Dissemination of trial results to participants in Phase III pragmatic clinical trials: an audit of trial investigators intentions

Katie Gillies; Mohammad Raza; Hanne Bruhn

doi:10.1136/bmjopen-2019-035730

Dissemination of trial results to participants in Phase III pragmatic clinical trials: an audit of trial investigators intentions

Katie Gillies^* (Corresponding Author), Mohammad Raza, Hanne Bruhn

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

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Abstract

Objective
To determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.

Design
Audit of records.

Setting
Phase III clinical trials registered on the UK’s research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.

Main outcome measures
Proportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.

Results
Out of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.

Conclusions
Reported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.

Original language	English
Article number	e035730
Number of pages	8
Journal	BMJ Open
Volume	10
Issue number	1
Early online date	2 Feb 2020
DOIs	https://doi.org/10.1136/bmjopen-2019-035730
Publication status	Published - 2020

Bibliographical note

Acknowledgments

We thank Bill Davidson (former joint Head of Policy for the Health Research Authority (HRA)) and colleagues at the HRA for enabling access to IRAS data, providing access to HARP and commenting on progress and initial results of the study (specifically, Juliet Tizzard and Jim Elliott). Thanks also to Graeme Maclennan for analysis advice and all members of the RECAP study team (Marion Campbell, Vikki Entwistle, Rosemary Humphreys, Sandra Jayacodi and Peter Knapp).
Funding HB was funded by the Academy of Medical Sciences (SBF002\1014) and KG was funded by the Medical Research Council (MR/L01193X/1). MZR was unfunded and conducted this work as part of a Masters in Public Health degree.

Keywords

clinical audit
clinical trials
medical ethics

Access to Document

10.1136/bmjopen-2019-035730Licence: CC BY

Raza_DisseminationofTrialResults_VOR
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Final published version, 444 KBLicence: CC BY

Cite this

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title = "Dissemination of trial results to participants in Phase III pragmatic clinical trials: an audit of trial investigators intentions",

abstract = "Objective To determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.Design Audit of records.Setting Phase III clinical trials registered on the UK{\textquoteright}s research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.Main outcome measures Proportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.Results Out of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.Conclusions Reported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.",

keywords = "clinical audit, clinical trials, medical ethics",

author = "Katie Gillies and Mohammad Raza and Hanne Bruhn",

note = "Acknowledgments We thank Bill Davidson (former joint Head of Policy for the Health Research Authority (HRA)) and colleagues at the HRA for enabling access to IRAS data, providing access to HARP and commenting on progress and initial results of the study (specifically, Juliet Tizzard and Jim Elliott). Thanks also to Graeme Maclennan for analysis advice and all members of the RECAP study team (Marion Campbell, Vikki Entwistle, Rosemary Humphreys, Sandra Jayacodi and Peter Knapp). Funding HB was funded by the Academy of Medical Sciences (SBF002\1014) and KG was funded by the Medical Research Council (MR/L01193X/1). MZR was unfunded and conducted this work as part of a Masters in Public Health degree.",

year = "2020",

doi = "10.1136/bmjopen-2019-035730",

language = "English",

volume = "10",

journal = "BMJ Open",

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T1 - Dissemination of trial results to participants in Phase III pragmatic clinical trials

T2 - an audit of trial investigators intentions

AU - Gillies, Katie

AU - Raza, Mohammad

AU - Bruhn, Hanne

N1 - Acknowledgments We thank Bill Davidson (former joint Head of Policy for the Health Research Authority (HRA)) and colleagues at the HRA for enabling access to IRAS data, providing access to HARP and commenting on progress and initial results of the study (specifically, Juliet Tizzard and Jim Elliott). Thanks also to Graeme Maclennan for analysis advice and all members of the RECAP study team (Marion Campbell, Vikki Entwistle, Rosemary Humphreys, Sandra Jayacodi and Peter Knapp). Funding HB was funded by the Academy of Medical Sciences (SBF002\1014) and KG was funded by the Medical Research Council (MR/L01193X/1). MZR was unfunded and conducted this work as part of a Masters in Public Health degree.

PY - 2020

Y1 - 2020

N2 - Objective To determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.Design Audit of records.Setting Phase III clinical trials registered on the UK’s research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.Main outcome measures Proportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.Results Out of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.Conclusions Reported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.

AB - Objective To determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.Design Audit of records.Setting Phase III clinical trials registered on the UK’s research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.Main outcome measures Proportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.Results Out of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.Conclusions Reported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.

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KW - medical ethics

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DO - 10.1136/bmjopen-2019-035730

M3 - Article

SN - 2044-6055

VL - 10

JO - BMJ Open

JF - BMJ Open

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M1 - e035730

ER -

Dissemination of trial results to participants in Phase III pragmatic clinical trials: an audit of trial investigators intentions

Abstract

Bibliographical note

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Kate Gillies

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Dissemination of trial results to participants in Phase III pragmatic clinical trials: an audit of trial investigators intentions

Abstract

Bibliographical note

Keywords

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Kate Gillies

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