Keywords: vaccine, hybrid design
With the advancement of technologies and availability of RWD, there is increasing interest from the pharmaceutical industry and regulators alike to utilize such data. Hybrid design preserves the benefit of randomization, provides real-world outcome data and potentially accelerates product development and lowers the costs of data collection and patient follow-up. In this presentation, we focus on design considerations for hybrid trials to support regulatory decisions from a sponsor’s perspective. We emphasize vaccine development where such hybrid designs are particularly useful given the low incidence rates of some vaccine preventable clinical outcomes. We propose program strategies on how such hybrid designs may be integrated into a clinical development plan. Major challenges are discussed and recommendations are provided.