Cargando…

Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement

BACKGROUND: Easy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a l...

Descripción completa

Detalles Bibliográficos
Autores principales: Penlington, Michael, Silverman, Harold, Vasudevan, Ajithkumar, Pavithran, Priya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744300/
https://www.ncbi.nlm.nih.gov/pubmed/33113147
http://dx.doi.org/10.1007/s40290-020-00359-4
_version_ 1783624408803311616
author Penlington, Michael
Silverman, Harold
Vasudevan, Ajithkumar
Pavithran, Priya
author_facet Penlington, Michael
Silverman, Harold
Vasudevan, Ajithkumar
Pavithran, Priya
author_sort Penlington, Michael
collection PubMed
description BACKGROUND: Easy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Today, however, little is known about the extent to which PLSs are written and are available to the general public. OBJECTIVES: This preliminary study assessed (i) 20 top pharmaceutical companies’ positions on improving transparency and commitment to disclosing trial result summaries in an easy-to-understand format and (ii) the availability of such summaries in the public domain and the ease of locating them via general web searches. METHODS: The availability of PLSs in the public domain was estimated based on the number of EudraCT technical result summaries in four disease areas: chronic obstructive pulmonary disease, asthma, meningitis, and influenza. The likelihood of PLSs being easy to find through internet search engine queries by members of the public was assessed using Google. RESULTS: All 20 sponsors had committed to improve clinical trial transparency, 17 committed to sharing PLSs with trial participants, and 14 had at least one PLS available in the public domain. A total of 99 clinical studies in these four disease areas had technical summaries posted on EudraCT between 1 January 2017 and 30 June 2020. Of these 99, 14 studies had PLSs in the public domain. A total of 12 of 14 PLSs were directly captured by search engine. However, the sponsor trial identifier or EudraCT number had to be included in the search term to locate them. Generic search terms resulted in large volumes of non-relevant results. CONCLUSION: Despite the progressive movement towards clinical trial transparency, easily accessible PLSs on clinical trials are currently scarce. The provision of a European mandate and framework for non-technical result summaries by Regulation (EU) 536/2014 will be a major step to bring about positive change.
format Online
Article
Text
id pubmed-7744300
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-77443002020-12-17 Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement Penlington, Michael Silverman, Harold Vasudevan, Ajithkumar Pavithran, Priya Pharmaceut Med Short Communication BACKGROUND: Easy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Today, however, little is known about the extent to which PLSs are written and are available to the general public. OBJECTIVES: This preliminary study assessed (i) 20 top pharmaceutical companies’ positions on improving transparency and commitment to disclosing trial result summaries in an easy-to-understand format and (ii) the availability of such summaries in the public domain and the ease of locating them via general web searches. METHODS: The availability of PLSs in the public domain was estimated based on the number of EudraCT technical result summaries in four disease areas: chronic obstructive pulmonary disease, asthma, meningitis, and influenza. The likelihood of PLSs being easy to find through internet search engine queries by members of the public was assessed using Google. RESULTS: All 20 sponsors had committed to improve clinical trial transparency, 17 committed to sharing PLSs with trial participants, and 14 had at least one PLS available in the public domain. A total of 99 clinical studies in these four disease areas had technical summaries posted on EudraCT between 1 January 2017 and 30 June 2020. Of these 99, 14 studies had PLSs in the public domain. A total of 12 of 14 PLSs were directly captured by search engine. However, the sponsor trial identifier or EudraCT number had to be included in the search term to locate them. Generic search terms resulted in large volumes of non-relevant results. CONCLUSION: Despite the progressive movement towards clinical trial transparency, easily accessible PLSs on clinical trials are currently scarce. The provision of a European mandate and framework for non-technical result summaries by Regulation (EU) 536/2014 will be a major step to bring about positive change. Springer International Publishing 2020-10-28 2020 /pmc/articles/PMC7744300/ /pubmed/33113147 http://dx.doi.org/10.1007/s40290-020-00359-4 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Short Communication
Penlington, Michael
Silverman, Harold
Vasudevan, Ajithkumar
Pavithran, Priya
Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement
title Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement
title_full Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement
title_fullStr Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement
title_full_unstemmed Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement
title_short Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement
title_sort plain language summaries of clinical trial results: a preliminary study to assess availability of easy-to-understand summaries and approaches to improving public engagement
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744300/
https://www.ncbi.nlm.nih.gov/pubmed/33113147
http://dx.doi.org/10.1007/s40290-020-00359-4
work_keys_str_mv AT penlingtonmichael plainlanguagesummariesofclinicaltrialresultsapreliminarystudytoassessavailabilityofeasytounderstandsummariesandapproachestoimprovingpublicengagement
AT silvermanharold plainlanguagesummariesofclinicaltrialresultsapreliminarystudytoassessavailabilityofeasytounderstandsummariesandapproachestoimprovingpublicengagement
AT vasudevanajithkumar plainlanguagesummariesofclinicaltrialresultsapreliminarystudytoassessavailabilityofeasytounderstandsummariesandapproachestoimprovingpublicengagement
AT pavithranpriya plainlanguagesummariesofclinicaltrialresultsapreliminarystudytoassessavailabilityofeasytounderstandsummariesandapproachestoimprovingpublicengagement