Related Experiment Video
Updated: Aug 15, 2025

Dynamic Monitoring of Seroconversion using a Multianalyte Immunobead Assay for Covid-19
Published on: February 16, 2022
Vaccine clinical trials with dynamic borrowing of historical controls: Two retrospective studies
Andrea Callegaro1, Naveen Karkada1, Emmanuel Aris1
1Department of Biostatistics, GSK, Rixensart, Belgium.
Abstract:
Traditional vaccine efficacy trials usually use fixed designs with fairly large sample sizes. Recruiting a large number of subjects requires longer time and higher costs. Furthermore, vaccine developers are more than ever facing the need to accelerate vaccine development to fulfill the public's medical needs. A possible approach to accelerate development is to use the method of dynamic borrowing of historical controls in clinical trials. In this paper, we evaluate the feasibility and the performance of this approach in vaccine development by retrospectively analyzing two real vaccine studies: a relatively small immunological trial (typical early phase study) and a large vaccine efficacy trial (typical Phase 3 study) assessing prophylactic human papillomavirus vaccine. Results are promising, particularly for early development immunological studies, where the adaptive design is feasible, and control of type I error is less relevant.
More Related Videos
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Crossover Experiments
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Study Designs in Epidemiology
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Blinding

