The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.
Identifieur interne : 001599 ( PubMed/Checkpoint ); précédent : 001598; suivant : 001600The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.
Auteurs : Clementine Nordon [France] ; Helene Karcher [Royaume-Uni] ; Rolf H H. Groenwold [Pays-Bas] ; Mikkel Zöllner Ankarfeldt [Danemark] ; Franz Pichler [Australie] ; Helene Chevrou-Severac [Suisse] ; Michel Rossignol [Canada] ; Adeline Abbe [France] ; Lucien Abenhaim [Royaume-Uni]Source :
- Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [ 1524-4733 ] ; 2016.
Descripteurs français
- KwdFr :
- MESH :
English descriptors
- KwdEn :
- MESH :
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
Affiliations:
- Australie, Canada, Danemark, France, Pays-Bas, Royaume-Uni, Suisse
- Angleterre, Grand Londres, Québec, Utrecht (province), Île-de-France
- Londres, Montréal, Paris, Utrecht
- Université McGill
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Links to Exploration step
pubmed:26797239Le document en format XML
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Electronic address: clementine.nordon@la-ser.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>LASER Research, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Karcher, Helene" sort="Karcher, Helene" uniqKey="Karcher H" first="Helene" last="Karcher">Helene Karcher</name><affiliation wicri:level="3"><nlm:affiliation>LASER Analytica, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>LASER Analytica, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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 wicri:level="3"><nlm:affiliation>Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></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 wicri:level="1"><nlm:affiliation>Novo Nordisk A/S, Soborg, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Novo Nordisk A/S, Soborg</wicri:regionArea><wicri:noRegion>Soborg</wicri:noRegion></affiliation></author><author><name sortKey="Pichler, Franz" sort="Pichler, Franz" uniqKey="Pichler F" first="Franz" last="Pichler">Franz Pichler</name><affiliation wicri:level="1"><nlm:affiliation>Eli Lilly and Company, Melrose Park, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Eli Lilly and Company, Melrose Park</wicri:regionArea><wicri:noRegion>Melrose Park</wicri:noRegion></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 wicri:level="1"><nlm:affiliation>Takeda Pharmaceuticals International, Glattpark-Opfikon, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Takeda Pharmaceuticals International, Glattpark-Opfikon</wicri:regionArea><wicri:noRegion>Glattpark-Opfikon</wicri:noRegion></affiliation></author><author><name sortKey="Rossignol, Michel" sort="Rossignol, Michel" uniqKey="Rossignol M" first="Michel" last="Rossignol">Michel Rossignol</name><affiliation wicri:level="4"><nlm:affiliation>Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec</wicri:regionArea><orgName type="university">Université McGill</orgName><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Abbe, Adeline" sort="Abbe, Adeline" uniqKey="Abbe A" first="Adeline" last="Abbe">Adeline Abbe</name><affiliation wicri:level="1"><nlm:affiliation>Sanofi R&D, Chilly Mazarin, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sanofi R&D, Chilly Mazarin</wicri:regionArea><wicri:noRegion>Chilly Mazarin</wicri:noRegion><wicri:noRegion>Chilly Mazarin</wicri:noRegion></affiliation></author><author><name sortKey="Abenhaim, Lucien" sort="Abenhaim, Lucien" uniqKey="Abenhaim L" first="Lucien" last="Abenhaim">Lucien Abenhaim</name><affiliation wicri:level="3"><nlm:affiliation>LASER Analytica, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>LASER Analytica, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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="KwdFr" xml:lang="fr"><term>Connaissances, attitudes et pratiques en santé</term><term>Essais cliniques comme sujet</term><term>Humains</term><term>Résultat thérapeutique</term><term>Surveillance post-commercialisation des produits de santé</term><term>Traitement médicamenteux</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><keywords scheme="MESH" xml:lang="fr"><term>Connaissances, attitudes et pratiques en santé</term><term>Essais cliniques comme sujet</term><term>Humains</term><term>Résultat thérapeutique</term><term>Surveillance post-commercialisation des produits de santé</term><term>Traitement médicamenteux</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 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(province)</li><li>Île-de-France</li></region><settlement><li>Londres</li><li>Montréal</li><li>Paris</li><li>Utrecht</li></settlement><orgName><li>Université McGill</li></orgName></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Nordon, Clementine" sort="Nordon, Clementine" uniqKey="Nordon C" first="Clementine" last="Nordon">Clementine Nordon</name></region><name sortKey="Abbe, Adeline" sort="Abbe, Adeline" uniqKey="Abbe A" first="Adeline" last="Abbe">Adeline Abbe</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Karcher, Helene" sort="Karcher, Helene" uniqKey="Karcher H" first="Helene" last="Karcher">Helene Karcher</name></region><name sortKey="Abenhaim, Lucien" sort="Abenhaim, Lucien" uniqKey="Abenhaim L" first="Lucien" last="Abenhaim">Lucien Abenhaim</name></country><country name="Pays-Bas"><region name="Utrecht (province)"><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></region></country><country name="Danemark"><noRegion><name sortKey="Ankarfeldt, Mikkel Zollner" sort="Ankarfeldt, Mikkel Zollner" uniqKey="Ankarfeldt M" first="Mikkel Zöllner" last="Ankarfeldt">Mikkel Zöllner Ankarfeldt</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Pichler, Franz" sort="Pichler, Franz" uniqKey="Pichler F" first="Franz" last="Pichler">Franz Pichler</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Chevrou Severac, Helene" sort="Chevrou Severac, Helene" uniqKey="Chevrou Severac H" first="Helene" last="Chevrou-Severac">Helene Chevrou-Severac</name></noRegion></country><country name="Canada"><region name="Québec"><name sortKey="Rossignol, Michel" sort="Rossignol, Michel" uniqKey="Rossignol M" first="Michel" last="Rossignol">Michel Rossignol</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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