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Poster display session

1448 - Academic Clinical Research: enough players to get out there?


10 Sep 2017


Poster display session


Cancers in Adolescents and Young Adults (AYA);  Bioethical Principles and GCP


Celeste Cagnazzo


Annals of Oncology (2017) 28 (suppl_5): v511-v520. 10.1093/annonc/mdx385


C. Cagnazzo1, S. Campora2, S. Pirondi3, G. Gentili4, A. Guarrera5, C. Taverniti6, M. Manuela4

Author affiliations

  • 1 -, Gruppo Italiano Data Manager (GIDM), - - Meldola/IT
  • 2 -, ICON plc, - - Milan/IT
  • 3 Na, Ospedale di Sassuolo, 41049 - Sassuolo/IT
  • 4 Unità Di Biostatistica E Sperimentazioni Cliniche, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), 47014 - Meldola/IT
  • 5 Na, AOU Careggi, 50134 - Firenze/IT
  • 6 Medical Oncology, AOU Citta della Salute e della Scienza di Torino, 10126 - Torino/IT


Abstract 1448


The European Regulation 536/2014 definitively establishes the equality between pharma-sponsored and academic clinical research, raising the bar of standards for no profit trials. Italy has always been known for the quality of its studies: our researchers have produced the 3.9% of world scientific papers in 2015-16 and 44 were among the 2016 world’s most influential scientific minds. However, the new compelling rules imposed by law make these great minds lacking in the absence of well-arranged staff, with dedicated professionals as clinical research coordinators (CRCs). Unfortunately, the national collective health contracts allow the employment of these experts only through atypical contracts that, due to new government requirements, will soon be banned. We have decided to map how much the problem was widespread among Italian CRCs.


In November 2016 a web survey, focused on the imminent contracts’ expiration problem, has been sent to about 300 CRCs.


Our survey was completed by 231 CRCs (77%). The majority of respondents (78%) work thanks to atypical contracts, while few can count on more stable ones (7.4% fixed term and 14.6% open-ended). Public hospitals have the more difficulties to ensure stable employment: only 25% of permanent contracts come from this type of structures and purely thanks to loopholes; indeed, despite their educational background, CRCs are employed almost exclusively as non-qualified administrative personnel. The 67.5% of respondents will be affected by the contract problem, with multiple expiration timing: 32% Jan-Apr 17; 23% May-Aug 17; 23% Sep-Dec 17; 17.3% from Jan 18. Interestingly, about 50 CRCs were unwilling to participate, demoralized from the age-issue of the lack of professional recognition.


The need for clinical trials units officially and contractually recognized by competent authorities is a priority. The new government dispositions about atypical contracts could create a vacuum of skilled work force, which can hardly be covered by physicians. Since data are understated and the problem also affects another “big ghost” of clinical research (study nurse), in the absence of a permanent solution, Italy is unlikely to meet the required standards with a loss of appealing, but mostly with a slump of therapeutic options.

Clinical trial identification

Legal entity responsible for the study

Gruppo Italiano Data Manager (GIDM)




All authors have declared no conflicts of interest.

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