years.
In an article written for Bloomberg, Eschenbach states that changing the agency’s burdensome requirements for clinical trials could help double the number of new drug approvals. According to his statements, Phase III studies are unnecessarily large and cumbersome for more precise and personalized medicine. Instead, he suggests adopting smaller, targeted study parameters and greater post-approval monitoring for such drugs: “Phase III trials often fail to recognize the unique benefits that medicines can offer to smaller groups of patients than those required in trials.” From data presented, the benefit would lie in faster approval times, more approved products and a stronger economy.
