Clinical trial units and clinical research coordinators: a system facing crisis?

Authors

  • Stefano Stabile Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan and Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola - Italy https://orcid.org/0000-0003-0040-485X
  • Rosita Cenna Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and SC Oncoematologia Pediatrica, Presidio Ospedaliero Infantile Regina Margherita, AOU Città della Salute e della Scienza di Torino, Turin - Italy
  • Valentina Sinna Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and SS Clinical Trial Center, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy
  • Franchina Veronica Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and U.O.C. Oncologia Medica A.O. Papardo, Messina - Italy
  • Francesca Mannozzi Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola - Italy
  • Irene Federici Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and Clinica di Ematologia, AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Ancona - Italy
  • Sara Testoni Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola - Italy
  • Celeste Cagnazzo Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola and SC Oncoematologia Pediatrica, Presidio Ospedaliero Infantile Regina Margherita, AOU Città della Salute e della Scienza di Torino, Turin - Italy https://orcid.org/0000-0003-4055-3139

DOI:

https://doi.org/10.33393/ao.2023.2508

Keywords:

Clinical Research, Clinical Research Coordinator, Clinical Trial Management, Clinical Trial Unit

Abstract

We are currently witnessing an increase in procedural and managerial complexities within the field of clinical research, which require greater human and infrastructural resources as well as imply the need for a greater skill set and expertise on the part of professionals. Within this frame of reference clinical trial units and clinical research coordinators play a vital role in the design and conduct of clinical trials in Italy. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the lack of recognition at the Italian institutional level, that lead to precarious work contracts, lack of identity, and excessive turnover at experimental sites. This article, led by the Italian Group of Clinical Research Coordinator (GIDMcrc), presents some of the issues and ways in which national stakeholders may be able to address this.

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Published

2023-01-16

How to Cite

1.
Stabile S, Cenna R, Sinna V, Veronica F, Mannozzi F, Federici I, Testoni S, Cagnazzo C. Clinical trial units and clinical research coordinators: a system facing crisis?. abtpn [Internet]. 2023 Jan. 16 [cited 2023 Feb. 4];10(1):1-3. Available from: https://journals.aboutscience.eu/index.php/aboutopen/article/view/2508
Received 2022-10-24
Accepted 2022-12-19
Published 2023-01-16