The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.
Identifieur interne : 002475 ( PubMed/Corpus ); précédent : 002474; suivant : 002476The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.
Auteurs : Clementine Nordon ; Helene Karcher ; Rolf H H. Groenwold ; Mikkel Zöllner Ankarfeldt ; Franz Pichler ; Helene Chevrou-Severac ; Michel Rossignol ; Adeline Abbe ; Lucien AbenhaimSource :
- Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [ 1524-4733 ] ; 2016.
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Abstract
The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.
DOI: 10.1016/j.jval.2015.09.2938
PubMed: 26797239
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.</title><author><name sortKey="Nordon, Clementine" sort="Nordon, Clementine" uniqKey="Nordon C" first="Clementine" last="Nordon">Clementine Nordon</name><affiliation><nlm:affiliation>LASER Research, Paris, France. Electronic address: clementine.nordon@la-ser.com.</nlm:affiliation></affiliation></author><author><name sortKey="Karcher, Helene" sort="Karcher, Helene" uniqKey="Karcher H" first="Helene" last="Karcher">Helene Karcher</name><affiliation><nlm:affiliation>LASER Analytica, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Groenwold, Rolf H H" sort="Groenwold, Rolf H H" uniqKey="Groenwold R" first="Rolf H H" last="Groenwold">Rolf H H. Groenwold</name><affiliation><nlm:affiliation>Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Ankarfeldt, Mikkel Zollner" sort="Ankarfeldt, Mikkel Zollner" uniqKey="Ankarfeldt M" first="Mikkel Zöllner" last="Ankarfeldt">Mikkel Zöllner Ankarfeldt</name><affiliation><nlm:affiliation>Novo Nordisk A/S, Soborg, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Pichler, Franz" sort="Pichler, Franz" uniqKey="Pichler F" first="Franz" last="Pichler">Franz Pichler</name><affiliation><nlm:affiliation>Eli Lilly and Company, Melrose Park, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Chevrou Severac, Helene" sort="Chevrou Severac, Helene" uniqKey="Chevrou Severac H" first="Helene" last="Chevrou-Severac">Helene Chevrou-Severac</name><affiliation><nlm:affiliation>Takeda Pharmaceuticals International, Glattpark-Opfikon, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Rossignol, Michel" sort="Rossignol, Michel" uniqKey="Rossignol M" first="Michel" last="Rossignol">Michel Rossignol</name><affiliation><nlm:affiliation>Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Abbe, Adeline" sort="Abbe, Adeline" uniqKey="Abbe A" first="Adeline" last="Abbe">Adeline Abbe</name><affiliation><nlm:affiliation>Sanofi R&D, Chilly Mazarin, France.</nlm:affiliation></affiliation></author><author><name sortKey="Abenhaim, Lucien" sort="Abenhaim, Lucien" uniqKey="Abenhaim L" first="Lucien" last="Abenhaim">Lucien Abenhaim</name><affiliation><nlm:affiliation>LASER Analytica, London, UK.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26797239</idno><idno type="pmid">26797239</idno><idno type="doi">10.1016/j.jval.2015.09.2938</idno><idno type="wicri:Area/PubMed/Corpus">002475</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002475</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.</title><author><name sortKey="Nordon, Clementine" sort="Nordon, Clementine" uniqKey="Nordon C" first="Clementine" last="Nordon">Clementine Nordon</name><affiliation><nlm:affiliation>LASER Research, Paris, France. Electronic address: clementine.nordon@la-ser.com.</nlm:affiliation></affiliation></author><author><name sortKey="Karcher, Helene" sort="Karcher, Helene" uniqKey="Karcher H" first="Helene" last="Karcher">Helene Karcher</name><affiliation><nlm:affiliation>LASER Analytica, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Groenwold, Rolf H H" sort="Groenwold, Rolf H H" uniqKey="Groenwold R" first="Rolf H H" last="Groenwold">Rolf H H. Groenwold</name><affiliation><nlm:affiliation>Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Ankarfeldt, Mikkel Zollner" sort="Ankarfeldt, Mikkel Zollner" uniqKey="Ankarfeldt M" first="Mikkel Zöllner" last="Ankarfeldt">Mikkel Zöllner Ankarfeldt</name><affiliation><nlm:affiliation>Novo Nordisk A/S, Soborg, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Pichler, Franz" sort="Pichler, Franz" uniqKey="Pichler F" first="Franz" last="Pichler">Franz Pichler</name><affiliation><nlm:affiliation>Eli Lilly and Company, Melrose Park, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Chevrou Severac, Helene" sort="Chevrou Severac, Helene" uniqKey="Chevrou Severac H" first="Helene" last="Chevrou-Severac">Helene Chevrou-Severac</name><affiliation><nlm:affiliation>Takeda Pharmaceuticals International, Glattpark-Opfikon, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Rossignol, Michel" sort="Rossignol, Michel" uniqKey="Rossignol M" first="Michel" last="Rossignol">Michel Rossignol</name><affiliation><nlm:affiliation>Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Abbe, Adeline" sort="Abbe, Adeline" uniqKey="Abbe A" first="Adeline" last="Abbe">Adeline Abbe</name><affiliation><nlm:affiliation>Sanofi R&D, Chilly Mazarin, France.</nlm:affiliation></affiliation></author><author><name sortKey="Abenhaim, Lucien" sort="Abenhaim, Lucien" uniqKey="Abenhaim L" first="Lucien" last="Abenhaim">Lucien Abenhaim</name><affiliation><nlm:affiliation>LASER Analytica, London, UK.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research</title><idno type="eISSN">1524-4733</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic</term><term>Drug Therapy</term><term>Health Knowledge, Attitudes, Practice</term><term>Humans</term><term>Product Surveillance, Postmarketing</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term><term>Drug Therapy</term><term>Health Knowledge, Attitudes, Practice</term><term>Humans</term><term>Product Surveillance, Postmarketing</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26797239</PMID><DateCreated><Year>2016</Year><Month>01</Month><Day>22</Day></DateCreated><DateCompleted><Year>2016</Year><Month>06</Month><Day>02</Day></DateCompleted><DateRevised><Year>2016</Year><Month>01</Month><Day>22</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1524-4733</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>1</Issue><PubDate><Year>2016</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research</Title><ISOAbbreviation>Value Health</ISOAbbreviation></Journal><ArticleTitle>The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.</ArticleTitle><Pagination><MedlinePgn>75-81</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jval.2015.09.2938</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1098-3015(15)05067-6</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.</AbstractText><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The objectives of the present narrative review were 1) to understand the historical background in which the concept of the EEG has emerged and 2) to describe the conceptualization of EEG.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A focused literature review was conducted across the gray literature and articles published in English reporting insights on the EEG concept. The identification of different "paradigms" was performed by simple inductive analysis of the documents' content.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The literature on the EEG falls into three major paradigms, in which EEG is related to 1) real-life characteristics of the health care system; 2) the method used to measure the drug's effect; and 3) a complex interaction between the drug's biological effect and contextual factors.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The third paradigm provides an opportunity to look beyond any dichotomy between "standardized" versus "real-life" characteristics of the health care system and study designs. Namely, future research will determine whether the identification of these contextual factors can help to best design randomized controlled trials that provide better estimates of drugs' effectiveness.</AbstractText><CopyrightInformation>Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nordon</LastName><ForeName>Clementine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>LASER Research, Paris, France. Electronic address: clementine.nordon@la-ser.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Karcher</LastName><ForeName>Helene</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>LASER Analytica, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Groenwold</LastName><ForeName>Rolf H H</ForeName><Initials>RH</Initials><AffiliationInfo><Affiliation>Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ankarfeldt</LastName><ForeName>Mikkel Zöllner</ForeName><Initials>MZ</Initials><AffiliationInfo><Affiliation>Novo Nordisk A/S, Soborg, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pichler</LastName><ForeName>Franz</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Eli Lilly and Company, Melrose Park, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chevrou-Severac</LastName><ForeName>Helene</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Takeda Pharmaceuticals International, Glattpark-Opfikon, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rossignol</LastName><ForeName>Michel</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abbe</LastName><ForeName>Adeline</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Sanofi R&D, Chilly Mazarin, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abenhaim</LastName><ForeName>Lucien</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>LASER Analytica, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>GetReal consortium</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>11</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Value Health</MedlineTA><NlmUniqueID>100883818</NlmUniqueID><ISSNLinking>1098-3015</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="Y">Clinical Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004358" MajorTopicYN="Y">Drug Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007722" MajorTopicYN="Y">Health Knowledge, Attitudes, Practice</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011358" MajorTopicYN="Y">Product Surveillance, Postmarketing</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="Y">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">efficacy-effectiveness gap</Keyword><Keyword MajorTopicYN="N">outcomes research</Keyword><Keyword MajorTopicYN="N">pharmaceuticals</Keyword><Keyword MajorTopicYN="N">pragmatic clinical trials</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>04</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>09</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>09</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>1</Month><Day>23</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>1</Month><Day>23</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>6</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26797239</ArticleId><ArticleId IdType="pii">S1098-3015(15)05067-6</ArticleId><ArticleId IdType="doi">10.1016/j.jval.2015.09.2938</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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