TY - JOUR
T1 - ERANET JTC 2011
T2 - Submission and Activation of an International Academic Translational Project in Advanced Breast Cancer. Experience From the ET-FES Study
AU - Monti, Manuela
AU - Degenhardt, Tom
AU - Brain, Etienne
AU - Wuerstlein, Rachel
AU - Argusti, Alessandra
AU - Puntoni, Matteo
AU - Rollandi, Gian Andrea
AU - Corradengo, Davide
AU - Boni, Luca
AU - Ilhan, Harun
AU - Nanni, Oriana
AU - Cortes, Javier
AU - Piris-Gimenez, Alejandro
AU - Piccardo, Arnoldo
AU - Iacozzi, Massimiliano
AU - Matteucci, Federica
AU - Di Iorio, Valentina
AU - Alberini, Jean Louis
AU - Schröder, Carolien
AU - Harbeck, Nadia
AU - Gennari, Alessandra
N1 - Funding Information:
Trials to improve the knowledge on personalized therapy strategies are usually developed on large-scale populations. Therefore, funding is a difficult issue, as the unmet medical needs to better understand who is really benefiting from a drug with a broad indication, does not necessarily arouse the interest of the industry (1). As a consequence, there is an unmet medical need that could be addressed by independent academic research in particular multi-institutional, international translational research. It is of great interest to strengthen translational cancer research with the integration of basic, epidemiological, preclinical, and clinical research with the implementation and evaluation of interventions in prevention, diagnosis, prognosis, treatment, and care. Oncological clinical research community encounters many hurdles in setting up multicentre trials, particularly for Investigator-driven academic trial. The main issues concern the administrative complexity and heterogeneous clinical staff training and infrastructure support that often limit the opportunity to participate into international clinical trials. Efficient planning and performance of clinical research rely on the interplay among teams of different clinicians and other components such as ethical committees, national and local authorities, promoter and drug manufactories, patient association, as well as hospital administration. Joining forces within multinational project applications and more interdisciplinary projects will be necessary to realize the full potential of the increasing number of developments for theragnostic applications. The scope of a network organization at a national level is to facilitate the effective use of molecular imaging in clinical trials through standardization, coordination, and education for drug development and regulatory approval. The Italian network model could be transferred to an European level to facilitate the participation of all network centers into Investigator-driven non-academic International multicentre clinical trials. Molecular imaging with PET is a rapidly emerging technique. In breast cancer patients, more than 45 different PET tracers have been or are presently being tested. But regretfully so far, only [18F]-FDG PET has been incorporated into breast cancer guidelines. PET tracers will likely allow better breast cancer patient selection for the right treatment. However, for proof of the clinical relevance of the tracers, especially for analysis in a multicenter setting, standardization of the technology and access to the novel PET tracer are required. Funding for such an approach has largely been lacking. The ERA-NET TRANSCAN call aims at combining translational cancer research funding programs in 19 Member States and Associated Countries. TRANSCAN will concentrate translational research resources and will provide relevant financial support to address large scale problems that will be relevant for the improvement of translational cancer research in every Member State and possibly overall in Europe. TRANSCAN will identify opportunities for coordinated translational research, and will thus contribute to the development of a coordinated funding research policy shared by European countries. The activation of an international, non-profit clinical trial supported by the ERA-NET (Aligning national/regional translational cancer research programmes and activities) and funded by the European Commission requires specific timelines according to the EU rules. This paper describes the complexity of activating an international study within the ET-FES TRANSCAN project in 4 EU countries (France, Germany, Italy, and Spain).
Publisher Copyright:
Copyright © 2022 Monti, Degenhardt, Brain, Wuerstlein, Argusti, Puntoni, Rollandi, Corradengo, Boni, Ilhan, Nanni, Cortes, Piris-Gimenez, Piccardo, Iacozzi, Matteucci, Di Iorio, Alberini, Schröder, Harbeck and Gennari.
PY - 2022/1/13
Y1 - 2022/1/13
N2 - Background: Academic research is important to face unmet medical needs. The Oncological community encounters many hurdles in setting up multicenter investigator-driven trials mainly due to administrative complexity. The purpose of a network organization at a multinational level is to facilitate clinical trials through standardization, coordination, and education for drug development and regulatory approval.Methods: The application of an European grant foresees the creation of a consortium which aims at facilitating multi-center academic clinical trials. Results: The ERA-NET TRANSCAN Call 2011 on “Validation of biomarkers for personalized cancer medicine” was released on December 2011. This project included Italian, Spanish, French and German centers. The approval process included Consortium constitution, project submission, Clinical Trial Submission, and activation on a national level. The different timescales for submitting study documents in each Country and the misalignment of objections by each Competent Authority CA, generated several requests for changes to the study documents which meant amendments had to be made; as requested by the 2001/20/EC Directive, the alignment of core documents is mandatory. This procedure impacted significantly on study activation timelines. Time to first patient in was 14, 10, 28, and 31 months from the date of submission in Italy, France, Spain, and Germany, respectively. Accrual was stopped on 22nd January 2021 due to an 18F FES shortage as the primary reason but also for having exceeded the project deadlines with consequent exhaustion of the funds allocated for the project.Conclusions: Pharmaceutical companies might be reluctant to fund research projects aimed at treatment individualization if the approval for a wider indication has already been achieved. Academic trials therefore become fundamental for promoting trials which are not attractive to big pharma. It was very difficult and time consuming to activate an academic clinical trial, for this reason, a study may become “old” as new drugs entered into the market. National institutions should promote the development of clinical research infrastructures and network with competence in regulatory, ethical, and legal skills to speed up academic research.
AB - Background: Academic research is important to face unmet medical needs. The Oncological community encounters many hurdles in setting up multicenter investigator-driven trials mainly due to administrative complexity. The purpose of a network organization at a multinational level is to facilitate clinical trials through standardization, coordination, and education for drug development and regulatory approval.Methods: The application of an European grant foresees the creation of a consortium which aims at facilitating multi-center academic clinical trials. Results: The ERA-NET TRANSCAN Call 2011 on “Validation of biomarkers for personalized cancer medicine” was released on December 2011. This project included Italian, Spanish, French and German centers. The approval process included Consortium constitution, project submission, Clinical Trial Submission, and activation on a national level. The different timescales for submitting study documents in each Country and the misalignment of objections by each Competent Authority CA, generated several requests for changes to the study documents which meant amendments had to be made; as requested by the 2001/20/EC Directive, the alignment of core documents is mandatory. This procedure impacted significantly on study activation timelines. Time to first patient in was 14, 10, 28, and 31 months from the date of submission in Italy, France, Spain, and Germany, respectively. Accrual was stopped on 22nd January 2021 due to an 18F FES shortage as the primary reason but also for having exceeded the project deadlines with consequent exhaustion of the funds allocated for the project.Conclusions: Pharmaceutical companies might be reluctant to fund research projects aimed at treatment individualization if the approval for a wider indication has already been achieved. Academic trials therefore become fundamental for promoting trials which are not attractive to big pharma. It was very difficult and time consuming to activate an academic clinical trial, for this reason, a study may become “old” as new drugs entered into the market. National institutions should promote the development of clinical research infrastructures and network with competence in regulatory, ethical, and legal skills to speed up academic research.
KW - academic
KW - ERANET
KW - PET
KW - radiopharmaceuticals
KW - regulatory in Europe
U2 - 10.3389/fmed.2021.817678
DO - 10.3389/fmed.2021.817678
M3 - Article
AN - SCOPUS:85123778251
SN - 2095-0217
VL - 8
JO - Frontiers in Medicine
JF - Frontiers in Medicine
M1 - 817678
ER -