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Temporal evolution of publication bias in drug safety assessment: A case study on association between osteonecrosis of the jaw and bisphosphonates

Year: 2025

Type: article

Abstract: OBJECTIVES: The association between bisphosphonates (BP) and osteonecrosis of the jaw (ONJ) has been studied since 2006. However, meta-analyses conducted in 2014 and 2024 detected publication bias. Although it is often assumed that such bias diminishes over time, possibly due to the delayed publication of non-significant results, this trend has not been empirically confirmed in medicine. The aim of this study was to assess how publication bias has evolved in this safety context over time. METHODS: ). RESULTS: Forty-four studies published between 2006 and 2025 were included. Publication bias was detected from 2008 to 2025. The ROR increased from 0.42 in 2008 to 0.66 in 2025, indicating overestimation of 58% and 34%, respectively. The greatest impact was observed between 2013 and 2020. Subgroup analyses showed stronger residual bias in non-cancer indications. CONCLUSIONS: Although publication bias decreased over time, its impact persisted for 17years. Consequently, risk perception may remain distorted for an extended period. This observation mirrors the dynamics of pharmacovigilance alerts, which often rely on initial publications. When publication bias is identified in previous meta-analyses, future updates should carefully reassess its presence, even many years later.

Source: Joint Bone Spine

DOI: 10.1016/j.jbspin.2025.105970