Affiliation:
1. Department of Computational Biology and Medical Big Data Shenzhen University of Advanced Technology Shenzhen China
2. Shenzhen Institute of Advanced Technology Chinese Academy of Sciences Shenzhen China
3. School of Chinese Materia Medica Tianjin University of Traditional Chinese Medicine Tianjin China
4. Drug Clinical Trial Center Peking University Third Hospital Beijing China
5. College of Public Health Science and Engineering Tianjin University of Traditional Chinese Medicine Tianjin China
6. Department of Epidemiology and Biostatistics, School of Public Health Peking University Beijing China
7. Key Laboratory of Epidemiology of Major Diseases Peking University Beijing China
Abstract
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.