Leveraging external data in the design and analysis of clinical trials in neuro-oncology
Integration of external control data, with patient-level information, in clinical trials has the
potential to accelerate the development of new treatments in neuro-oncology by …
potential to accelerate the development of new treatments in neuro-oncology by …
The use of external control data for predictions and futility interim analyses in clinical trials
Background External control (EC) data from completed clinical trials and electronic health
records can be valuable for the design and analysis of future clinical trials. We discuss the …
records can be valuable for the design and analysis of future clinical trials. We discuss the …
Design and evaluation of an external control arm using prior clinical trials and real-world data
Purpose: We discuss designs and interpretable metrics of bias and statistical efficiency of
“externally controlled” trials (ECT) and compare ECT performance to randomized and single …
“externally controlled” trials (ECT) and compare ECT performance to randomized and single …
Phase 0 and window of opportunity clinical trial design in neuro-oncology: a RANO review
MA Vogelbaum, D Krivosheya… - Neuro …, 2020 - academic.oup.com
Glioblastoma is a devastating disease with poor prognosis. Few effective chemotherapeutics
are currently available, and much effort has been expended to identify new drugs capable of …
are currently available, and much effort has been expended to identify new drugs capable of …
Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients
EQ Lee, M Weller, J Sul, SJ Bagley… - Neuro …, 2020 - academic.oup.com
Building on an initiative to enhance clinical trial participation involving the Society for Neuro-
Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy …
Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy …
[HTML][HTML] Evaluating eligibility criteria of oncology trials using real-world data and AI
There is a growing focus on making clinical trials more inclusive but the design of trial
eligibility criteria remains challenging,–. Here we systematically evaluate the effect of …
eligibility criteria remains challenging,–. Here we systematically evaluate the effect of …
The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?
AM Vanderbeek, R Rahman, G Fell, S Ventz… - Neuro …, 2018 - academic.oup.com
Background There have been few treatment advances for patients with glioblastoma (GBM)
despite increasing scientific understanding of the disease. While factors such as intrinsic …
despite increasing scientific understanding of the disease. While factors such as intrinsic …
Glioblastoma clinical trials: current landscape and opportunities for improvement
SJ Bagley, S Kothari, R Rahman, EQ Lee… - Clinical Cancer …, 2022 - AACR
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 …
of the multitude of recent phase III trials that have failed to meet their primary endpoints …
[HTML][HTML] Application of real-world data to external control groups in oncology clinical trial drug development
TA Yap, I Jacobs, E Baumfeld Andre, LJ Lee… - Frontiers in …, 2022 - frontiersin.org
Randomized controlled trials (RCTs) that assess overall survival are considered the “gold
standard” when evaluating the efficacy and safety of a new oncology intervention. However …
standard” when evaluating the efficacy and safety of a new oncology intervention. However …
Individualized screening trial of innovative glioblastoma therapy (INSIGhT): a Bayesian adaptive platform trial to develop precision medicines for patients with …
BM Alexander, L Trippa, S Gaffey… - JCO Precision …, 2019 - ascopubs.org
PURPOSE Adequately prioritizing the numerous therapies and biomarkers available in late-
stage testing for patients with glioblastoma (GBM) requires an efficient clinical testing …
stage testing for patients with glioblastoma (GBM) requires an efficient clinical testing …