A Global Perspective on Compassionate Use and Expanded Access
Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ wi...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Watson, Tom [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2017 |
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| Schlagwörter: |
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| Anmerkung: |
© Drug Information Association, Inc 2017 |
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| Übergeordnetes Werk: |
Enthalten in: Therapeutic innovation & regulatory science - [New York] : Springer Nature, 2013, 51(2017), 2 vom: März, Seite 143-145 |
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| Übergeordnetes Werk: |
volume:51 ; year:2017 ; number:2 ; month:03 ; pages:143-145 |
| Links: |
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| DOI / URN: |
10.1177/2168479017694848 |
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| Katalog-ID: |
SPR038927233 |
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| 520 | |a Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. | ||
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10.1177/2168479017694848 doi (DE-627)SPR038927233 (SPR)2168479017694848-e DE-627 ger DE-627 rakwb eng Watson, Tom verfasserin aut A Global Perspective on Compassionate Use and Expanded Access 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2017 Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. expanded access (dpeaa)DE-He213 compassionate use (dpeaa)DE-He213 managed access (dpeaa)DE-He213 drug development (dpeaa)DE-He213 named patient (dpeaa)DE-He213 Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 51(2017), 2 vom: März, Seite 143-145 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:51 year:2017 number:2 month:03 pages:143-145 https://dx.doi.org/10.1177/2168479017694848 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 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_647 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_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 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_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 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_4277 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_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 51 2017 2 03 143-145 |
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10.1177/2168479017694848 doi (DE-627)SPR038927233 (SPR)2168479017694848-e DE-627 ger DE-627 rakwb eng Watson, Tom verfasserin aut A Global Perspective on Compassionate Use and Expanded Access 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2017 Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. expanded access (dpeaa)DE-He213 compassionate use (dpeaa)DE-He213 managed access (dpeaa)DE-He213 drug development (dpeaa)DE-He213 named patient (dpeaa)DE-He213 Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 51(2017), 2 vom: März, Seite 143-145 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:51 year:2017 number:2 month:03 pages:143-145 https://dx.doi.org/10.1177/2168479017694848 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 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_647 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_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 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_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 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_4277 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_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 51 2017 2 03 143-145 |
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10.1177/2168479017694848 doi (DE-627)SPR038927233 (SPR)2168479017694848-e DE-627 ger DE-627 rakwb eng Watson, Tom verfasserin aut A Global Perspective on Compassionate Use and Expanded Access 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2017 Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. expanded access (dpeaa)DE-He213 compassionate use (dpeaa)DE-He213 managed access (dpeaa)DE-He213 drug development (dpeaa)DE-He213 named patient (dpeaa)DE-He213 Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 51(2017), 2 vom: März, Seite 143-145 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:51 year:2017 number:2 month:03 pages:143-145 https://dx.doi.org/10.1177/2168479017694848 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 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_647 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_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 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_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 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_4277 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_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 51 2017 2 03 143-145 |
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10.1177/2168479017694848 doi (DE-627)SPR038927233 (SPR)2168479017694848-e DE-627 ger DE-627 rakwb eng Watson, Tom verfasserin aut A Global Perspective on Compassionate Use and Expanded Access 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2017 Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. expanded access (dpeaa)DE-He213 compassionate use (dpeaa)DE-He213 managed access (dpeaa)DE-He213 drug development (dpeaa)DE-He213 named patient (dpeaa)DE-He213 Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 51(2017), 2 vom: März, Seite 143-145 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:51 year:2017 number:2 month:03 pages:143-145 https://dx.doi.org/10.1177/2168479017694848 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 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_647 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_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 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_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 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_4277 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_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 51 2017 2 03 143-145 |
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10.1177/2168479017694848 |
| title_sort |
global perspective on compassionate use and expanded access |
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A Global Perspective on Compassionate Use and Expanded Access |
| abstract |
Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. © Drug Information Association, Inc 2017 |
| abstractGer |
Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. © Drug Information Association, Inc 2017 |
| abstract_unstemmed |
Abstract Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational treatment should be given to a patient remain constant throughout the world, the practical and logistical realities of running an Early Access Program (EAP) differ widely globally presenting a whole range of challenges if the objective is to find solutions that are in the patients best interest and are as fair and equitable as possible. Some of the complexities can create extreme challenges for Pharma Companies looking to set up global programs, but with the right planning and strategy it is possible to overcome hurdles allowing patients to access critical treatments they desperately need. The exact design and scope of any global EAP will depend on country scope, expected demand, regulatory feasibility, the license status of the product, necessary drug pricing structure, as well as company strategy, costs, and product supply. Having worked in this space for many years, I am constantly reminded of the dramatic positive impact early access to critical treatments can have on the lives of patients and their families. I am also well aware of the potential risks that need to be well thought through and managed in order to provide access in a timely and compliant manner to the right patients and to compliment and support, rather than disrupt, traditional development pathways. © Drug Information Association, Inc 2017 |
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A Global Perspective on Compassionate Use and Expanded Access |
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| score |
7.40141 |