Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review
Identifieur interne : 001585 ( PascalFrancis/Corpus ); précédent : 001584; suivant : 001586Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review
Auteurs : Benoit You ; Hui K. Gan ; Gregory Pond ; Eric X. ChenSource :
- Journal of clinical oncology [ 0732-183X ] ; 2012.
Descripteurs français
- Pascal (Inist)
English descriptors
Abstract
Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P< .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P< .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.
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Format Inist (serveur)
| NO : | PASCAL 12-0103069 INIST |
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| ET : | Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review |
| AU : | YOU (Benoit); GAN (Hui K.); POND (Gregory); CHEN (Eric X.) |
| AF : | Princess Margaret Hospital, University Health Network/Toronto/Canada (1 aut., 2 aut., 4 aut.); McMaster University/Hamilton, Ontario/Canada (3 aut.); Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Benite; Faculté de Médecine Lyon-Sud, Oullins; Université de Lyon/Lyon/France (1 aut.); Austin Hospital, Melbourne/Victoria/Australie (2 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 2; Pp. 210-216; Bibl. 29 ref. |
| LA : | Anglais |
| EA : | Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P< .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P< .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs. |
| CC : | 002B04 |
| FD : | Tumeur maligne; Primaire; Cancérologie; Revue bibliographique; Essai randomisé contrôlé |
| FG : | Cancer |
| ED : | Malignant tumor; Primary; Cancerology; Bibliographic review; Randomized controlled trial |
| EG : | Cancer |
| SD : | Tumor maligno; Primario; Cancerología; Revista bibliográfica; Ensayo aleatorio controlado |
| LO : | INIST-20094.354000508873560180 |
| ID : | 12-0103069 |
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Pascal:12-0103069Le document en format XML
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Chen</name><affiliation><inist:fA14 i1="01"><s1>Princess Margaret Hospital, University Health Network</s1><s2>Toronto</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ></inist:fA14></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0103069</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0103069 INIST</idno><idno type="RBID">Pascal:12-0103069</idno><idno type="wicri:Area/PascalFrancis/Corpus">001585</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review</title><author><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name><affiliation><inist:fA14 i1="01"><s1>Princess Margaret Hospital, University Health Network</s1><s2>Toronto</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ></inist:fA14></affiliation><affiliation><inist:fA14 i1="03"><s1>Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Benite; Faculté de Médecine Lyon-Sud, Oullins; Université de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Gan, Hui K" sort="Gan, Hui K" uniqKey="Gan H" first="Hui K." last="Gan">Hui K. Gan</name><affiliation><inist:fA14 i1="01"><s1>Princess Margaret Hospital, University Health Network</s1><s2>Toronto</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ></inist:fA14></affiliation><affiliation><inist:fA14 i1="04"><s1>Austin Hospital, Melbourne</s1><s2>Victoria</s2><s3>AUS</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Pond, Gregory" sort="Pond, Gregory" uniqKey="Pond G" first="Gregory" last="Pond">Gregory Pond</name><affiliation><inist:fA14 i1="02"><s1>McMaster University</s1><s2>Hamilton, Ontario</s2><s3>CAN</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Chen, Eric X" sort="Chen, Eric X" uniqKey="Chen E" first="Eric X." last="Chen">Eric X. Chen</name><affiliation><inist:fA14 i1="01"><s1>Princess Margaret Hospital, University Health Network</s1><s2>Toronto</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ></inist:fA14></affiliation></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bibliographic review</term><term>Cancerology</term><term>Malignant tumor</term><term>Primary</term><term>Randomized controlled trial</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Tumeur maligne</term><term>Primaire</term><term>Cancérologie</term><term>Revue bibliographique</term><term>Essai randomisé contrôlé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P< .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P< .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0732-183X</s0></fA01><fA03 i2="1"><s0>J. clin. oncol.</s0></fA03><fA05><s2>30</s2></fA05><fA06><s2>2</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review</s1></fA08><fA11 i1="01" i2="1"><s1>YOU (Benoit)</s1></fA11><fA11 i1="02" i2="1"><s1>GAN (Hui K.)</s1></fA11><fA11 i1="03" i2="1"><s1>POND (Gregory)</s1></fA11><fA11 i1="04" i2="1"><s1>CHEN (Eric X.)</s1></fA11><fA14 i1="01"><s1>Princess Margaret Hospital, University Health Network</s1><s2>Toronto</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ></fA14><fA14 i1="02"><s1>McMaster University</s1><s2>Hamilton, Ontario</s2><s3>CAN</s3><sZ>3 aut.</sZ></fA14><fA14 i1="03"><s1>Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Benite; Faculté de Médecine Lyon-Sud, Oullins; Université de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="04"><s1>Austin Hospital, Melbourne</s1><s2>Victoria</s2><s3>AUS</s3><sZ>2 aut.</sZ></fA14><fA20><s1>210-216</s1></fA20><fA21><s1>2012</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20094</s2><s5>354000508873560180</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>29 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0103069</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P< .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P< .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.</s0></fC01><fC02 i1="01" i2="X"><s0>002B04</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Primaire</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Primary</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Primario</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Cancérologie</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Cancerology</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Cancerología</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Revue bibliographique</s0><s5>05</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Bibliographic review</s0><s5>05</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Revista bibliográfica</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Essai randomisé contrôlé</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Randomized controlled trial</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Ensayo aleatorio controlado</s0><s4>CD</s4><s5>96</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fN21><s1>079</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 12-0103069 INIST</NO><ET>Consistency in the Analysis and Reporting of Primary End Points in Oncology Randomized Controlled Trials From Registration to Publication: A Systematic Review</ET><AU>YOU (Benoit); GAN (Hui K.); POND (Gregory); CHEN (Eric X.)</AU><AF>Princess Margaret Hospital, University Health Network/Toronto/Canada (1 aut., 2 aut., 4 aut.); McMaster University/Hamilton, Ontario/Canada (3 aut.); Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Benite; Faculté de Médecine Lyon-Sud, Oullins; Université de Lyon/Lyon/France (1 aut.); Austin Hospital, Melbourne/Victoria/Australie (2 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 2; Pp. 210-216; Bibl. 29 ref.</SO><LA>Anglais</LA><EA>Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P< .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P< .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.</EA><CC>002B04</CC><FD>Tumeur maligne; Primaire; Cancérologie; Revue bibliographique; Essai randomisé contrôlé</FD><FG>Cancer</FG><ED>Malignant tumor; Primary; Cancerology; Bibliographic review; Randomized controlled trial</ED><EG>Cancer</EG><SD>Tumor maligno; Primario; Cancerología; Revista bibliográfica; Ensayo aleatorio controlado</SD><LO>INIST-20094.354000508873560180</LO><ID>12-0103069</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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