Insight and benefits from vaccine clinical trials with adaptive designs: a scoping review.

ABSTRACT: Vaccines are vital to global public health, especially as population growth and climate change increase the risk of infectious disease outbreaks. While randomized controlled trials (RCTs) remain the gold standard for evaluating vaccine safety and efficacy, traditional RCTs often face limitations including time constraints, resource demands, and ethical concerns. Adaptive endpoint-driven trial designs offer a promising alternative by allowing protocol modifications based on interim analyses while preserving scientific validity. Despite their potential, the adoption of such designs in prophylactic vaccine trials remains limited, with few real-world examples. This scoping review investigates the implementation of adaptive endpoint-driven methodologies in prophylactic vaccine RCTs. Using PRISM

SUBMITTER: Garcia-Sierra AM 

PROVIDER: S-EPMC12518217 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature