Cargando…

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into...

Descripción completa

Detalles Bibliográficos
Autores principales: Cihoric, Nikola, Tsikkinis, Alexandros, Minniti, Giuseppe, Lagerwaard, Frank J, Herrlinger, Ulrich, Mathier, Etienne, Soldatovic, Ivan, Jeremic, Branislav, Ghadjar, Pirus, Elicin, Olgun, Lössl, Kristina, Aebersold, Daniel M, Belka, Claus, Herrmann, Evelyn, Niyazi, Maximilian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5210306/
https://www.ncbi.nlm.nih.gov/pubmed/28049492
http://dx.doi.org/10.1186/s13014-016-0740-5
_version_ 1782490857869410304
author Cihoric, Nikola
Tsikkinis, Alexandros
Minniti, Giuseppe
Lagerwaard, Frank J
Herrlinger, Ulrich
Mathier, Etienne
Soldatovic, Ivan
Jeremic, Branislav
Ghadjar, Pirus
Elicin, Olgun
Lössl, Kristina
Aebersold, Daniel M
Belka, Claus
Herrmann, Evelyn
Niyazi, Maximilian
author_facet Cihoric, Nikola
Tsikkinis, Alexandros
Minniti, Giuseppe
Lagerwaard, Frank J
Herrlinger, Ulrich
Mathier, Etienne
Soldatovic, Ivan
Jeremic, Branislav
Ghadjar, Pirus
Elicin, Olgun
Lössl, Kristina
Aebersold, Daniel M
Belka, Claus
Herrmann, Evelyn
Niyazi, Maximilian
author_sort Cihoric, Nikola
collection PubMed
description The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13014-016-0740-5) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5210306
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-52103062017-01-06 Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov Cihoric, Nikola Tsikkinis, Alexandros Minniti, Giuseppe Lagerwaard, Frank J Herrlinger, Ulrich Mathier, Etienne Soldatovic, Ivan Jeremic, Branislav Ghadjar, Pirus Elicin, Olgun Lössl, Kristina Aebersold, Daniel M Belka, Claus Herrmann, Evelyn Niyazi, Maximilian Radiat Oncol Review The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13014-016-0740-5) contains supplementary material, which is available to authorized users. BioMed Central 2017-01-03 /pmc/articles/PMC5210306/ /pubmed/28049492 http://dx.doi.org/10.1186/s13014-016-0740-5 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review
Cihoric, Nikola
Tsikkinis, Alexandros
Minniti, Giuseppe
Lagerwaard, Frank J
Herrlinger, Ulrich
Mathier, Etienne
Soldatovic, Ivan
Jeremic, Branislav
Ghadjar, Pirus
Elicin, Olgun
Lössl, Kristina
Aebersold, Daniel M
Belka, Claus
Herrmann, Evelyn
Niyazi, Maximilian
Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov
title Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov
title_full Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov
title_fullStr Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov
title_full_unstemmed Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov
title_short Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov
title_sort current status and perspectives of interventional clinical trials for glioblastoma – analysis of clinicaltrials.gov
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5210306/
https://www.ncbi.nlm.nih.gov/pubmed/28049492
http://dx.doi.org/10.1186/s13014-016-0740-5
work_keys_str_mv AT cihoricnikola currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT tsikkinisalexandros currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT minnitigiuseppe currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT lagerwaardfrankj currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT herrlingerulrich currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT mathieretienne currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT soldatovicivan currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT jeremicbranislav currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT ghadjarpirus currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT elicinolgun currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT losslkristina currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT aebersolddanielm currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT belkaclaus currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT herrmannevelyn currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov
AT niyazimaximilian currentstatusandperspectivesofinterventionalclinicaltrialsforglioblastomaanalysisofclinicaltrialsgov