[Rethinking clinical research in surgical oncology. From comic opera to quality control].
Identifieur interne : 000E50 ( Ncbi/Merge ); précédent : 000E49; suivant : 000E51[Rethinking clinical research in surgical oncology. From comic opera to quality control].
Auteurs : Serge Evrard [France]Source :
- Bulletin du cancer ; 2016.
Abstract
The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.
DOI: 10.1016/j.bulcan.2015.10.006
PubMed: 26610367
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From comic opera to quality control].</title><author><name sortKey="Evrard, Serge" sort="Evrard, Serge" uniqKey="Evrard S" first="Serge" last="Evrard">Serge Evrard</name><affiliation wicri:level="4"><nlm:affiliation>Université de Bordeaux, institut Bergonié, Inserm U1029, 229, cours de l'Argonne, 33076 Bordeaux, France. Electronic address: s.evrard@bordeaux.unicancer.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Université de Bordeaux, institut Bergonié, Inserm U1029, 229, cours de l'Argonne, 33076 Bordeaux</wicri:regionArea><placeName><region type="region" nuts="2">Aquitaine-Limousin-Poitou-Charentes</region><region type="old region" nuts="2">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName><orgName type="university">Université de Bordeaux</orgName></affiliation></author></analytic><series><title level="j">Bulletin du cancer</title><idno type="e-ISSN">1769-6917</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="In-Data-Review"><PMID Version="1">26610367</PMID><DateCreated><Year>2016</Year><Month>02</Month><Day>02</Day></DateCreated><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1769-6917</ISSN><JournalIssue CitedMedium="Internet"><Volume>103</Volume><Issue>1</Issue><PubDate><Year>2016</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Bulletin du cancer</Title><ISOAbbreviation>Bull Cancer</ISOAbbreviation></Journal><ArticleTitle>[Rethinking clinical research in surgical oncology. From comic opera to quality control].</ArticleTitle><Pagination><MedlinePgn>87-95</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.bulcan.2015.10.006</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0007-4551(15)00312-4</ELocationID><Abstract><AbstractText>The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.</AbstractText><CopyrightInformation>Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Evrard</LastName><ForeName>Serge</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Université de Bordeaux, institut Bergonié, Inserm U1029, 229, cours de l'Argonne, 33076 Bordeaux, France. Electronic address: s.evrard@bordeaux.unicancer.fr.</Affiliation></AffiliationInfo></Author></AuthorList><Language>fre</Language><PublicationTypeList><PublicationType UI="D004740">English Abstract</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><VernacularTitle>Repenser la recherche clinique en chirurgie oncologique. De l'opéra-comique au contrôle qualité.</VernacularTitle><ArticleDate DateType="Electronic"><Year>2015</Year><Month>11</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>France</Country><MedlineTA>Bull Cancer</MedlineTA><NlmUniqueID>0072416</NlmUniqueID><ISSNLinking>0007-4551</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Chirurgie oncologique</Keyword><Keyword MajorTopicYN="N">Clinical research</Keyword><Keyword MajorTopicYN="N">Essai pragmatique</Keyword><Keyword MajorTopicYN="N">Essai prospectif non randomisé</Keyword><Keyword MajorTopicYN="N">Essai randomisé</Keyword><Keyword MajorTopicYN="N">Non-randomised prospective study</Keyword><Keyword MajorTopicYN="N">Pragmatic trial</Keyword><Keyword MajorTopicYN="N">Randomised control trial</Keyword><Keyword MajorTopicYN="N">Recherche clinique</Keyword><Keyword MajorTopicYN="N">Surgical oncology</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>10</Month><Day>2</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>10</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2015</Year><Month>11</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>11</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>11</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>11</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26610367</ArticleId><ArticleId IdType="pii">S0007-4551(15)00312-4</ArticleId><ArticleId IdType="doi">10.1016/j.bulcan.2015.10.006</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>France</li></country><region><li>Aquitaine</li><li>Aquitaine-Limousin-Poitou-Charentes</li></region><settlement><li>Bordeaux</li></settlement><orgName><li>Université de Bordeaux</li></orgName></list><tree><country name="France"><region name="Aquitaine-Limousin-Poitou-Charentes"><name sortKey="Evrard, Serge" sort="Evrard, Serge" uniqKey="Evrard S" first="Serge" last="Evrard">Serge Evrard</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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