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Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions

In the era of personalized medicine, the introduction of translational studies in clinical trials has substantially increased their costs, but provides the possibility of improving the productivity of trials with a better selection of recruited patients. With the overall goal of creating a roadmap t...

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Autores principales: Bagnoli, Marina, Shi, Ting Yan, Gourley, Charlie, Speiser, Paul, Reuss, Alexander, Nijman, Hans W., Creutzberg, Carien L., Scholl, Suzy, Negrouk, Anastassia, Brady, Mark F., Hasegawa, Kosei, Oda, Katsutoshi, McNeish, Iain A., Kohn, Elise C., Oza, Amit M., MacKay, Helen, Millan, David, Bennett, Katherine, Scott, Clare, Mezzanzanica, Delia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6468728/
https://www.ncbi.nlm.nih.gov/pubmed/30813545
http://dx.doi.org/10.3390/cells8030200
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author Bagnoli, Marina
Shi, Ting Yan
Gourley, Charlie
Speiser, Paul
Reuss, Alexander
Nijman, Hans W.
Creutzberg, Carien L.
Scholl, Suzy
Negrouk, Anastassia
Brady, Mark F.
Hasegawa, Kosei
Oda, Katsutoshi
McNeish, Iain A.
Kohn, Elise C.
Oza, Amit M.
MacKay, Helen
Millan, David
Bennett, Katherine
Scott, Clare
Mezzanzanica, Delia
author_facet Bagnoli, Marina
Shi, Ting Yan
Gourley, Charlie
Speiser, Paul
Reuss, Alexander
Nijman, Hans W.
Creutzberg, Carien L.
Scholl, Suzy
Negrouk, Anastassia
Brady, Mark F.
Hasegawa, Kosei
Oda, Katsutoshi
McNeish, Iain A.
Kohn, Elise C.
Oza, Amit M.
MacKay, Helen
Millan, David
Bennett, Katherine
Scott, Clare
Mezzanzanica, Delia
author_sort Bagnoli, Marina
collection PubMed
description In the era of personalized medicine, the introduction of translational studies in clinical trials has substantially increased their costs, but provides the possibility of improving the productivity of trials with a better selection of recruited patients. With the overall goal of creating a roadmap to improve translational design for future gynecological cancer trials and of defining translational goals, a main discussion was held during a brainstorming day of the Gynecologic Cancer InterGroup (GCIG) Translational Research Committee and overall conclusions are here reported. A particular emphasis was dedicated to the new frontier of the immunoprofiling of gynecological cancers. The discussion pointed out that to maximize patients’ benefit, translational studies should be integral to clinical trial design with standardization and optimization of procedures including a harmonization program of Standard Operating Procedures. Pathology-reviewed sample collection should be mandatory and ensured by dedicated funding. Biomarker validation and development should be made public and transparent to ensure rapid progresses with positive outcomes for patients. Guidelines/templates for patients’ informed consent are needed. Importantly for the public, recognized goals are to increase the involvement of advocates and to improve the reporting of translational data in a forum accessible to patients.
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spelling pubmed-64687282019-04-23 Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions Bagnoli, Marina Shi, Ting Yan Gourley, Charlie Speiser, Paul Reuss, Alexander Nijman, Hans W. Creutzberg, Carien L. Scholl, Suzy Negrouk, Anastassia Brady, Mark F. Hasegawa, Kosei Oda, Katsutoshi McNeish, Iain A. Kohn, Elise C. Oza, Amit M. MacKay, Helen Millan, David Bennett, Katherine Scott, Clare Mezzanzanica, Delia Cells Perspective In the era of personalized medicine, the introduction of translational studies in clinical trials has substantially increased their costs, but provides the possibility of improving the productivity of trials with a better selection of recruited patients. With the overall goal of creating a roadmap to improve translational design for future gynecological cancer trials and of defining translational goals, a main discussion was held during a brainstorming day of the Gynecologic Cancer InterGroup (GCIG) Translational Research Committee and overall conclusions are here reported. A particular emphasis was dedicated to the new frontier of the immunoprofiling of gynecological cancers. The discussion pointed out that to maximize patients’ benefit, translational studies should be integral to clinical trial design with standardization and optimization of procedures including a harmonization program of Standard Operating Procedures. Pathology-reviewed sample collection should be mandatory and ensured by dedicated funding. Biomarker validation and development should be made public and transparent to ensure rapid progresses with positive outcomes for patients. Guidelines/templates for patients’ informed consent are needed. Importantly for the public, recognized goals are to increase the involvement of advocates and to improve the reporting of translational data in a forum accessible to patients. MDPI 2019-02-26 /pmc/articles/PMC6468728/ /pubmed/30813545 http://dx.doi.org/10.3390/cells8030200 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Perspective
Bagnoli, Marina
Shi, Ting Yan
Gourley, Charlie
Speiser, Paul
Reuss, Alexander
Nijman, Hans W.
Creutzberg, Carien L.
Scholl, Suzy
Negrouk, Anastassia
Brady, Mark F.
Hasegawa, Kosei
Oda, Katsutoshi
McNeish, Iain A.
Kohn, Elise C.
Oza, Amit M.
MacKay, Helen
Millan, David
Bennett, Katherine
Scott, Clare
Mezzanzanica, Delia
Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions
title Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions
title_full Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions
title_fullStr Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions
title_full_unstemmed Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions
title_short Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions
title_sort gynecological cancers translational, research implementation, and harmonization: gynecologic cancer intergroup consensus and still open questions
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6468728/
https://www.ncbi.nlm.nih.gov/pubmed/30813545
http://dx.doi.org/10.3390/cells8030200
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