Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee
Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance t...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Kurtz, Jean-Emmanuel [verfasserIn] Gebski, Val [verfasserIn] Sukhin, Vladyslav [verfasserIn] Carey, Mark [verfasserIn] Kong, Iwa [verfasserIn] Glasspool, Rosalind M. [verfasserIn] Berek, Jonathan S. [verfasserIn] de Paiva Batista, Mariana [verfasserIn] Hall, Marcia [verfasserIn] Kim, Jae-Weon [verfasserIn] Yeoshoua, Effi [verfasserIn] Fujiwara, Noriko [verfasserIn] Nam, Byung-Ho [verfasserIn] Polleis, Sandra [verfasserIn] Lee, Jung-Yun [verfasserIn] Strojna, Aleksandra [verfasserIn] Farrelly, Laura [verfasserIn] Schwameis, Richard [verfasserIn] Fossati, Roldano [verfasserIn] Darlington, Anne-Sophie [verfasserIn] Lai, Chyong-Huey [verfasserIn] Wright, Alexi A. [verfasserIn] Rosenblat, Orgad [verfasserIn] Harter, Phillip [verfasserIn] Roxburgh, Patricia [verfasserIn] Chowdhury, Rahul Roy [verfasserIn] Chang, Ting-Chang [verfasserIn] Paoletti, Xavier [verfasserIn] Friedlander, Michael [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2021 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Gynecologic oncology - Orlando, Fla. : Academic Press, 1972, 161 |
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| Übergeordnetes Werk: |
volume:161 |
| DOI / URN: |
10.1016/j.ygyno.2021.02.018 |
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ELV005886872 |
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| 024 | 7 | |a 10.1016/j.ygyno.2021.02.018 |2 doi | |
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| 100 | 1 | |a Kurtz, Jean-Emmanuel |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee |
| 264 | 1 | |c 2021 | |
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| 520 | |a Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. | ||
| 650 | 4 | |a Quality of life | |
| 650 | 4 | |a PROMs | |
| 650 | 4 | |a Maintenance | |
| 650 | 4 | |a Ovarian cancer | |
| 700 | 1 | |a Gebski, Val |e verfasserin |4 aut | |
| 700 | 1 | |a Sukhin, Vladyslav |e verfasserin |4 aut | |
| 700 | 1 | |a Carey, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Kong, Iwa |e verfasserin |4 aut | |
| 700 | 1 | |a Glasspool, Rosalind M. |e verfasserin |4 aut | |
| 700 | 1 | |a Berek, Jonathan S. |e verfasserin |4 aut | |
| 700 | 1 | |a de Paiva Batista, Mariana |e verfasserin |4 aut | |
| 700 | 1 | |a Hall, Marcia |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jae-Weon |e verfasserin |4 aut | |
| 700 | 1 | |a Yeoshoua, Effi |e verfasserin |4 aut | |
| 700 | 1 | |a Fujiwara, Noriko |e verfasserin |4 aut | |
| 700 | 1 | |a Nam, Byung-Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Polleis, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Jung-Yun |e verfasserin |4 aut | |
| 700 | 1 | |a Strojna, Aleksandra |e verfasserin |4 aut | |
| 700 | 1 | |a Farrelly, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Schwameis, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Fossati, Roldano |e verfasserin |4 aut | |
| 700 | 1 | |a Darlington, Anne-Sophie |e verfasserin |4 aut | |
| 700 | 1 | |a Lai, Chyong-Huey |e verfasserin |4 aut | |
| 700 | 1 | |a Wright, Alexi A. |e verfasserin |4 aut | |
| 700 | 1 | |a Rosenblat, Orgad |e verfasserin |4 aut | |
| 700 | 1 | |a Harter, Phillip |e verfasserin |4 aut | |
| 700 | 1 | |a Roxburgh, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a Chowdhury, Rahul Roy |e verfasserin |4 aut | |
| 700 | 1 | |a Chang, Ting-Chang |e verfasserin |4 aut | |
| 700 | 1 | |a Paoletti, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Friedlander, Michael |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Gynecologic oncology |d Orlando, Fla. : Academic Press, 1972 |g 161 |h Online-Ressource |w (DE-627)266881351 |w (DE-600)1467974-7 |w (DE-576)104193735 |x 1095-6859 |7 nnns |
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10.1016/j.ygyno.2021.02.018 doi (DE-627)ELV005886872 (ELSEVIER)S0090-8258(21)00155-4 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.92 bkl Kurtz, Jean-Emmanuel verfasserin aut Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. Quality of life PROMs Maintenance Ovarian cancer Gebski, Val verfasserin aut Sukhin, Vladyslav verfasserin aut Carey, Mark verfasserin aut Kong, Iwa verfasserin aut Glasspool, Rosalind M. verfasserin aut Berek, Jonathan S. verfasserin aut de Paiva Batista, Mariana verfasserin aut Hall, Marcia verfasserin aut Kim, Jae-Weon verfasserin aut Yeoshoua, Effi verfasserin aut Fujiwara, Noriko verfasserin aut Nam, Byung-Ho verfasserin aut Polleis, Sandra verfasserin aut Lee, Jung-Yun verfasserin aut Strojna, Aleksandra verfasserin aut Farrelly, Laura verfasserin aut Schwameis, Richard verfasserin aut Fossati, Roldano verfasserin aut Darlington, Anne-Sophie verfasserin aut Lai, Chyong-Huey verfasserin aut Wright, Alexi A. verfasserin aut Rosenblat, Orgad verfasserin aut Harter, Phillip verfasserin aut Roxburgh, Patricia verfasserin aut Chowdhury, Rahul Roy verfasserin aut Chang, Ting-Chang verfasserin aut Paoletti, Xavier verfasserin aut Friedlander, Michael verfasserin aut Enthalten in Gynecologic oncology Orlando, Fla. : Academic Press, 1972 161 Online-Ressource (DE-627)266881351 (DE-600)1467974-7 (DE-576)104193735 1095-6859 nnns volume:161 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie 44.92 Gynäkologie AR 161 |
| spelling |
10.1016/j.ygyno.2021.02.018 doi (DE-627)ELV005886872 (ELSEVIER)S0090-8258(21)00155-4 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.92 bkl Kurtz, Jean-Emmanuel verfasserin aut Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. Quality of life PROMs Maintenance Ovarian cancer Gebski, Val verfasserin aut Sukhin, Vladyslav verfasserin aut Carey, Mark verfasserin aut Kong, Iwa verfasserin aut Glasspool, Rosalind M. verfasserin aut Berek, Jonathan S. verfasserin aut de Paiva Batista, Mariana verfasserin aut Hall, Marcia verfasserin aut Kim, Jae-Weon verfasserin aut Yeoshoua, Effi verfasserin aut Fujiwara, Noriko verfasserin aut Nam, Byung-Ho verfasserin aut Polleis, Sandra verfasserin aut Lee, Jung-Yun verfasserin aut Strojna, Aleksandra verfasserin aut Farrelly, Laura verfasserin aut Schwameis, Richard verfasserin aut Fossati, Roldano verfasserin aut Darlington, Anne-Sophie verfasserin aut Lai, Chyong-Huey verfasserin aut Wright, Alexi A. verfasserin aut Rosenblat, Orgad verfasserin aut Harter, Phillip verfasserin aut Roxburgh, Patricia verfasserin aut Chowdhury, Rahul Roy verfasserin aut Chang, Ting-Chang verfasserin aut Paoletti, Xavier verfasserin aut Friedlander, Michael verfasserin aut Enthalten in Gynecologic oncology Orlando, Fla. : Academic Press, 1972 161 Online-Ressource (DE-627)266881351 (DE-600)1467974-7 (DE-576)104193735 1095-6859 nnns volume:161 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie 44.92 Gynäkologie AR 161 |
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10.1016/j.ygyno.2021.02.018 doi (DE-627)ELV005886872 (ELSEVIER)S0090-8258(21)00155-4 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.92 bkl Kurtz, Jean-Emmanuel verfasserin aut Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. Quality of life PROMs Maintenance Ovarian cancer Gebski, Val verfasserin aut Sukhin, Vladyslav verfasserin aut Carey, Mark verfasserin aut Kong, Iwa verfasserin aut Glasspool, Rosalind M. verfasserin aut Berek, Jonathan S. verfasserin aut de Paiva Batista, Mariana verfasserin aut Hall, Marcia verfasserin aut Kim, Jae-Weon verfasserin aut Yeoshoua, Effi verfasserin aut Fujiwara, Noriko verfasserin aut Nam, Byung-Ho verfasserin aut Polleis, Sandra verfasserin aut Lee, Jung-Yun verfasserin aut Strojna, Aleksandra verfasserin aut Farrelly, Laura verfasserin aut Schwameis, Richard verfasserin aut Fossati, Roldano verfasserin aut Darlington, Anne-Sophie verfasserin aut Lai, Chyong-Huey verfasserin aut Wright, Alexi A. verfasserin aut Rosenblat, Orgad verfasserin aut Harter, Phillip verfasserin aut Roxburgh, Patricia verfasserin aut Chowdhury, Rahul Roy verfasserin aut Chang, Ting-Chang verfasserin aut Paoletti, Xavier verfasserin aut Friedlander, Michael verfasserin aut Enthalten in Gynecologic oncology Orlando, Fla. : Academic Press, 1972 161 Online-Ressource (DE-627)266881351 (DE-600)1467974-7 (DE-576)104193735 1095-6859 nnns volume:161 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie 44.92 Gynäkologie AR 161 |
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10.1016/j.ygyno.2021.02.018 doi (DE-627)ELV005886872 (ELSEVIER)S0090-8258(21)00155-4 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.92 bkl Kurtz, Jean-Emmanuel verfasserin aut Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. Quality of life PROMs Maintenance Ovarian cancer Gebski, Val verfasserin aut Sukhin, Vladyslav verfasserin aut Carey, Mark verfasserin aut Kong, Iwa verfasserin aut Glasspool, Rosalind M. verfasserin aut Berek, Jonathan S. verfasserin aut de Paiva Batista, Mariana verfasserin aut Hall, Marcia verfasserin aut Kim, Jae-Weon verfasserin aut Yeoshoua, Effi verfasserin aut Fujiwara, Noriko verfasserin aut Nam, Byung-Ho verfasserin aut Polleis, Sandra verfasserin aut Lee, Jung-Yun verfasserin aut Strojna, Aleksandra verfasserin aut Farrelly, Laura verfasserin aut Schwameis, Richard verfasserin aut Fossati, Roldano verfasserin aut Darlington, Anne-Sophie verfasserin aut Lai, Chyong-Huey verfasserin aut Wright, Alexi A. verfasserin aut Rosenblat, Orgad verfasserin aut Harter, Phillip verfasserin aut Roxburgh, Patricia verfasserin aut Chowdhury, Rahul Roy verfasserin aut Chang, Ting-Chang verfasserin aut Paoletti, Xavier verfasserin aut Friedlander, Michael verfasserin aut Enthalten in Gynecologic oncology Orlando, Fla. : Academic Press, 1972 161 Online-Ressource (DE-627)266881351 (DE-600)1467974-7 (DE-576)104193735 1095-6859 nnns volume:161 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie 44.92 Gynäkologie AR 161 |
| allfieldsSound |
10.1016/j.ygyno.2021.02.018 doi (DE-627)ELV005886872 (ELSEVIER)S0090-8258(21)00155-4 DE-627 ger DE-627 rda eng 610 DE-600 44.81 bkl 44.92 bkl Kurtz, Jean-Emmanuel verfasserin aut Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. Quality of life PROMs Maintenance Ovarian cancer Gebski, Val verfasserin aut Sukhin, Vladyslav verfasserin aut Carey, Mark verfasserin aut Kong, Iwa verfasserin aut Glasspool, Rosalind M. verfasserin aut Berek, Jonathan S. verfasserin aut de Paiva Batista, Mariana verfasserin aut Hall, Marcia verfasserin aut Kim, Jae-Weon verfasserin aut Yeoshoua, Effi verfasserin aut Fujiwara, Noriko verfasserin aut Nam, Byung-Ho verfasserin aut Polleis, Sandra verfasserin aut Lee, Jung-Yun verfasserin aut Strojna, Aleksandra verfasserin aut Farrelly, Laura verfasserin aut Schwameis, Richard verfasserin aut Fossati, Roldano verfasserin aut Darlington, Anne-Sophie verfasserin aut Lai, Chyong-Huey verfasserin aut Wright, Alexi A. verfasserin aut Rosenblat, Orgad verfasserin aut Harter, Phillip verfasserin aut Roxburgh, Patricia verfasserin aut Chowdhury, Rahul Roy verfasserin aut Chang, Ting-Chang verfasserin aut Paoletti, Xavier verfasserin aut Friedlander, Michael verfasserin aut Enthalten in Gynecologic oncology Orlando, Fla. : Academic Press, 1972 161 Online-Ressource (DE-627)266881351 (DE-600)1467974-7 (DE-576)104193735 1095-6859 nnns volume:161 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.81 Onkologie 44.92 Gynäkologie AR 161 |
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Enthalten in Gynecologic oncology 161 volume:161 |
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Quality of life PROMs Maintenance Ovarian cancer |
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Kurtz, Jean-Emmanuel @@aut@@ Gebski, Val @@aut@@ Sukhin, Vladyslav @@aut@@ Carey, Mark @@aut@@ Kong, Iwa @@aut@@ Glasspool, Rosalind M. @@aut@@ Berek, Jonathan S. @@aut@@ de Paiva Batista, Mariana @@aut@@ Hall, Marcia @@aut@@ Kim, Jae-Weon @@aut@@ Yeoshoua, Effi @@aut@@ Fujiwara, Noriko @@aut@@ Nam, Byung-Ho @@aut@@ Polleis, Sandra @@aut@@ Lee, Jung-Yun @@aut@@ Strojna, Aleksandra @@aut@@ Farrelly, Laura @@aut@@ Schwameis, Richard @@aut@@ Fossati, Roldano @@aut@@ Darlington, Anne-Sophie @@aut@@ Lai, Chyong-Huey @@aut@@ Wright, Alexi A. @@aut@@ Rosenblat, Orgad @@aut@@ Harter, Phillip @@aut@@ Roxburgh, Patricia @@aut@@ Chowdhury, Rahul Roy @@aut@@ Chang, Ting-Chang @@aut@@ Paoletti, Xavier @@aut@@ Friedlander, Michael @@aut@@ |
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2021-01-01T00:00:00Z |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV005886872</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230524140756.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230504s2021 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.ygyno.2021.02.018</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV005886872</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0090-8258(21)00155-4</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">DE-600</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.81</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.92</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Kurtz, Jean-Emmanuel</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2021</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. 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Kurtz, Jean-Emmanuel |
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Kurtz, Jean-Emmanuel ddc 610 bkl 44.81 bkl 44.92 misc Quality of life misc PROMs misc Maintenance misc Ovarian cancer Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee |
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610 DE-600 44.81 bkl 44.92 bkl Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee Quality of life PROMs Maintenance Ovarian cancer |
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Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee |
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Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee |
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Kurtz, Jean-Emmanuel Gebski, Val Sukhin, Vladyslav Carey, Mark Kong, Iwa Glasspool, Rosalind M. Berek, Jonathan S. de Paiva Batista, Mariana Hall, Marcia Kim, Jae-Weon Yeoshoua, Effi Fujiwara, Noriko Nam, Byung-Ho Polleis, Sandra Lee, Jung-Yun Strojna, Aleksandra Farrelly, Laura Schwameis, Richard Fossati, Roldano Darlington, Anne-Sophie Lai, Chyong-Huey Wright, Alexi A. Rosenblat, Orgad Harter, Phillip Roxburgh, Patricia Chowdhury, Rahul Roy Chang, Ting-Chang Paoletti, Xavier Friedlander, Michael |
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incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: a position paper from the gcig symptom benefit committee |
| title_auth |
Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee |
| abstract |
Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. |
| abstractGer |
Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. |
| abstract_unstemmed |
Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice. |
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| title_short |
Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee |
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Gebski, Val Sukhin, Vladyslav Carey, Mark Kong, Iwa Glasspool, Rosalind M. Berek, Jonathan S. de Paiva Batista, Mariana Hall, Marcia Kim, Jae-Weon Yeoshoua, Effi Fujiwara, Noriko Nam, Byung-Ho Polleis, Sandra Lee, Jung-Yun Strojna, Aleksandra Farrelly, Laura Schwameis, Richard Fossati, Roldano Darlington, Anne-Sophie Lai, Chyong-Huey Wright, Alexi A. Rosenblat, Orgad Harter, Phillip Roxburgh, Patricia Chowdhury, Rahul Roy Chang, Ting-Chang Paoletti, Xavier Friedlander, Michael |
| author2Str |
Gebski, Val Sukhin, Vladyslav Carey, Mark Kong, Iwa Glasspool, Rosalind M. Berek, Jonathan S. de Paiva Batista, Mariana Hall, Marcia Kim, Jae-Weon Yeoshoua, Effi Fujiwara, Noriko Nam, Byung-Ho Polleis, Sandra Lee, Jung-Yun Strojna, Aleksandra Farrelly, Laura Schwameis, Richard Fossati, Roldano Darlington, Anne-Sophie Lai, Chyong-Huey Wright, Alexi A. Rosenblat, Orgad Harter, Phillip Roxburgh, Patricia Chowdhury, Rahul Roy Chang, Ting-Chang Paoletti, Xavier Friedlander, Michael |
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| doi_str |
10.1016/j.ygyno.2021.02.018 |
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2024-07-06T19:30:10.833Z |
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