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Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study
OBJECTIVES: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017. DESIGN: Cohort study. DATA SOURCES: Journal articles listing drugs that fulfilled their cond...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2018
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931291/ https://www.ncbi.nlm.nih.gov/pubmed/29705760 http://dx.doi.org/10.1136/bmjopen-2017-020377 |
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author | Lexchin, Joel |
author_facet | Lexchin, Joel |
author_sort | Lexchin, Joel |
collection | PubMed |
description | OBJECTIVES: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017. DESIGN: Cohort study. DATA SOURCES: Journal articles listing drugs that fulfilled their conditions and received full marketing authorisation, Notice of Compliance database, Notice of Compliance with conditions website, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analysed, journal articles resulting from confirmatory studies. INTERVENTIONS: None. PRIMARY AND SECONDARY OUTCOME MEASURES: Characteristics of studies—study design (randomised controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women. RESULTS: Eleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomised controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (IQR 44–61). The median number of men per study/trial was 184 (IQR 58–514) versus women 141 (IQR 46–263). CONCLUSIONS: Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts. |
format | Online Article Text |
id | pubmed-5931291 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-59312912018-05-04 Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study Lexchin, Joel BMJ Open Health Policy OBJECTIVES: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorisation for products given a conditional approval between 1 January 1998 and 30 June 2017. DESIGN: Cohort study. DATA SOURCES: Journal articles listing drugs that fulfilled their conditions and received full marketing authorisation, Notice of Compliance database, Notice of Compliance with conditions website, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analysed, journal articles resulting from confirmatory studies. INTERVENTIONS: None. PRIMARY AND SECONDARY OUTCOME MEASURES: Characteristics of studies—study design (randomised controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women. RESULTS: Eleven companies confirmed 36 publications for 19 products (21 indications). Twenty-nine out of the 36 studies were randomised controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (IQR 44–61). The median number of men per study/trial was 184 (IQR 58–514) versus women 141 (IQR 46–263). CONCLUSIONS: Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts. BMJ Publishing Group 2018-04-28 /pmc/articles/PMC5931291/ /pubmed/29705760 http://dx.doi.org/10.1136/bmjopen-2017-020377 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Health Policy Lexchin, Joel Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
title | Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
title_full | Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
title_fullStr | Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
title_full_unstemmed | Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
title_short | Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
title_sort | quality of evidence considered by health canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study |
topic | Health Policy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931291/ https://www.ncbi.nlm.nih.gov/pubmed/29705760 http://dx.doi.org/10.1136/bmjopen-2017-020377 |
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