{"title":"药物和器械开发中基于模型的元分析及数据共享的附加价值","authors":"T. Muka","doi":"10.54920/scto.2022.rawatch.7.28","DOIUrl":null,"url":null,"abstract":"Meta-analysis, the highest level of evidence, is a statistical analysis that includes a mathematical combination of the results from different studies. Meta-analysis can be a subset of systematic review or the pooling of results from individual patient data (IPD). The number of published systematic reviews and meta-analyses has grown exponentially in recent years: a search in PubMed showed that around 1,600 systematic review and meta-analysis publications were indexed in 2000 compared to over 35,000 in 2020. And this upward trend is projected to continue. With the new regulatory landscape making the development and maintenance of clinical evaluation reports (CERs) a priority for drug and device manufacturers, methodologically sound meta-analysis will be key to guiding strategic drug and device development decisions.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"75 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Model-based meta-analysis in drug and device development and the added value of data sharing\",\"authors\":\"T. Muka\",\"doi\":\"10.54920/scto.2022.rawatch.7.28\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Meta-analysis, the highest level of evidence, is a statistical analysis that includes a mathematical combination of the results from different studies. Meta-analysis can be a subset of systematic review or the pooling of results from individual patient data (IPD). The number of published systematic reviews and meta-analyses has grown exponentially in recent years: a search in PubMed showed that around 1,600 systematic review and meta-analysis publications were indexed in 2000 compared to over 35,000 in 2020. And this upward trend is projected to continue. With the new regulatory landscape making the development and maintenance of clinical evaluation reports (CERs) a priority for drug and device manufacturers, methodologically sound meta-analysis will be key to guiding strategic drug and device development decisions.\",\"PeriodicalId\":419230,\"journal\":{\"name\":\"Regulatory Affairs Watch\",\"volume\":\"75 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Regulatory Affairs Watch\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.54920/scto.2022.rawatch.7.28\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Affairs Watch","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.54920/scto.2022.rawatch.7.28","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Model-based meta-analysis in drug and device development and the added value of data sharing
Meta-analysis, the highest level of evidence, is a statistical analysis that includes a mathematical combination of the results from different studies. Meta-analysis can be a subset of systematic review or the pooling of results from individual patient data (IPD). The number of published systematic reviews and meta-analyses has grown exponentially in recent years: a search in PubMed showed that around 1,600 systematic review and meta-analysis publications were indexed in 2000 compared to over 35,000 in 2020. And this upward trend is projected to continue. With the new regulatory landscape making the development and maintenance of clinical evaluation reports (CERs) a priority for drug and device manufacturers, methodologically sound meta-analysis will be key to guiding strategic drug and device development decisions.
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