Model‐based meta‐analysis (MBMA) can be used in assisting drug development and optimizing treatment in clinical practice, potentially reducing costs and accelerating drug approval. We aimed to assess the application and quality of MBMA studies. We searched multiple databases to identify MBMA in pharmaceutical research. Eligible MBMA should incorporate pharmacological concepts to construct mathematical models and quantitatively examine and/or predict drug effects. Relevant information was summarized to provide an overview of the application of MBMA. We used AMSTAR‐2 and PRISMA 2020 checklists to evaluate the methodological and reporting quality of included MBMA, respectively. A total of 143 MBMA studies were identified. MBMA was increasingly used over time for one or more areas: drug discovery and translational research (n = 8, 5.6%), drug development decision making (n = 42, 29.4%), optimization of clinical trial design (n = 46, 32.2%), medication in special populations (n = 15, 10.5%), and rationality and safety of drug use (n = 71, 49.7%). The included MBMA covered 17 disease areas, with the top three being nervous system diseases (n = 19, 13.2%), endocrine/nutritional/metabolic diseases (n = 17, 11.8%), and neoplasms (n = 16, 11.1%). Of these MBMA studies, 138 (96.5%) were rated as very low quality. The average rate of compliance with PRISMA was only 51.4%. Our findings suggested that MBMA was mainly used to evaluate the efficacy and safety of drugs, with a focus on chronic diseases. The methodological and reporting quality of MBMA should be further improved. Given AMSTAR‐2 and PRISMA checklists were not specifically designed for MBMA, adapted assessment checklists for MBMA should be warranted.

中文翻译：

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基于模型的荟萃分析在药物研究中的应用和质量：系统的横截面分析和实际考虑

基于模型的荟萃分析（MBMA）可用于协助药物开发和优化临床实践中的治疗，有可能降低成本并加速药物批准。我们的目的是评估 MBMA 研究的应用和质量。我们检索了多个数据库来识别药物研究中的 MBMA。合格的 MBMA 应结合药理学概念来构建数学模型并定量检查和/或预测药物作用。总结了相关信息，以概述MBMA的应用。我们分别使用 AMSTAR-2 和 PRISMA 2020 检查表来评估纳入的 MBMA 的方法学和报告质量。总共确定了 143 项 MBMA 研究。随着时间的推移，MBMA 越来越多地用于一个或多个领域：药物发现和转化研究（n= 8, 5.6%), 药物开发决策(n= 42, 29.4%), 临床试验设计优化(n= 46, 32.2%），特殊人群用药（n= 15, 10.5%)，以及用药的合理性和安全性(n= 71, 49.7%）。纳入的MBMA涵盖了17个疾病领域，其中排名前三位的是神经系统疾病（n= 19, 13.2%), 内分泌/营养/代谢疾病(n= 17, 11.8%) 和肿瘤 (n= 16, 11.1%）。在这些 MBMA 研究中，138 项 (96.5%) 的质量被评为非常低。 PRISMA的平均依从率仅为51.4%。我们的研究结果表明，MBMA 主要用于评估药物的疗效和安全性，重点关注慢性疾病。 MBMA的方法和报告质量有待进一步提高。鉴于 AMSTAR-2 和 PRISMA 检查表不是专门为 MBMA 设计的，因此应保证针对 MBMA 进行调整的评估检查表。