Abstract
Purpose
In Italy, the non-commercial trials on medicines are regulated by the Ministry Decree 17 December, 2004. Its intent is of encouraging the independent research for the improvement of clinical practice. We aimed to analyze the main features of the proposals of non-commercial clinical trials on medicines submitted to the Independent Ethics Committee (IEC) of the University Hospital of Bologna in the period 2010–2017.
Methods
Data were extracted from IEC registry and were organized with an ad hoc database. The relationships between the variables were examined using contingency tables. When appropriate, we applied the chi-square statistical test for the comparison of the categorical variables.
Results
Over the 8-year period, the IEC evaluated 2931 studies, of which 1156 (39.4%) related to clinical trials on medicines; 245 (21.2%) out of the latter were non-commercial ones. A percentage of 49.8 of the trials were of phase II; 137 trials (55.9%) were promoted by hospitals, medical schools or institutes for research, hospitalization and health care. Non-profit organizations and scientific societies were promoters of 88 trials (35.9%). Most phase I and phase II trials received additional support from pharmaceutical companies.
Conclusions
Our results show a not negligible industrial influence on non-commercial trials through additional support, mostly to those of phase II. An update of the present legislation on this matter is desirable, adopting clearer rules on the relations sponsor-industry.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Bergmann L, Berns B, Dalgleish AG, Von Euler M, Hecht TT et al (2010 Aug) Investigator-initiated trials of targeted oncology agents: why independent research is at risk? Ann Oncol 21(8):1573–1578. https://doi.org/10.1093/annonc/mdq018
Pushpakom S, Iorio F, Eyers PA, Escott KJ, Hopper S, Wells A, Doig A, Guilliams T, Latimer J, McNamee C, Norris A, Sanseau P, Cavalla D, Pirmohamed M (2018) Drug repurposing: progress, challenges and recommendations. Nat Rev Drug Discov 18:41–58. https://doi.org/10.1038/nrd.2018.168
Directive 2001/20/EC of The European Parliament and of the Council, available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. Accessed 21 Feb 2019
Fuentes Camps I, Rodríguez A, Agustí A Non-commercial vs(2018) Commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee. Br J Clin Pharmacol 84:1384–1388. https://doi.org/10.1111/bcp.13555
Montanaro N. Studi no-profit sui farmaci: è tempo di una normativa 2.0. Evidence, December 2014, volume 6, issue 12, e1000099, available at: https://www.evidence.it/articoli/pdf/e1000099.pdf. Accessed 21 Feb 2019
Ministerial Decree 17.12.2004. Available at http://www.gidm.org/doc/DM_17_dicembre_2004.pdf. Accessed 21 Feb 2019
Document on clinical research by non-profit promoter (2018) available at: https://www.fadoi.org/wp-content/uploads/2018/11/FADOI.CRNP_.2018.Documento.propositivo.FINAL_.pdf. Accessed 21 Feb 2019
Montanaro N, Melis M, Proni S, Chiabrando G, Motola D (2017) Six-year activity on approval of compassionate use of medicines by the Ethics Committee of the University Hospital of Bologna (Italy): time to update rules and recommendations. Eur J Clin Pharmacol 73(4):479–485. https://doi.org/10.1007/s00228-016-2186-y
11th National Report on Clinical Trials of Drugs in Italy, 2012. Available at: http://www.agenziafarmaco.gov.it/sites/default/files/11_rapporto_lug_12_ita_0.pdf. Accessed 26 Oct 2016
12th National Report on Clinical Trials of Drugs in Italy, 2013. http://www.agenziafarmaco.gov.it/sites/default/files/12_Rapporto_dic%2013_ITA.pdf. Accessed 26 Oct 2016
National Monitoring Centre for Clinical Trials (OsSC) available at: http://www.agenziafarmaco.gov.it/content/osservatorio-nazionale-sulla-sperimentazione-clinica-dei-medicinali. Accessed 21 Feb 2019
Remuzzi G, Schieppati A, Boissel JP, Garattini S, Horton R (2004) Independent clinical research in Europe. Lancet 364:1723–1726. https://doi.org/10.1016/S0140-6736(04)17360-1
Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, DeAngelis CD et al (2009) Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA 301(13):1367–1372. https://doi.org/10.1001/jama.2009.407
Ridker PM, Torres J (2006) Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005. JAMA 295(19):2270–2274. https://doi.org/10.1001/jama.295.19.2270
Italian Law 11.01.2018 n. 3, available at: http://www.gazzettaufficiale.it/eli/id/2018/1/31/18G00019/sg. Accessed 21 Feb 2019
Http://www.senato.it/leg/18/BGT/Schede/docnonleg/37870.htm. Accessed 22 Feb 2019
Author information
Authors and Affiliations
Contributions
Contributions to conception or design of the study (NM, DM, GB), analyzed data (NM, GB, SP, GC) or interpretation of data for the work (NM, DM, GC, SP); wrote the paper (NM, GB, DM) or revising it critically for important intellectual content (GC, SP); all the authors approved the submitted final version to be published and all the authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Corresponding author
Ethics declarations
The manuscript does not contain clinical trials or patient data. For this type of study, formal consent is not required but only notification to the Ethics Committee.
Conflict of interest
The authors declare that they have no conflict of interest.
Disclaimer
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the position of the Ethics Committee, where four of us were (NM, DM, GC, SP) or are (GC, SP) in activity.
Additional information
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Montanaro, N., Bonaldo, G., Proni, S. et al. Non-commercial trials on medicines submitted to the Ethics Committee of the University Hospital of Bologna (Italy) along 8 years of activity: time to update rules and recommendations. Eur J Clin Pharmacol 75, 1415–1420 (2019). https://doi.org/10.1007/s00228-019-02706-0
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00228-019-02706-0