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Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges

The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing...

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Autores principales: Rutella, Sergio, Cannarile, Michael A, Gnjatic, Sacha, Gomes, Bruno, Guinney, Justin, Karanikas, Vaios, Karkada, Mohan, Kirkwood, John M, Kotlan, Beatrix, Masucci, Giuseppe V, Meeusen, Els, Monette, Anne, Naing, Aung, Thorsson, Vésteinn, Tschernia, Nicholas, Wang, Ena, Wells, Daniel K, Wyant, Timothy L, Cesano, Alessandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604864/
https://www.ncbi.nlm.nih.gov/pubmed/33127656
http://dx.doi.org/10.1136/jitc-2020-001389
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author Rutella, Sergio
Cannarile, Michael A
Gnjatic, Sacha
Gomes, Bruno
Guinney, Justin
Karanikas, Vaios
Karkada, Mohan
Kirkwood, John M
Kotlan, Beatrix
Masucci, Giuseppe V
Meeusen, Els
Monette, Anne
Naing, Aung
Thorsson, Vésteinn
Tschernia, Nicholas
Wang, Ena
Wells, Daniel K
Wyant, Timothy L
Cesano, Alessandra
author_facet Rutella, Sergio
Cannarile, Michael A
Gnjatic, Sacha
Gomes, Bruno
Guinney, Justin
Karanikas, Vaios
Karkada, Mohan
Kirkwood, John M
Kotlan, Beatrix
Masucci, Giuseppe V
Meeusen, Els
Monette, Anne
Naing, Aung
Thorsson, Vésteinn
Tschernia, Nicholas
Wang, Ena
Wells, Daniel K
Wyant, Timothy L
Cesano, Alessandra
author_sort Rutella, Sergio
collection PubMed
description The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societies. Each of these stakeholder groups has differing interests in the use and sharing of clinical trial and biomarker data, and the conflicts caused by these differing interests represent significant obstacles to effective, widespread sharing of data. Thus, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to identify the current barriers to biomarker data sharing in immuno-oncology (IO) and to help in establishing professional standards for the responsible sharing of clinical trial data. The conclusions of the committee are described in two position papers: Volume I—conceptual challenges and Volume II—practical challenges, the first of which is presented in this manuscript. Additionally, the committee suggests actions by key stakeholders in the field (including organizations and professional societies) as the best path forward, encouraging the cultural shift needed to ensure responsible data sharing in the IO research setting.
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spelling pubmed-76048642020-11-12 Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges Rutella, Sergio Cannarile, Michael A Gnjatic, Sacha Gomes, Bruno Guinney, Justin Karanikas, Vaios Karkada, Mohan Kirkwood, John M Kotlan, Beatrix Masucci, Giuseppe V Meeusen, Els Monette, Anne Naing, Aung Thorsson, Vésteinn Tschernia, Nicholas Wang, Ena Wells, Daniel K Wyant, Timothy L Cesano, Alessandra J Immunother Cancer Position Article and Guidelines The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societies. Each of these stakeholder groups has differing interests in the use and sharing of clinical trial and biomarker data, and the conflicts caused by these differing interests represent significant obstacles to effective, widespread sharing of data. Thus, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to identify the current barriers to biomarker data sharing in immuno-oncology (IO) and to help in establishing professional standards for the responsible sharing of clinical trial data. The conclusions of the committee are described in two position papers: Volume I—conceptual challenges and Volume II—practical challenges, the first of which is presented in this manuscript. Additionally, the committee suggests actions by key stakeholders in the field (including organizations and professional societies) as the best path forward, encouraging the cultural shift needed to ensure responsible data sharing in the IO research setting. BMJ Publishing Group 2020-10-30 /pmc/articles/PMC7604864/ /pubmed/33127656 http://dx.doi.org/10.1136/jitc-2020-001389 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Position Article and Guidelines
Rutella, Sergio
Cannarile, Michael A
Gnjatic, Sacha
Gomes, Bruno
Guinney, Justin
Karanikas, Vaios
Karkada, Mohan
Kirkwood, John M
Kotlan, Beatrix
Masucci, Giuseppe V
Meeusen, Els
Monette, Anne
Naing, Aung
Thorsson, Vésteinn
Tschernia, Nicholas
Wang, Ena
Wells, Daniel K
Wyant, Timothy L
Cesano, Alessandra
Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges
title Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges
title_full Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges
title_fullStr Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges
title_full_unstemmed Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges
title_short Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges
title_sort society for immunotherapy of cancer clinical and biomarkers data sharing resource document: volume i—conceptual challenges
topic Position Article and Guidelines
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604864/
https://www.ncbi.nlm.nih.gov/pubmed/33127656
http://dx.doi.org/10.1136/jitc-2020-001389
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