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Meta-Analysis
. 2018 Jul 5;20(8):1034-1043.
doi: 10.1093/neuonc/noy027.

The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?

Alyssa M Vanderbeek  1   2 , Rifaquat Rahman  1   2 , Geoffrey Fell  3   4   2 , Steffen Ventz  2   5 , Tianqi Chen  3   4   2 , Robert Redd  3   4   2 , Giovanni Parmigiani  3   4   2 , Timothy F Cloughesy  6 , Patrick Y Wen  7 , Lorenzo Trippa  3   4   2 , Brian M Alexander  1   7   2
Affiliations
Meta-Analysis

The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?

Alyssa M Vanderbeek et al. Neuro Oncol. .

Abstract

Background: There have been few treatment advances for patients with glioblastoma (GBM) despite increasing scientific understanding of the disease. While factors such as intrinsic tumor biology and drug delivery are challenges to developing efficacious therapies, it is unclear whether the current clinical trial landscape is optimally evaluating new therapies and biomarkers.

Methods: We queried ClinicalTrials.gov for interventional clinical trials for patients with GBM initiated between January 2005 and December 2016 and abstracted data regarding phase, status, start and end dates, testing locations, endpoints, experimental interventions, sample size, clinical presentation/indication, and design to better understand the clinical trials landscape.

Results: Only approximately 8%-11% of patients with newly diagnosed GBM enroll on clinical trials with a similar estimate for all patients with GBM. Trial duration was similar across phases with median time to completion between 3 and 4 years. While 93% of clinical trials were in phases I-II, 26% of the overall clinical trial patient population was enrolled on phase III studies. Of the 8 completed phase III trials, only 1 reported positive results. Although 58% of the phase III trials were supported by phase II data with a similar endpoint, only 25% of these phase II trials were randomized.

Conclusions: The clinical trials landscape for GBM is characterized by long development times, inadequate dissemination of information, suboptimal go/no-go decision making, and low patient participation.

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Figures

Fig. 1
Fig. 1
Therapeutic clinical trial identification and selection.
Fig. 2
Fig. 2
Distribution of trials (A) and patients (B) among phases.
Fig. 3
Fig. 3
Cumulative incidence of linked publications for primary clinical trial results.
See this image and copyright information in PMC

Comment in

References

    1. Alexander B, Cloughesy T. Adult glioblastoma. J Clin Oncol. 2017;35(21):2402–2409. - PubMed
    1. Sachs M. An Interface to the Clinicaltrials.Gov API. 2017. https://github.com/sachsmc/rclinicaltrials.
    1. Cihoric N, Tsikkinis A, Minniti G. Current status and perspectives of interventional clinical trials for glioblastoma—analysis of ClinicalTrials.gov. Radiat Oncol. 2017;12(1). doi:10.1186/s13014-016-0740-5. - PMC - PubMed
    1. 110th Congress. Food and Drug Administration Amendments Act of 2007 2007. https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm.
    1. Home—ClinicalTrials.gov https://www.clinicaltrials.gov/. Accessed October 31, 2017.

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