Meta-analysis of Censored Adverse Events
Fuente:
arXiv
Guardado en:
| Autores principales: | , , , , , , |
|---|---|
| Formato: | Preprint |
| Publicado: |
2021
|
| Materias: | |
| Acceso en línea: | |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| _version_ | 1866910323269697536 |
|---|---|
| author | Qi, Xinyue Zhou, Shouhao Peterson, Christine B. Wang, Yucai Fang, Xinying Wang, Michael L. Shen, Chan |
| author_facet | Qi, Xinyue Zhou, Shouhao Peterson, Christine B. Wang, Yucai Fang, Xinying Wang, Michael L. Shen, Chan |
| contents | Meta-analysis is a powerful tool for assessing drug safety by combining treatment-related toxicological findings across multiple studies, as clinical trials are typically underpowered for detecting adverse drug effects. However, incomplete reporting of adverse events (AEs) in published clinical studies is a frequent issue, especially if the observed number of AEs is below a pre-specified study-dependent threshold. Ignoring the censored AE information, often found in lower frequency, can significantly bias the estimated incidence rate of AEs. Despite its importance, this common meta-analysis problem has received little statistical or analytic attention in the literature. To address this challenge, we propose a Bayesian approach to accommodating the censored and possibly rare AEs for meta-analysis of safety data. Through simulation studies, we demonstrate that the proposed method can improves accuracy in point and interval estimation of incidence probabilities, particularly in the presence of censored data. Overall, the proposed method provides a practical solution that can facilitate better-informed decisions regarding drug safety. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2101_07934 |
| institution | arXiv |
| publishDate | 2021 |
| record_format | arxiv |
| spellingShingle | Meta-analysis of Censored Adverse Events Qi, Xinyue Zhou, Shouhao Peterson, Christine B. Wang, Yucai Fang, Xinying Wang, Michael L. Shen, Chan Methodology Applications Meta-analysis is a powerful tool for assessing drug safety by combining treatment-related toxicological findings across multiple studies, as clinical trials are typically underpowered for detecting adverse drug effects. However, incomplete reporting of adverse events (AEs) in published clinical studies is a frequent issue, especially if the observed number of AEs is below a pre-specified study-dependent threshold. Ignoring the censored AE information, often found in lower frequency, can significantly bias the estimated incidence rate of AEs. Despite its importance, this common meta-analysis problem has received little statistical or analytic attention in the literature. To address this challenge, we propose a Bayesian approach to accommodating the censored and possibly rare AEs for meta-analysis of safety data. Through simulation studies, we demonstrate that the proposed method can improves accuracy in point and interval estimation of incidence probabilities, particularly in the presence of censored data. Overall, the proposed method provides a practical solution that can facilitate better-informed decisions regarding drug safety. |
| title | Meta-analysis of Censored Adverse Events |
| topic | Methodology Applications |
| url | https://arxiv.org/abs/2101.07934 |