Adaptive designs are commonly applied to facilitate decision-making during a clinical trial and to lend early insight into anti-cancer activity. We routinely conduct combined dose escalation/dose expansion designs to quickly move from Phase I into Phase II for proof-of-concept. We refine patient selection by applying adaptive designs to evaluate a novel agent across multiple tumor types and combine biomarker and clinical data to drive decisions on the optimal tumor target(s) for further pursuit. By engaging sites from our Precision Oncology Site Network, as well as other reputable cancer centers with strong multi-disciplinary patient contributions, we are able to efficiently and predictably complete the targeted enrollment and effectively advance the progress toward approval.
With present and future novel compounds and immune therapies, it is critical to precisely understand not only what is happening with the patient’s clinical outcomes, but to also have insight into the activity at the level of the cancer cell. This combined data provides assurance that optimal information is available not only to the research team, but also to the patient’s physician, so that the appropriate therapies may be applied to prolong and improve the quality of life.
Precision Oncology’s integrated platform of bioanalytical services with clinical trial execution provides a unique offering for a truly “personalized” approach.