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Building Data Rich Clinical Trials

Objective

Successful drug approvals on Precision Oncology (PO) using basket studies have uncovered new challenges. Research in small patient populations suffers from sustainability/ logistical issues. Platform trials are flexible solutions to test different drugs in different populations but encompass management issues that compromise flow and translational research. This is detrimental to patients/ researchers thus new technological/ methodological concepts must be urgently implemented. To overcome these limitations, Cancer Core Europe (CCE) has developed the Basket of Basket (BoB) study to provide personalized treatment to a larger number of patients by incorporating a multi-tiered molecular profiling platform, flexible modules targeting different molecular alterations and a data/ sample collection plan to enable translational research. The CCE-DART model, here proposed, is conceived to address other limitations of PO and platform trials identified by our multi-disciplinary team. With a new design, we aim to improve efficiencies and transform platform trials in data-rich translational research programs, by: (1) developing digital systems (information-technology solutions) facilitating data management and clinical-decision-making; (2) integrating accurate, dynamic imaging and molecular markers of tumor progression/ drug response; (3) using more efficient, adaptive clinical trial methodology; (4) increasing patient engagement. To achieve this, we will use harmonized data-sharing/ technological/ legal/ clinical infrastructure developed in CCE and the BoB trial that will be leveraged as a use case for testing the new model. The new concept will impact the design of new clinical trials consolidating a self-sustainable, data-rich, multi-endpoint global platform for clinical/ translational research, encompassed by a pharmacoeconomics assessment that will proof the sustainability of the model for its implementation in the Health System and as a return of the investment to society.

Field of science

  • /social sciences/other social sciences/social sciences interdisciplinary/sustainable development

Call for proposal

H2020-SC1-2020-Lump-Sum-RTD
See other projects for this call

Funding Scheme

RIA-LS - Research and Innovation action Lump Sum

Coordinator

FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON (VHIO)
Address
Calle Nazaret 115-117
08035 Barcelona
Spain
Activity type
Research Organisations
EU contribution
€ 958 114,98

Participants (10)

KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 1 077 450
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE
United Kingdom
EU contribution
€ 1 442 723,39
Address
Trinity Lane The Old Schools
CB2 1TN Cambridge
Activity type
Higher or Secondary Education Establishments
DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG
Germany
EU contribution
€ 734 842,51
Address
Im Neuenheimer Feld 280
69120 Heidelberg
Activity type
Research Organisations
STICHTING HET NEDERLANDS KANKER INSTITUUT-ANTONI VAN LEEUWENHOEK ZIEKENHUIS
Netherlands
EU contribution
€ 277 900,06
Address
Plesmanlaan 121
1066 CX Amsterdam
Activity type
Research Organisations
FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
Italy
EU contribution
€ 404 483,50
Address
Via Venezian 1
20133 Milan
Activity type
Research Organisations
INSTITUT GUSTAVE ROUSSY
France
EU contribution
€ 69 179
Address
Rue Camille Desmoulins 39
94805 Villejuif
Activity type
Research Organisations
THE UNIVERSITY OF MANCHESTER
United Kingdom
EU contribution
€ 548 295,13
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
THE HYVE BV
Netherlands
EU contribution
€ 205 725
Address
Arthur Van Schendelstraat 650
3511 MJ Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
DATARIVER SRL
Italy
EU contribution
€ 143 913,63
Address
Via Emilia Est 985 Int 2
41122 Modena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
FORMSVISION BV
Netherlands
EU contribution
€ 136 784,05
Address
Hollandse Cade 13
1391JD Abcoude
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)