All Times EDT
Keywords: Real World Evidence, Early Phase Oncology Trial
Recent cancer treatment has shifted from broad chemotherapy to highly personalized therapies. Therefore, it is important to detect the targeted population with high probability. Additional information from real world data at the early phase of development to assess the anti-tumor treatment effect or anti-tumor treatment heterogeneity facilitate better trial design and increase the probability of success for a new agent. Use of real-world evidence widen the scope of producing more robust analysis of the Oncology trial data at the early stage of development when trial data is sparse. Oncology drug development becomes highly competitive now due to the recent development of novel drugs and therapies. As a consequence, the investment team has been seeking the opportunity to include, to assess, and to incorporate the additional evidence to identify the appropriate patient population most in need of the new anti-cancer treatments in order to allocate the funding in proper direction. Nevertheless, some of the following questions but not limited to will be discussed in this session – (1) Will possessing information from the real-world databanks help in assessing the performance of the new compounds? (2) Will it support in taking interim decisions early in the expansion cohorts, for instance, in computing the early go-no-go criteria for Oncology endpoints, and thereby accelerating the process of Cancer drug development? (3) Can the real-world evidence be utilized in measuring the safety of a new compound, which is the main goal of early phase Cancer studies, (4) What are the major sources of real-world data to be adopted in helping the decision making in early clinical studies?