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Published on: October 27, 2014
Glioblastoma Clinical Trials: Current Landscape and Opportunities for Improvement
Stephen J Bagley1, Shawn Kothari1, Rifaquat Rahman2
1Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Abstract:
Therapeutic advances for glioblastoma have been minimal over the past 2 decades. In light of the multitude of recent phase III trials that have failed to meet their primary endpoints following promising preclinical and early-phase programs, a Society for Neuro-Oncology Think Tank was held in November 2020 to prioritize areas for improvement in the conduct of glioblastoma clinical trials. Here, we review the literature, identify challenges related to clinical trial eligibility criteria and trial design in glioblastoma, and provide recommendations from the Think Tank. In addition, we provide a data-driven context with which to frame this discussion by analyzing key study design features of adult glioblastoma clinical trials listed on ClinicalTrials.gov as "recruiting" or "not yet recruiting" as of February 2021.
Insights
Glioblastoma (GBM) clinical trials face significant challenges, hindering therapeutic progress. A Society for Neuro-Oncology Think Tank identified key issues in trial design and eligibility criteria to improve future GBM research.
Area of Science:
- Neuro-Oncology
- Clinical Trial Design
- Glioblastoma Therapeutics
Background:
- Therapeutic advances for glioblastoma (GBM) have been stagnant for two decades.
- Numerous Phase III glioblastoma trials have failed despite promising early-phase results.
- This highlights critical issues in current clinical trial methodologies.
Purpose of the Study:
- To review literature and identify challenges in glioblastoma clinical trial conduct.
- To provide recommendations for improving glioblastoma clinical trial design and eligibility criteria.
- To analyze current glioblastoma clinical trial designs for data-driven insights.
Main Methods:
- Literature review on glioblastoma clinical trials.
- Analysis of clinical trial design features from ClinicalTrials.gov (recruiting/not yet recruiting as of Feb 2021).
- Expert consensus from a Society for Neuro-Oncology Think Tank meeting.
Main Results:
- Identified significant challenges in glioblastoma trial eligibility criteria.
- Highlighted limitations in current glioblastoma clinical trial designs.
- Provided a data-driven overview of ongoing adult glioblastoma trials.
Conclusions:
- Recommendations are proposed to enhance the rigor and success rate of future glioblastoma clinical trials.
- Addressing trial design and eligibility criteria is crucial for advancing GBM therapies.
- Improved trial conduct is essential to overcome therapeutic stagnation in glioblastoma.
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