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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 Janu...

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Detalles Bibliográficos
Autor principal: Lexchin, Joel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225954/
https://www.ncbi.nlm.nih.gov/pubmed/37255526
http://dx.doi.org/10.1177/20542704231166620
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author Lexchin, Joel
author_facet Lexchin, Joel
author_sort Lexchin, Joel
collection PubMed
description 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.
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spelling pubmed-102259542023-05-30 Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study Lexchin, Joel JRSM Open Research Paper 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. SAGE Publications 2023-05-24 /pmc/articles/PMC10225954/ /pubmed/37255526 http://dx.doi.org/10.1177/20542704231166620 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Research Paper
Lexchin, Joel
Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study
title Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study
title_full Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study
title_fullStr Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study
title_full_unstemmed Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study
title_short Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study
title_sort prediction of therapeutic value of new drugs approved by health canada from 2011−2020: a cross-sectional study
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225954/
https://www.ncbi.nlm.nih.gov/pubmed/37255526
http://dx.doi.org/10.1177/20542704231166620
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