Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were succes...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Lorch, Ulrike [verfasserIn] O’Kane, Martin Taubel, Jorg

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2014

Schlagwörter:	Adaptive study design Adaptive protocol Protocol writing Early phase clinical research

Anmerkung:	© Lorch et al.; licensee BioMed Central Ltd. 2014

Übergeordnetes Werk:	Enthalten in: BMC medical research methodology - London : BioMed Central, 2001, 14(2014), 1 vom: 30. Juni
Übergeordnetes Werk:	volume:14 ; year:2014 ; number:1 ; day:30 ; month:06

Links:	Volltext

DOI / URN:	10.1186/1471-2288-14-84

Katalog-ID:	SPR027368610

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spelling	10.1186/1471-2288-14-84 doi (DE-627)SPR027368610 (SPR)1471-2288-14-84-e DE-627 ger DE-627 rakwb eng Lorch, Ulrike verfasserin aut Three steps to writing adaptive study protocols in the early phase clinical development of new medicines 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Lorch et al.; licensee BioMed Central Ltd. 2014 Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. Adaptive study design (dpeaa)DE-He213 Adaptive protocol (dpeaa)DE-He213 Protocol writing (dpeaa)DE-He213 Early phase clinical research (dpeaa)DE-He213 O’Kane, Martin aut Taubel, Jorg aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 14(2014), 1 vom: 30. Juni (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:14 year:2014 number:1 day:30 month:06 https://dx.doi.org/10.1186/1471-2288-14-84 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 30 06
allfields_unstemmed	10.1186/1471-2288-14-84 doi (DE-627)SPR027368610 (SPR)1471-2288-14-84-e DE-627 ger DE-627 rakwb eng Lorch, Ulrike verfasserin aut Three steps to writing adaptive study protocols in the early phase clinical development of new medicines 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Lorch et al.; licensee BioMed Central Ltd. 2014 Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. Adaptive study design (dpeaa)DE-He213 Adaptive protocol (dpeaa)DE-He213 Protocol writing (dpeaa)DE-He213 Early phase clinical research (dpeaa)DE-He213 O’Kane, Martin aut Taubel, Jorg aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 14(2014), 1 vom: 30. Juni (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:14 year:2014 number:1 day:30 month:06 https://dx.doi.org/10.1186/1471-2288-14-84 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 30 06
allfieldsGer	10.1186/1471-2288-14-84 doi (DE-627)SPR027368610 (SPR)1471-2288-14-84-e DE-627 ger DE-627 rakwb eng Lorch, Ulrike verfasserin aut Three steps to writing adaptive study protocols in the early phase clinical development of new medicines 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Lorch et al.; licensee BioMed Central Ltd. 2014 Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. Adaptive study design (dpeaa)DE-He213 Adaptive protocol (dpeaa)DE-He213 Protocol writing (dpeaa)DE-He213 Early phase clinical research (dpeaa)DE-He213 O’Kane, Martin aut Taubel, Jorg aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 14(2014), 1 vom: 30. Juni (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:14 year:2014 number:1 day:30 month:06 https://dx.doi.org/10.1186/1471-2288-14-84 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 30 06
allfieldsSound	10.1186/1471-2288-14-84 doi (DE-627)SPR027368610 (SPR)1471-2288-14-84-e DE-627 ger DE-627 rakwb eng Lorch, Ulrike verfasserin aut Three steps to writing adaptive study protocols in the early phase clinical development of new medicines 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Lorch et al.; licensee BioMed Central Ltd. 2014 Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. Adaptive study design (dpeaa)DE-He213 Adaptive protocol (dpeaa)DE-He213 Protocol writing (dpeaa)DE-He213 Early phase clinical research (dpeaa)DE-He213 O’Kane, Martin aut Taubel, Jorg aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 14(2014), 1 vom: 30. Juni (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:14 year:2014 number:1 day:30 month:06 https://dx.doi.org/10.1186/1471-2288-14-84 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 30 06
language	English
source	Enthalten in BMC medical research methodology 14(2014), 1 vom: 30. Juni volume:14 year:2014 number:1 day:30 month:06
sourceStr	Enthalten in BMC medical research methodology 14(2014), 1 vom: 30. Juni volume:14 year:2014 number:1 day:30 month:06
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institution	findex.gbv.de
topic_facet	Adaptive study design Adaptive protocol Protocol writing Early phase clinical research
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authorswithroles_txt_mv	Lorch, Ulrike @@aut@@ O’Kane, Martin @@aut@@ Taubel, Jorg @@aut@@
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topic_title	Three steps to writing adaptive study protocols in the early phase clinical development of new medicines Adaptive study design (dpeaa)DE-He213 Adaptive protocol (dpeaa)DE-He213 Protocol writing (dpeaa)DE-He213 Early phase clinical research (dpeaa)DE-He213
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title_sort	three steps to writing adaptive study protocols in the early phase clinical development of new medicines
title_auth	Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
abstract	Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. © Lorch et al.; licensee BioMed Central Ltd. 2014
abstractGer	Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. © Lorch et al.; licensee BioMed Central Ltd. 2014
abstract_unstemmed	Abstract This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. © Lorch et al.; licensee BioMed Central Ltd. 2014
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title_short	Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
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Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

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