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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.

SUBMITTER: Cihoric N

PROVIDER: S-EPMC5210306 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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

Cihoric Nikola N Tsikkinis Alexandros A Minniti Giuseppe G Lagerwaard Frank J FJ Herrlinger Ulrich U Mathier Etienne E Soldatovic Ivan I Jeremic Branislav B Ghadjar Pirus P Elicin Olgun O Lössl Kristina K Aebersold Daniel M DM Belka Claus C Herrmann Evelyn E Niyazi Maximilian M

Radiation oncology (London, England) 20170103 1

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 interven ...[more]

PMID: 28049492

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Project description:BackgroundInterventional clinical trials for infectious diseases in old population have arisen much attention in recent years, however, little is known about the characteristics of registered clinical trials regarding this field. This study aimed to investigate the characteristics of registered interventional trials for infectious diseases in old populations on ClinicalTrials.gov.MethodsA cross-sectional study was performed. We used viral OR bacterial OR fungal OR parasitic OR infectious disease to search the ClinicalTrials.gov database and to assess characteristics of included trials. The age of participants was restricted to more than 65 years old. All analyses were performed using the SPSS19.0 software.ResultsA total of 138 registered trials were included. Among them, 105(76.1%) trials were completed; however, the results were available in ClinicalTrials.gov for only 44(31.9%) trials. North America was the most frequently identified study location (52.9%), followed by Europe (30.4%) and Asia (11.6%). Seventy-one percent trials focused on viral pathogens, followed by bacterial pathogens (22.5%). A total of 84.1% trials were prevention oriented. A total of 84.1% trials used randomization, 73.2% trials used parallel assignment, and 64.5% used masking. Eighty-six trials were industry-funded and 52 were non-industry-funded. Industry-funded trials had higher percentages than non-industry-funded trials in available results, prevention trial, and phase 2 and phase 3 trial, and lager sample size trial. One hundred eleven trials were vaccine trials and 27 trials were non-vaccine trials. Vaccine trials had higher percentages than non-vaccine trials in available results, leading industry sponsor and viral etiology.ConclusionsThe current study is the first study of the landscape of interventional clinical trials for infectious diseases in old populations registered in ClinicalTrials.gov, providing the basis for treatment and prevention of infectious diseases in old populations. Trials in this field are still relatively lacking, and additional and better trials are needed.

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

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

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