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Spearheading next generation clinical trials: Cancer Core Europe's design and development of data rich, dynamic studies in oncology
- Incorporating experts from the seven European comprehensive cancer centers belonging to the Cancer Core Europe (CCE) Consortium, along with an additional four non-CCE partners*, the EU-funded, multi-site project CCE Building Data Rich Clinical Trials (CCE-DART), has now launched.
- Coordinated by VHIO's Elena Garralda, CCE-DART seeks to become a groundbreaking example in driving a novel generation of clinical trials in the current era of precision oncology.
- This pioneering project will develop interconnected tools to reduce the current complexity of investigator-initiated trials and better guide clinical decision-making by incorporating cutting-edge digital technologies and platforms.
In the current era of precision medicine, the advent of novel, adaptive clinical studies including the so-called basket and umbrella clinical trials, among others, aim to address the current challenges in oncology including the globalization of clinical research, and the use and implementation of emerging health technologies.
While randomized controlled trials are considered the gold standard for studying the effectiveness of treatment approaches and anti-cancer therapies, they do not allow for the 'real time' and necessary adaptation in tune with the rapid pace of cancer discovery - especially in the academic setting.
To overcome this challenge, novel clinical trial designs promote the optimization of biomarker-drug co-development towards more precisely tailoring therapies to each disease setting, each individual patient. In short, these 'smarter' contenders seek to more effectively identify the optimal treatment for the right patient, at the right time, and promise to overcome the rigidity and limitations of traditional clinical trials.
The newly launched, EU-funded Cancer Core Europe Consortium-Building Data Rich Clinical Trials (CCE-DART) project is coordinated by VHIO's Elena Garralda, Director of VHIO's Research Unit for Molecular Therapy of Cancer (UITM) - "la Caixa" Foundation, and Principal Investigator of our Early Clinical Drug Development Group, and carried out in collaboration with other leading experts from within Cancer Core Europe Consortium*.
By harnessing and incorporating powerful cutting-edge technologies, methods and platforms, CCE-DART investigators will spur the design, development, and ringing in of a new generation of data rich, dynamic studies in oncology.
Building on the CCE-developed Basket of Baskets (BoB) investigator-initiated and adaptive trial which launched in 2018, CCE-DART will further enhance BoB's harmonized, molecular multi-tier profiling platform to more precisely match patients to novel anti-cancer medicines based on the genetic specificities of their individual tumors. In parallel, the researchers will continue to develop multiple treatments in genomically-selected populations.
By introducing new tools -or adapting existing ones- the project will also seek to elevate the management and decision-making of clinical studies to the digital age, and ultimately represent a groundbreaking example for driving a new generation of clinical trials in by leveraging novel technologies within existing clinical structures.
"The wealth of expertise, cutting edge technologies, and clinical trial capabilities provided through CCE's member centers and sites, along with our additional four partners, the Digital Experimental Cancer Medicine Team, The Hyve, DataRiver, and Form Vision, will enable us to fortify and further develop the BoB trial's dynamic and highly adaptive design," said Elena Garralda, Coordinator of the recently launched CCE-DART initiative.
"We will collectively seek to incorporate newer, more effective methods to the design, development and analysis of a new generation of data rich clinical trials, with particular emphasis on creating a sustainable framework for academic-led initiatives. As importantly, we are also dedicated to promoting and fostering the involvement of the cancer patient community in the design and implementation of our studies," added Alejandro Piris, Head of VHIO's Scientific Coordination Area at VHIO, who is coordinating the management and oversight of this present project.
Common infrastructures and the wealth of experience gained through CCE sites' running of innovative academic studies, including the BoB study, will undoubtedly help the project partners to deliver on the four key objectives. Namely, to improve patient enrolment strategies and trial designs, accelerate the use of novel health technologies in the clinical setting, optimize clinical trial data management and analysis, and globalize the results of the project by promoting transparency of investigator-initiated studies.
"Supported by EU's Horizon 2020 Framework Programme, CCE-DART will aim to elevate current networks and existing legal, technological and clinical infrastructures to further develop a new generation of methods and tools for more efficient, personalized, and effective clinical trials in oncology," concluded Elena Garralda.
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For more information about VHIO's involvement in CCE-DART, please contact Amanda Wren, Head of the Director's Office and Global Communications, Vall d´Hebron Institute of Oncology (VHIO): awren@vhio.net, Tel. +34 695207886.
* CCE Building Data Rich Clinical Trials (CCE-DART) Participants.
Cancer Core Europe (CCE) Consortium Members:
Non-CCE Members:
This project has received funding from the European Union's Horizon 2020 framework programme research under grant agreement No: 965397