Considering the Critical Path in Oncology Drug Development

In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."

Bertil Jonsson, MD, PhD, Medical Products Agency, Sweden, said that biomarkers and confirmatory studies can be an alternative measure, but added that "more data is needed." Jonsson also said that conditional approvals are viable, so long as they demonstrate "dramatic, obvious effects."

Speaking from the U.S. regulatory perspective, Robert L. Justice, MD, medical officer, CDER, said major opportunities to speed drug development include modernizing clinical trials, including adaptive trial designs and improving the problem of missing data.

"At the end of the development process, we don't know a whole lot about the drug," he lamented. Modernization solutions cited by Grant A. Williams, MD, clinical development, GlaxoSmithKline, include enrichment designs that target subgroups and focus on patient safety. One such design divides subjects into pharmacogenomic positive and negative groups, which are both subsequently randomized.