Recent Evidence of Shifting Cancer Drug Development Pathways

Randomized clinical trials are most often used to demonstrate efficacy of novel anti-cancer drugs. Recently, several oncology drugs have shown efficacy in early phase studies and received regulatory approval based on data from non-randomized studies. Our recent research published in the Journal of Clinical Trials sought to determine if changes in numbers of non-randomized (NRCT) vs. randomized (RCT) oncology trials in recent years suggested a shift in oncology drug development pathways related to a better understanding of cancer biology and a more flexible regulatory drug approval process.