Clinical research: the great absentee of the Italian University training programs?

Authors

  • Stefano Stabile Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano - Italy and Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola - Italy https://orcid.org/0000-0003-0040-485X
  • Veronica Franchina Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola - Italy and U.O.C. Oncologia Medica A.O. Papardo, Messina - Italy
  • Rosita Cenna Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola - Italy https://orcid.org/0000-0001-9648-4000
  • Valentina Sinno Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola - Italy
  • Francesca Mannozzi Gruppo Italiano Data Manager e Coordinatori di Ricerca Clinica (GIDMcrc), Meldola - Italy 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 - Italy 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 - Italy 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 - Italy and SC Oncoematologia Pediatrica, Presidio Ospedaliero Infantile Regina Margherita, AOU Città della Salute e della Scienza di Torino, Torino - Italy https://orcid.org/0000-0003-4055-3139

DOI:

https://doi.org/10.33393/ao.2023.2566

Abstract

Background: In an era where clinical trials have become more and more complex and regulatory authorities impose very high quality standards, the education of clinical research professionals becomes crucial. As one of ICH-GCP guiding principles, adequate training should be ensured and included in educational programs.

Methods: In 2021, the Italian Group of Data Managers and Clinical Research Coordinators shared among professionals involved in clinical research an online survey aimed at investigating quality and characteristics of clinical research training provided during undergraduate and postgraduate Italian programs.

Results: The survey was completed by 280 professionals: 178 study coordinators, 29 clinical research associates, 20 project managers, 7 study nurses, and 44 others. The majority were 25-45 years old (n = 242, 86.4%), worked at experimental sites (n = 211, 75.4%), and almost all (n = 252, 90.0%) had at least a master’s degree, mainly in biology/biotechnology (n = 162, 57.9%) and pharmacy (n = 64, 22.9%). Clinical research education during the degree courses was considered poor by 73.6% (n = 206). The knowledge on clinical research professional world at the time of graduation was considered poor by 71.1% of participants (n = 199), like the knowledge of related career opportunities (71.1%, n = 199, poor). According to 85.0% of professionals (n = 238) additional postgraduate trainings were needed, mainly university master courses (47.50%, n = 133) and private institution courses (47.86%, n = 134). Postgraduate trainings were considered very useful by 71.4% (n = 200) of responders.

Conclusion: Our data suggest undergraduate programs on clinical research education failing at providing even the basic information on clinical research. Therefore, most professionals resort to specific additional postgraduate courses.

Downloads

Download data is not yet available.

References

Samuels E, Ianni PA, Chung H, et al. Practical tips and/or guidelines Open Access Guidelines for Evaluating Clinical Research Training using Competency Assessments [Version 2]. MedEdPublish. 2019;8(3). https://doi.org/10.15694/mep.2019.000202.2 DOI: https://doi.org/10.15694/mep.2019.000202.2

Bechtel J, Chuck T, Forrest A, et al. Improving the quality conduct and efficiency of clinical trials with training: recommendations for preparedness and qualification of investigators and delegates. Contemp Clin Trials. 2020;89:105918. https://doi.org/10.1016/j.cct.2019.105918PMID:31881391 DOI: https://doi.org/10.1016/j.cct.2019.105918

Guideline for good clinical practice E6(R2) Step 5 – Committee for Human Medicinal Products, 1 December 2016 EMA/CHMP/ICH/135/1995. Online https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-good-clinical-practice-e6r2-step-5_en.pdf. Accessed January 2023.

Swezey T, McGuire FH, Hurley P, et al. More than a box to check: research sponsor and clinical investigator perspectives on making GCP training relevant. Contemp Clin Trials Commun. 2020;19:100606. https://doi.org/10.1016/j.conctc.2020.100606 PMID:32817904 DOI: https://doi.org/10.1016/j.conctc.2020.100606

Magnin A, Iversen VC, Calvo G, et al. European survey on national training activities in clinical research. Trials. 2019;20(1):616. https://doi.org/10.1186/s13063-019-3702-z PMID:31665085 DOI: https://doi.org/10.1186/s13063-019-3702-z

Decreto Ministeriale del 15 novembre 2011. Definizione dei requisiti minimi per le organizzazioni di ricerca a contratto (CRO) nell’ambito delle sperimentazioni cliniche di medicinali. Gazzetta Ufficiale n. 11 del 14 gennaio 2012. Online https://www.gazzettaufficiale.it/eli/id/2012/01/14/12A00319/sg. Accessed January 2023.

Determina AIFA 809 del 19 giugno 2015 – Determina inerente i requisiti minimi necessari per le strutture sanitarie che eseguono sperimentazioni di fase I (GU Serie Generale n. 15 8 del 10.07.2015). Online https://www.gazzettaufficiale.it/eli/id/2015/07/10/15A05315/sg. Accessed January 2023.

Rapporto Ispezioni GCP 2015-2017: Classificazione e analisi delle deviazioni alla Good Clinical Practice. Agenzia Italiana del Farmaco (AIFA). Online https://www.aifa.gov.it/-/rapporto-ispezioni-gcp-2015-2017-classificazione-e-analisi-delle-deviazioni-alla-good-clinical-practi-2. Accessed January 2023.

Annual Report of the Good Clinical Practice Inspectors’ Working Group 2019 – 5 February 2021 EMA/INS/GCP/588463/2020. Inspections Office Quality and Safety of Medicines Department – European Medicines Agency; 2020. Online https://www.ema.europa.eu/en/documents/report/annual-report-good-clinical-practice-inspectors-working-group-2019_en.pdf. Accessed January 2023.

FDA Data Dashboard. Inspections. Online https://datadashboard.fda.gov/ora/cd/inspections.htm. Accessed January 2023.

Alfaar AS, Hassan WM, Bakry MS, Ezzat S. Clinical Research Recession: Training Needs Perception Among Medical Students. J Cancer Educ. 2017;32(4):728-733. https://doi.org/10.1007/s13187-016-0995-4 PMID:26847465 DOI: https://doi.org/10.1007/s13187-016-0995-4

LEGGE 11 gennaio 2018, n. 3 : Delega al Governo in materia di sperimentazione clinica di medicinali nonche' disposizioni per il riordino delle professioni sanitarie e per la dirigenza sanitaria del Ministero della salute. (GU Serie Generale n.25 del 31-01-2018). Online https://www.gazzettaufficiale.it/eli/id/2018/1/31/18G00019/sg. Accessed January 2023.

Loiodice I, Dato D. I servizi di orientamento universitario (in entrata, in itinere, in uscita) per il successo formativo, l'inclusione sociale e l'occupabilità in Successo formativo, inclusione e coesione sociale: strategie innovative. 2017. Armando Editore, Roma. Online https://fair.unifg.it/handle/11369/354182#?mode=complete. Accessed January 2023.

Cunti A, Priore A. Prefigurarsi il lavoro. L’orientamento universitario tra ricerca, didattica e formazione. Educational Reflective Practices. 2020;2:178-195. Online https://www.francoangeli.it/riviste/Scheda_rivista.aspx?IDArticolo=67906. Accessed January 2023. DOI: https://doi.org/10.3280/ERP2020-002011

La Sperimentazione Clinica dei Medicinali in Italia – 19° Rapporto Nazionale AIFA. Anno; 2020. AIFA. Online https://www.aifa.gov.it/-/19-rapporto-nazionale-sulla-sperimentazione-clinica-dei-medicinali-in-italia-20-1. Accessed January 2023.

Published

2023-04-28

How to Cite

Stabile, S., Franchina, V., Cenna, R., Sinno, V., Mannozzi, F., Federici, I., Testoni, S., & Cagnazzo, C. (2023). Clinical research: the great absentee of the Italian University training programs?. AboutOpen, 10(1), 64–68. https://doi.org/10.33393/ao.2023.2566

Issue

Section

Original research articles

Categories

Received 2023-01-28
Accepted 2023-04-03
Published 2023-04-28

Metrics