321P - The new European Clinical Trial Regulation: Perception and expectations in Italy

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Bioethics, Legal, and Economic Issues
Presenter Celeste Cagnazzo
Citation Annals of Oncology (2016) 27 (6): 100-102. 10.1093/annonc/mdw366
Authors C. Cagnazzo1, S. Campora2, F. Arizio3, E. Marchesi4
  • 1Oncologia Medica 1, Istituto di Candiolo-IRCCS-Fondazione Piemontese per la Ricerca sul Cancro-Onlus, 10060 - Candiolo/IT
  • 2Medicina Nucleare, Ente Ospedaliero Ospedali Galliera, Genova/IT
  • 3Oncologia Polmonare, Azienda Ospedaliero-Universitaria ASOU San Luigi Gonzaga, Orbassano/IT
  • 4Clinical Trial Unit, Italian Sarcoma Group, Bologna/IT

Abstract

Background

In the last decade Europe has faced a sharp slowdown in Clinical Research (CR) mainly due to European Directive 2001/20/CE application. Consequently the European Commission enacted the EU Regulation 536/2014 (ER) that is expected to become effective only in 2018, due to delays in the portal development. To investigate the ER perception and knowledge of the Italian professionals, two online surveys, addressed to Clinical Research Coordinators (CRCs) and Clinical Investigators (CIs), were conducted.

Methods

Two anonymous web-based surveys, both consisting of 17 questions, have been used.

Results

The 62.5% and 58.9% of the contacted CIs and CRCs respectively answered to the survey: 12% of the CIs have a fully knowledge of the incoming ER while many are only partially (64%) or not (24%) informed. 80.4% of CRCs demonstrate a complete knowledge and are already trained. Amongst the evaluated topics, the need of a Reporting Member State in the first stage of the evaluation process is considered as positive by 74% of the CIs and almost all (90%) believe that this procedure will reduce the approval time. With regards to newly imposed transparency standards, 86% of the CIs would welcome the publication of trial results, while 14% believes that this obligation should only apply to profit trials. Overall 70% of CIs state that staff site's facilities already met all of the ER imposed qualification. The 50% of CIs foresee that the ER will promote independent CR while 42% supposes that it will essentially affect the profit trials. Even though 71.4% of CRCs do not have a definite opinion on ER, 85.7% is convinced that it will have a direct impact on their job.

Conclusions

The ER is a turning point for European CR: it is designed to ensure faster procedures, with positive effects both on timing and overall costs and it will require a rigorous methodology and an increased quality. The surveys highlighted different opinions among CIs and CRCs on Italian ability to rise to this challenge: while CIs believe that the centers already met the imposed requirements with only an initial period of transition, CRCs are less optimistic. This process will involve big efforts and resources, but the payback is the opportunity to be on board of innovative treatments for the Italian patients.

Clinical trial identification

not applicable

Legal entity responsible for the study

Institute for Cancer Research and Treatment, Candiolo (TO) - Italy

Funding

None

Disclosure

All authors have declared no conflicts of interest.