Abstract：
UNASSIGNED: From 2009 to 2015, the IMI PROTECT conducted rigorous studies addressing questions about optimal implementation and significance of disproportionality analyses, leading to the development of Good Signal Detection Practices. The ensuing period witnessed the independent exploration of research paths proposed by IMI PROTECT, accumulating valuable experience and insights that have yet to be seamlessly integrated.
UNASSIGNED: This state-of-the-art review integrates IMI PROTECT recommendations with recent acquisitions and evolving challenges. It deals with defining the object of study, disproportionality methods, subgrouping, masking, drug-drug interaction, duplication, expectedness, the debated use of disproportionality results as risk measures, integration with other types of data.
UNASSIGNED: Despite the ongoing skepticism regarding the usefulness of disproportionality analyses and individual case safety reports, their ability to timely detect safety signals regarding rare and unpredictable adverse reactions remains unparalleled. Moreover, recent exploration into their potential for characterizing safety signals revealed valuable insights concerning potential risk factors and the patient\'s perspective. To fully realize their potential beyond hypothesis generation and achieve a comprehensive evidence synthesis with other kinds of data and studies, each with their unique limitations and contributions, we need to investigate methods for more transparently communicating disproportionality results and mapping and addressing pharmacovigilance biases.
UNASSIGNED: This state-of-the-art review integrates IMI PROTECT recommendations with recent acquisitions and evolving challenges. It deals with defining the object of study, disproportionality methods, subgrouping, masking, drug-drug interaction, duplication, expectedness, the debated use of disproportionality results as risk measures, integration with other types of data.
UNASSIGNED: Despite the ongoing skepticism regarding the usefulness of disproportionality analyses and individual case safety reports, their ability to timely detect safety signals regarding rare and unpredictable adverse reactions remains unparalleled. Moreover, recent exploration into their potential for characterizing safety signals revealed valuable insights concerning potential risk factors and the patient\'s perspective. To fully realize their potential beyond hypothesis generation and achieve a comprehensive evidence synthesis with other kinds of data and studies, each with their unique limitations and contributions, we need to investigate methods for more transparently communicating disproportionality results and mapping and addressing pharmacovigilance biases.
摘要：
■从2009年到2015年，IMIPROTECT进行了严格的研究，解决了有关最佳实施和不成比例分析的重要性的问题，导致良好信号检测实践的发展。随后的时期见证了IMIPROTECT提出的研究路径的独立探索，积累尚未无缝集成的宝贵经验和见解。
■这项最新的审查将IMIPROTECT建议与最近的收购和不断发展的挑战相结合。它涉及定义研究对象，不成比例的方法，分组，掩蔽,药物-药物相互作用，重复，期待,有争议的使用不相称性结果作为风险衡量标准，与其他类型的数据集成。
■尽管对不相称性分析和个别病例安全性报告的有用性持怀疑态度，他们及时发现罕见和不可预测的不良反应的安全信号的能力仍然是无与伦比的。此外，最近对其表征安全性信号的潜力的探索揭示了有关潜在风险因素和患者观点的宝贵见解。为了充分发挥其超越假设产生的潜力，并与其他类型的数据和研究进行全面的证据综合，每个人都有其独特的局限性和贡献，我们需要研究更透明地传达不相称性结果,并绘制和解决药物警戒偏差的方法.
■这项最新的审查将IMIPROTECT建议与最近的收购和不断发展的挑战相结合。它涉及定义研究对象，不成比例的方法，分组，掩蔽,药物-药物相互作用，重复，期待,有争议的使用不相称性结果作为风险衡量标准，与其他类型的数据集成。
■尽管对不相称性分析和个别病例安全性报告的有用性持怀疑态度，他们及时发现罕见和不可预测的不良反应的安全信号的能力仍然是无与伦比的。此外，最近对其表征安全性信号的潜力的探索揭示了有关潜在风险因素和患者观点的宝贵见解。为了充分发挥其超越假设产生的潜力，并与其他类型的数据和研究进行全面的证据综合，每个人都有其独特的局限性和贡献，我们需要研究更透明地传达不相称性结果,并绘制和解决药物警戒偏差的方法.
