DISP-10. The global landscape of glioblastoma clinical trials: A missing map for low- and middle-income countries

Abstract BACKGROUND Glioblastoma is the most common primary CNS malignancy in adults with a median life expectancy of 11-12 months. Limited progress in treatment options and a poor prognosis have made glioblastoma a major focus in clinical trials. This study analyses the current clinical trial landscape and evaluates access to investigational treatments in low- and middle-income countries (LMICs). METHODS A comprehensive analysis was conducted using the ClinicalTrials.gov database, including all interventional trials on glioblastoma alone or with other solid tumors initiated since January 1, 2015. Trial phase, status, allocation, and site locations were extracted and analyzed using descriptive statistics. RESULTS As of the data cut-off on May 1, 2025, a total of 884 interventional clinical trials were identified. Among these, 55 trials were categorized as preclinical, 625 were early-phase studies, and only 54 were Phase 3 or 4 trials. At the time of analysis, 54.6% of the trials were stated as active, while 34.05% had either been completed or terminated. The primary objective in 88.24% of the studies was treatment, with the remainder focused on other interventions. Importantly, only 195 trials employed randomization. An analysis of trial site distribution revealed that only 192 clinical trials had sites located outside the U.S., Canada, Europe, and Australia and just 132 trials involved sites in LMICs. Among these, 113 trials were developed and conducted locally within a single LMIC, while only 19 were multicenter studies led by high-income countries. Importantly, when upper-middle-income countries were excluded, only 7 trials included sites in low- and lower-middle-income countries. CONCLUSIONS Despite the large number of clinical trials conducted globally, LMICs remain significantly underrepresented. This highlights a major global health issue, as patients diagnosed with glioblastoma in LMICs are often deprived from the access to investigational therapies. Urgent actions are required to expand clinical trial access in LMICs.

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Journal
Neuro-Oncology
Published
2025-11-01
DOI
https://doi.org/10.1093/neuonc/noaf201.0771
Primary Topic
Ethics in Clinical Research
Type
article
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article

DISP-10. The global landscape of glioblastoma clinical trials: A missing map for low- and middle-income countries

Armine Lazaryan, Saten Hovhannisyan, Lusine Mkrtchyan, Gevorg Tamamyan et al.
Neuro-Oncology
Ethics in Clinical Research
article

DISP-10. The global landscape of glioblastoma clinical trials: A missing map for low- and middle-income countries

Armine Lazaryan, Saten Hovhannisyan, Lusine Mkrtchyan, Gevorg Tamamyan, Ruzanna Papyan, Samvel Bardakhchyan, Ibrahim A. Qaddoumi, Amalya Sargsyan, Eduard Asatryan, Julieta Hoveyan, Elen Baloyan, Niko Arzumanyan, Ina Khachatryan, Harutyun Papoyan, Karen Bediryan, Mane Ghevondyan, Tatev Ghazaryan, Lusine Avagyan, Paylak Sujyan
article en

Abstract

Abstract BACKGROUND Glioblastoma is the most common primary CNS malignancy in adults with a median life expectancy of 11-12 months. Limited progress in treatment options and a poor prognosis have made glioblastoma a major focus in clinical trials. This study analyses the current clinical trial landscape and evaluates access to investigational treatments in low- and middle-income countries (LMICs). METHODS A comprehensive analysis was conducted using the ClinicalTrials.gov database, including all interventional trials on glioblastoma alone or with other solid tumors initiated since January 1, 2015. Trial phase, status, allocation, and site locations were extracted and analyzed using descriptive statistics. RESULTS As of the data cut-off on May 1, 2025, a total of 884 interventional clinical trials were identified. Among these, 55 trials were categorized as preclinical, 625 were early-phase studies, and only 54 were Phase 3 or 4 trials. At the time of analysis, 54.6% of the trials were stated as active, while 34.05% had either been completed or terminated. The primary objective in 88.24% of the studies was treatment, with the remainder focused on other interventions. Importantly, only 195 trials employed randomization. An analysis of trial site distribution revealed that only 192 clinical trials had sites located outside the U.S., Canada, Europe, and Australia and just 132 trials involved sites in LMICs. Among these, 113 trials were developed and conducted locally within a single LMIC, while only 19 were multicenter studies led by high-income countries. Importantly, when upper-middle-income countries were excluded, only 7 trials included sites in low- and lower-middle-income countries. CONCLUSIONS Despite the large number of clinical trials conducted globally, LMICs remain significantly underrepresented. This highlights a major global health issue, as patients diagnosed with glioblastoma in LMICs are often deprived from the access to investigational therapies. Urgent actions are required to expand clinical trial access in LMICs.

Neuro-OncologyVol. 27(Supplement_5)
St. Jude Children's Research Hospital (US), Yerevan State University (AM), Women's and Children's Hospital (AU), Scientific Center of Zoology and Hydroecology (AM), CS Diagnostics (DE), Arabkir Joint Medical Center (AM), Yerevan State Medical University (AM), National Academy of Sciences of Armenia (AM)
Openalex Percentile: Top 56%
Ethics in Clinical Research
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