Nowadays, drug development in oncology is largely centered on the basic premise of precision medicine, according to which targeted agents are used based on the expression of predictive biomarkers. Even though late-phase trials of precision oncology are undergoing transformations, we believe that the greatest impact of precision oncology has been in the design of early-phase trials. By this we mean not only basket, umbrella, and platform designs used in phase 2, but also phase 1 trials, especially those with expansion cohorts. One evident current trend is an earlier focus on treatment efficacy than in the past. Also, increasing competition and demands for return on investment often put smaller companies under extreme pressure to generate evidence for the efficacy of their products early on in clinical development. Our goal when assisting these companies is to balance speed and reliability in the design and implementation of early-phase trials.
Contributed Commentary by Elisabeth Coart, PhD, PRINCIPAL STATISTICIAN IDDI and Everardo Saad, MD MEDICAL DIRECTOR IDDI
