Assurance in vaccine efficacy clinical trial design based on immunological responses
| Autor: | Andrea Callegaro, Toufik Zahaf, Fabian Tibaldi |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Statistics and Probability
Clinical Trials as Topic Vaccines medicine.medical_specialty business.industry Surrogate endpoint Clinical study design Bayes Theorem Context (language use) General Medicine Vaccine efficacy Confirmatory trial Clinical trial Drug development Sample Size medicine Clinical endpoint Statistics Probability and Uncertainty Intensive care medicine business |
| Zdroj: | Biometrical Journal. 63:1434-1443 |
| ISSN: | 1521-4036 0323-3847 |
| DOI: | 10.1002/bimj.202100015 |
| Popis: | The assurance of a future clinical trial is a key quantitative tool for decision-making in drug development. It is derived from prior knowledge (Bayesian approach) about the clinical endpoint of interest, typically from previous clinical trials. In this paper, we examine assurance in the specific context of vaccine development, where early development (Phase 2) is often based on immunological endpoints (e.g., antibody levels), while the confirmatory trial (Phase 3) is based on the clinical endpoint (very large sample sizes and long follow-up). Our proposal is to use the Phase 2 vaccine efficacy predicted by the immunological endpoint (using a model estimated from epidemiological studies) as prior information for the calculation of the assurance. |
| Databáze: | OpenAIRE |
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