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Impact of data transparency: Scientific publications

Data transparency has been an important aspect of medical research as it helps in enabling evidence-based decisions in medicine which leads to foster trust among the patients and research community alike. Currently, it is one of the key talking points owing to a number of initiatives taken by the ph...

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Detalles Bibliográficos
Autores principales: Joshi, Mohit, Bhardwaj, Payal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5799949/
https://www.ncbi.nlm.nih.gov/pubmed/29430415
http://dx.doi.org/10.4103/picr.PICR_104_17
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author Joshi, Mohit
Bhardwaj, Payal
author_facet Joshi, Mohit
Bhardwaj, Payal
author_sort Joshi, Mohit
collection PubMed
description Data transparency has been an important aspect of medical research as it helps in enabling evidence-based decisions in medicine which leads to foster trust among the patients and research community alike. Currently, it is one of the key talking points owing to a number of initiatives taken by the pharmaceutical organizations, regulatory bodies, and the other decision enablers of the industry. Thanks to this, there are a number of ways by which a single piece of datum is available through multiple access points, namely, clinical trial disclosures (CTDs), clinical study reports (CSRs), plain language summaries, and scientific publications including abstracts, posters, and manuscripts, to name a few. This may pose a burden of documentation on the pharmaceutical organizations, demanding downsizing of medical writing documents. Since CTDs, CSRs, and other regulatory document are more or less template driven; there may not be much scope to interfere with their structure and submission timings. Scientific publications, on the other hand, provide the flexibility of presenting the clinical data that is typically not dependent on a particular format and timelines. The present paper discusses how the upcoming data transparency initiatives could affect the publication practices across the pharmaceutical industry and what could pharmaceutical companies do to get the maximum benefit out of the data transparency initiatives.
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spelling pubmed-57999492018-02-09 Impact of data transparency: Scientific publications Joshi, Mohit Bhardwaj, Payal Perspect Clin Res Review Article Data transparency has been an important aspect of medical research as it helps in enabling evidence-based decisions in medicine which leads to foster trust among the patients and research community alike. Currently, it is one of the key talking points owing to a number of initiatives taken by the pharmaceutical organizations, regulatory bodies, and the other decision enablers of the industry. Thanks to this, there are a number of ways by which a single piece of datum is available through multiple access points, namely, clinical trial disclosures (CTDs), clinical study reports (CSRs), plain language summaries, and scientific publications including abstracts, posters, and manuscripts, to name a few. This may pose a burden of documentation on the pharmaceutical organizations, demanding downsizing of medical writing documents. Since CTDs, CSRs, and other regulatory document are more or less template driven; there may not be much scope to interfere with their structure and submission timings. Scientific publications, on the other hand, provide the flexibility of presenting the clinical data that is typically not dependent on a particular format and timelines. The present paper discusses how the upcoming data transparency initiatives could affect the publication practices across the pharmaceutical industry and what could pharmaceutical companies do to get the maximum benefit out of the data transparency initiatives. Medknow Publications & Media Pvt Ltd 2018 /pmc/articles/PMC5799949/ /pubmed/29430415 http://dx.doi.org/10.4103/picr.PICR_104_17 Text en Copyright: © 2018 Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Review Article
Joshi, Mohit
Bhardwaj, Payal
Impact of data transparency: Scientific publications
title Impact of data transparency: Scientific publications
title_full Impact of data transparency: Scientific publications
title_fullStr Impact of data transparency: Scientific publications
title_full_unstemmed Impact of data transparency: Scientific publications
title_short Impact of data transparency: Scientific publications
title_sort impact of data transparency: scientific publications
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5799949/
https://www.ncbi.nlm.nih.gov/pubmed/29430415
http://dx.doi.org/10.4103/picr.PICR_104_17
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