{"title":"2011-2020年加拿大卫生部批准的新药治疗价值预测:一项横断面研究","authors":"Joel Lexchin","doi":"10.1177/20542704231166620","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To examine whether a combination of three characteristics of new drugs - review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value.</p><p><strong>Design: </strong>Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020.</p><p><strong>Setting: </strong>Canada.</p><p><strong>Participants: </strong>New drugs approved by Health Canada for which therapeutic evaluations, trial outcomes and first-in-class status was available.</p><p><strong>Main outcome measures: </strong>Distribution of therapeutic value (major, moderate, little to no) depending on how many of the three characteristics were present for each drug.</p><p><strong>Results: </strong>Health Canada approved 340 drugs of which 243 had data available for analysis. If all three characteristics were present 10 out of the 20 drugs had a major therapeutic rating. Conversely if none were present only 2 drugs out of 37 had a major therapeutic rating.</p><p><strong>Conclusion: </strong>This study introduces a new evaluation method for determining whether new drugs will have major therapeutic value that appears to be more successful than relying only on the type of review that drugs receive.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 5","pages":"20542704231166620"},"PeriodicalIF":0.0000,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/58/10.1177_20542704231166620.PMC10225954.pdf","citationCount":"1","resultStr":"{\"title\":\"Prediction of therapeutic value of new drugs approved by health Canada from 2011-2020: A cross-sectional study.\",\"authors\":\"Joel Lexchin\",\"doi\":\"10.1177/20542704231166620\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To examine whether a combination of three characteristics of new drugs - review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value.</p><p><strong>Design: </strong>Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020.</p><p><strong>Setting: </strong>Canada.</p><p><strong>Participants: </strong>New drugs approved by Health Canada for which therapeutic evaluations, trial outcomes and first-in-class status was available.</p><p><strong>Main outcome measures: </strong>Distribution of therapeutic value (major, moderate, little to no) depending on how many of the three characteristics were present for each drug.</p><p><strong>Results: </strong>Health Canada approved 340 drugs of which 243 had data available for analysis. If all three characteristics were present 10 out of the 20 drugs had a major therapeutic rating. Conversely if none were present only 2 drugs out of 37 had a major therapeutic rating.</p><p><strong>Conclusion: </strong>This study introduces a new evaluation method for determining whether new drugs will have major therapeutic value that appears to be more successful than relying only on the type of review that drugs receive.</p>\",\"PeriodicalId\":17674,\"journal\":{\"name\":\"JRSM Open\",\"volume\":\"14 5\",\"pages\":\"20542704231166620\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/58/10.1177_20542704231166620.PMC10225954.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JRSM Open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/20542704231166620\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JRSM Open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20542704231166620","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Prediction of therapeutic value of new drugs approved by health Canada from 2011-2020: A cross-sectional study.
Objectives: To examine whether a combination of three characteristics of new drugs - review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value.
Design: Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020.
Setting: Canada.
Participants: New drugs approved by Health Canada for which therapeutic evaluations, trial outcomes and first-in-class status was available.
Main outcome measures: Distribution of therapeutic value (major, moderate, little to no) depending on how many of the three characteristics were present for each drug.
Results: Health Canada approved 340 drugs of which 243 had data available for analysis. If all three characteristics were present 10 out of the 20 drugs had a major therapeutic rating. Conversely if none were present only 2 drugs out of 37 had a major therapeutic rating.
Conclusion: This study introduces a new evaluation method for determining whether new drugs will have major therapeutic value that appears to be more successful than relying only on the type of review that drugs receive.
期刊介绍：
JRSM Open is a peer reviewed online-only journal that follows the open-access publishing model. It is a companion journal to the Journal of the Royal Society of Medicine. The journal publishes research papers, research letters, clinical and methodological reviews, and case reports. Our aim is to inform practice and policy making in clinical medicine. The journal has an international and multispecialty readership that includes primary care and public health professionals.
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