[Forum SIS] Seminario: Lorenzo Trippa, Adaptive trial design in glioblastoma

[Antonio Pievatolo]

Thursday 4 July 2019 at 14:30

Lorenzo Trippa, Harvard University and Dana-Farber Cancer Institute, 
Department of Statistics and Computational Biology

CNR IMATI, Via A. Corti, 12, Milano, Aula B

*Adaptive trial design in glioblastoma*

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. 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. 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. We use the results of this 
meta analysis to discuss pros and cons of trial designs in GBM. This 
analysis includes platforms and the use of external controls. Platform 
design allow to add new experimental arms to the clinical study when 
they become available, while the aim of an external controls is to 
leverage external data that were not generated from the clinical study.

-- 
Dr Antonio Pievatolo
IMATI-CNR
http://www.imati.cnr.it/joomla/index.php/people?layout=edit&id=101
ph. +39 02 23699 520

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