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."
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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
