A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of pro...
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Autor*in:	Rosala-Hallas, Anna [verfasserIn] Gamble, Carrol Blazeby, Jane Williamson, Paula R.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Internal pilot Clinical trials Methodological research

Anmerkung:	© The Author(s). 2019

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 20(2019), 1 vom: 18. Sept.
Übergeordnetes Werk:	volume:20 ; year:2019 ; number:1 ; day:18 ; month:09

Links:	Volltext

DOI / URN:	10.1186/s13063-019-3669-9

Katalog-ID:	SPR030114101

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520			\|a Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process.
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allfields	10.1186/s13063-019-3669-9 doi (DE-627)SPR030114101 (SPR)s13063-019-3669-9-e DE-627 ger DE-627 rakwb eng Rosala-Hallas, Anna verfasserin (orcid)0000-0001-8012-9995 aut A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. Internal pilot (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Methodological research (dpeaa)DE-He213 Gamble, Carrol aut Blazeby, Jane aut Williamson, Paula R. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 18. Sept. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:18 month:09 https://dx.doi.org/10.1186/s13063-019-3669-9 kostenfrei 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_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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 20 2019 1 18 09
spelling	10.1186/s13063-019-3669-9 doi (DE-627)SPR030114101 (SPR)s13063-019-3669-9-e DE-627 ger DE-627 rakwb eng Rosala-Hallas, Anna verfasserin (orcid)0000-0001-8012-9995 aut A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. Internal pilot (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Methodological research (dpeaa)DE-He213 Gamble, Carrol aut Blazeby, Jane aut Williamson, Paula R. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 18. Sept. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:18 month:09 https://dx.doi.org/10.1186/s13063-019-3669-9 kostenfrei 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_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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 20 2019 1 18 09
allfields_unstemmed	10.1186/s13063-019-3669-9 doi (DE-627)SPR030114101 (SPR)s13063-019-3669-9-e DE-627 ger DE-627 rakwb eng Rosala-Hallas, Anna verfasserin (orcid)0000-0001-8012-9995 aut A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. Internal pilot (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Methodological research (dpeaa)DE-He213 Gamble, Carrol aut Blazeby, Jane aut Williamson, Paula R. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 18. Sept. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:18 month:09 https://dx.doi.org/10.1186/s13063-019-3669-9 kostenfrei 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_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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 20 2019 1 18 09
allfieldsGer	10.1186/s13063-019-3669-9 doi (DE-627)SPR030114101 (SPR)s13063-019-3669-9-e DE-627 ger DE-627 rakwb eng Rosala-Hallas, Anna verfasserin (orcid)0000-0001-8012-9995 aut A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. Internal pilot (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Methodological research (dpeaa)DE-He213 Gamble, Carrol aut Blazeby, Jane aut Williamson, Paula R. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 18. Sept. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:18 month:09 https://dx.doi.org/10.1186/s13063-019-3669-9 kostenfrei 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_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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 20 2019 1 18 09
allfieldsSound	10.1186/s13063-019-3669-9 doi (DE-627)SPR030114101 (SPR)s13063-019-3669-9-e DE-627 ger DE-627 rakwb eng Rosala-Hallas, Anna verfasserin (orcid)0000-0001-8012-9995 aut A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. Internal pilot (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Methodological research (dpeaa)DE-He213 Gamble, Carrol aut Blazeby, Jane aut Williamson, Paula R. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 18. Sept. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:18 month:09 https://dx.doi.org/10.1186/s13063-019-3669-9 kostenfrei 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_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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 20 2019 1 18 09
language	English
source	Enthalten in Trials 20(2019), 1 vom: 18. Sept. volume:20 year:2019 number:1 day:18 month:09
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Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. 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author	Rosala-Hallas, Anna
spellingShingle	Rosala-Hallas, Anna misc Internal pilot misc Clinical trials misc Methodological research A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
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topic_title	A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials Internal pilot (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Methodological research (dpeaa)DE-He213
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title	A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
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title_sort	review of current practice in the design and assessment of internal pilots in uk nihr clinical trials
title_auth	A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
abstract	Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. © The Author(s). 2019
abstractGer	Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. © The Author(s). 2019
abstract_unstemmed	Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process. © The Author(s). 2019
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title_short	A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
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Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. 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A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

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