title: Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.
abstract: 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.
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland. nikola.cihoric@gmail.com.
authors.forename: Nikola
authors.identifier: http://orcid.org/0000-0003-1534-8520
authors.initials: N
authors.lastname: Cihoric
authors.affiliation: Department of Genitourinary Oncology, David H. Koch Center for Applied Research of Genitourinary Cancers, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Alexandros
authors.initials: A
authors.lastname: Tsikkinis
authors.affiliation: Unit of Radiation Oncology, Sant' Andrea Hospital, University Sapienza, and IRCCS Neuromed, Pozzilli (IS), Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Minniti
authors.affiliation: Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Lagerwaard
authors.affiliation: Department of Neurology, Division of Clinical Neurooncology, University of Bonn Medical Center, Bonn, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Herrlinger
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.
authors.forename: Etienne
authors.initials: E
authors.lastname: Mathier
authors.affiliation: Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Ivan
authors.initials: I
authors.lastname: Soldatovic
authors.affiliation: Institute of Lung Diseases, Sremska Kamenica, Serbia and BioIRC Center for Biomedical Research, Kragujevac, Serbia.
authors.forename: Branislav
authors.initials: B
authors.lastname: Jeremic
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Pirus
authors.initials: P
authors.lastname: Ghadjar
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.
authors.forename: Olgun
authors.initials: O
authors.lastname: Elicin
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.
authors.forename: Kristina
authors.initials: K
authors.lastname: Lössl
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Aebersold
authors.affiliation: Department of Radiation Oncology, LMU Munich, München, Germany.|German Cancer Consortium (DKTK) & German Cancer Research Center (DKFZ), Heidelberg, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Belka
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Herrmann
authors.affiliation: Department of Radiation Oncology, LMU Munich, München, Germany.|German Cancer Consortium (DKTK) & German Cancer Research Center (DKFZ), Heidelberg, Germany.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Niyazi
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D005909:Glioblastoma / Q000628:therapy*; D006801:Humans; D012107:Research Design
keywords: Clinicaltrials.gov; Glioblastoma; Interventional Clinical Trials