Assessing Patient Participation Burden Based on Protocol Design Characteristics

Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presen...
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Autor*in:	Getz, Kenneth [verfasserIn] Sethuraman, Venkat [verfasserIn] Rine, Jessica [verfasserIn] Peña, Yaritza [verfasserIn] Ramanathan, Sharma [verfasserIn] Stergiopoulos, Stella [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	study volunteer burden patient participation burden protocol design complexity protocol design optimization

Übergeordnetes Werk:	Enthalten in: Therapeutic innovation & regulatory science - [New York] : Springer Nature, 2013, 54(2020), 3 vom: 06. Jan., Seite 598-604
Übergeordnetes Werk:	volume:54 ; year:2020 ; number:3 ; day:06 ; month:01 ; pages:598-604

Links:	Volltext

DOI / URN:	10.1007/s43441-019-00092-4

Katalog-ID:	SPR039303381

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520			\|a Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement.
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allfields	10.1007/s43441-019-00092-4 doi (DE-627)SPR039303381 (DE-599)SPRs43441-019-00092-4-e (SPR)s43441-019-00092-4-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.38 bkl Getz, Kenneth verfasserin aut Assessing Patient Participation Burden Based on Protocol Design Characteristics 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement. study volunteer burden (dpeaa)DE-He213 patient participation burden (dpeaa)DE-He213 protocol design complexity (dpeaa)DE-He213 protocol design optimization (dpeaa)DE-He213 Sethuraman, Venkat verfasserin aut Rine, Jessica verfasserin aut Peña, Yaritza verfasserin aut Ramanathan, Sharma verfasserin aut Stergiopoulos, Stella verfasserin aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 54(2020), 3 vom: 06. Jan., Seite 598-604 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:54 year:2020 number:3 day:06 month:01 pages:598-604 https://dx.doi.org/10.1007/s43441-019-00092-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 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_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.38 ASE AR 54 2020 3 06 01 598-604
spelling	10.1007/s43441-019-00092-4 doi (DE-627)SPR039303381 (DE-599)SPRs43441-019-00092-4-e (SPR)s43441-019-00092-4-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.38 bkl Getz, Kenneth verfasserin aut Assessing Patient Participation Burden Based on Protocol Design Characteristics 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement. study volunteer burden (dpeaa)DE-He213 patient participation burden (dpeaa)DE-He213 protocol design complexity (dpeaa)DE-He213 protocol design optimization (dpeaa)DE-He213 Sethuraman, Venkat verfasserin aut Rine, Jessica verfasserin aut Peña, Yaritza verfasserin aut Ramanathan, Sharma verfasserin aut Stergiopoulos, Stella verfasserin aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 54(2020), 3 vom: 06. Jan., Seite 598-604 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:54 year:2020 number:3 day:06 month:01 pages:598-604 https://dx.doi.org/10.1007/s43441-019-00092-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 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_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.38 ASE AR 54 2020 3 06 01 598-604
allfields_unstemmed	10.1007/s43441-019-00092-4 doi (DE-627)SPR039303381 (DE-599)SPRs43441-019-00092-4-e (SPR)s43441-019-00092-4-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.38 bkl Getz, Kenneth verfasserin aut Assessing Patient Participation Burden Based on Protocol Design Characteristics 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement. study volunteer burden (dpeaa)DE-He213 patient participation burden (dpeaa)DE-He213 protocol design complexity (dpeaa)DE-He213 protocol design optimization (dpeaa)DE-He213 Sethuraman, Venkat verfasserin aut Rine, Jessica verfasserin aut Peña, Yaritza verfasserin aut Ramanathan, Sharma verfasserin aut Stergiopoulos, Stella verfasserin aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 54(2020), 3 vom: 06. Jan., Seite 598-604 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:54 year:2020 number:3 day:06 month:01 pages:598-604 https://dx.doi.org/10.1007/s43441-019-00092-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 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_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.38 ASE AR 54 2020 3 06 01 598-604
allfieldsGer	10.1007/s43441-019-00092-4 doi (DE-627)SPR039303381 (DE-599)SPRs43441-019-00092-4-e (SPR)s43441-019-00092-4-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.38 bkl Getz, Kenneth verfasserin aut Assessing Patient Participation Burden Based on Protocol Design Characteristics 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement. study volunteer burden (dpeaa)DE-He213 patient participation burden (dpeaa)DE-He213 protocol design complexity (dpeaa)DE-He213 protocol design optimization (dpeaa)DE-He213 Sethuraman, Venkat verfasserin aut Rine, Jessica verfasserin aut Peña, Yaritza verfasserin aut Ramanathan, Sharma verfasserin aut Stergiopoulos, Stella verfasserin aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 54(2020), 3 vom: 06. Jan., Seite 598-604 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:54 year:2020 number:3 day:06 month:01 pages:598-604 https://dx.doi.org/10.1007/s43441-019-00092-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 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_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.38 ASE AR 54 2020 3 06 01 598-604
allfieldsSound	10.1007/s43441-019-00092-4 doi (DE-627)SPR039303381 (DE-599)SPRs43441-019-00092-4-e (SPR)s43441-019-00092-4-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.38 bkl Getz, Kenneth verfasserin aut Assessing Patient Participation Burden Based on Protocol Design Characteristics 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement. study volunteer burden (dpeaa)DE-He213 patient participation burden (dpeaa)DE-He213 protocol design complexity (dpeaa)DE-He213 protocol design optimization (dpeaa)DE-He213 Sethuraman, Venkat verfasserin aut Rine, Jessica verfasserin aut Peña, Yaritza verfasserin aut Ramanathan, Sharma verfasserin aut Stergiopoulos, Stella verfasserin aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 54(2020), 3 vom: 06. Jan., Seite 598-604 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:54 year:2020 number:3 day:06 month:01 pages:598-604 https://dx.doi.org/10.1007/s43441-019-00092-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 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_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.38 ASE AR 54 2020 3 06 01 598-604
language	English
source	Enthalten in Therapeutic innovation & regulatory science 54(2020), 3 vom: 06. Jan., Seite 598-604 volume:54 year:2020 number:3 day:06 month:01 pages:598-604
sourceStr	Enthalten in Therapeutic innovation & regulatory science 54(2020), 3 vom: 06. Jan., Seite 598-604 volume:54 year:2020 number:3 day:06 month:01 pages:598-604
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	study volunteer burden patient participation burden protocol design complexity protocol design optimization
dewey-raw	610
isfreeaccess_bool	false
container_title	Therapeutic innovation & regulatory science
authorswithroles_txt_mv	Getz, Kenneth @@aut@@ Sethuraman, Venkat @@aut@@ Rine, Jessica @@aut@@ Peña, Yaritza @@aut@@ Ramanathan, Sharma @@aut@@ Stergiopoulos, Stella @@aut@@
publishDateDaySort_date	2020-01-06T00:00:00Z
hierarchy_top_id	739896415
dewey-sort	3610
id	SPR039303381
language_de	englisch
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Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. 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author	Getz, Kenneth
spellingShingle	Getz, Kenneth ddc 610 bkl 44.38 misc study volunteer burden misc patient participation burden misc protocol design complexity misc protocol design optimization Assessing Patient Participation Burden Based on Protocol Design Characteristics
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topic_title	610 ASE 44.38 bkl Assessing Patient Participation Burden Based on Protocol Design Characteristics study volunteer burden (dpeaa)DE-He213 patient participation burden (dpeaa)DE-He213 protocol design complexity (dpeaa)DE-He213 protocol design optimization (dpeaa)DE-He213
topic	ddc 610 bkl 44.38 misc study volunteer burden misc patient participation burden misc protocol design complexity misc protocol design optimization
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title	Assessing Patient Participation Burden Based on Protocol Design Characteristics
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title_full	Assessing Patient Participation Burden Based on Protocol Design Characteristics
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author_browse	Getz, Kenneth Sethuraman, Venkat Rine, Jessica Peña, Yaritza Ramanathan, Sharma Stergiopoulos, Stella
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title_sort	assessing patient participation burden based on protocol design characteristics
title_auth	Assessing Patient Participation Burden Based on Protocol Design Characteristics
abstract	Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement.
abstractGer	Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement.
abstract_unstemmed	Background Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions The study results suggest a new and viable approach to optimize protocol design and improve patient engagement.
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title_short	Assessing Patient Participation Burden Based on Protocol Design Characteristics
url	https://dx.doi.org/10.1007/s43441-019-00092-4
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author2	Sethuraman, Venkat Rine, Jessica Peña, Yaritza Ramanathan, Sharma Stergiopoulos, Stella
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up_date	2024-07-03T23:13:08.834Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR039303381</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519083548.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2020 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s43441-019-00092-4</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR039303381</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)SPRs43441-019-00092-4-e</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s43441-019-00092-4-e</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">rakwb</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">ASE</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.38</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Getz, Kenneth</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Assessing Patient Participation Burden Based on Protocol Design Characteristics</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</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 Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden–derived from aggregating mean perceived burden ratings for individual procedures–and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross–sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. 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