Leveraging external data in the design and analysis of clinical trials in neuro-oncology

R Rahman, S Ventz, J McDunn, B Louv… - The Lancet …, 2021 - thelancet.com
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 …

The use of external control data for predictions and futility interim analyses in clinical trials

S Ventz, L Comment, B Louv, R Rahman… - Neuro …, 2022 - academic.oup.com
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 …

Design and evaluation of an external control arm using prior clinical trials and real-world data

S Ventz, A Lai, TF Cloughesy, PY Wen, L Trippa… - Clinical Cancer …, 2019 - AACR
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 …

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 …

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 …

[HTML][HTML] Evaluating eligibility criteria of oncology trials using real-world data and AI

R Liu, S Rizzo, S Whipple, N Pal, AL Pineda, M Lu… - Nature, 2021 - nature.com
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 …

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 …

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 …

[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 …

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 …