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European Journal of Clinical Pharmacology

, Volume 75, Issue 10, pp 1415–1420 | Cite as

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

  • Nicola MontanaroEmail author
  • Giulia Bonaldo
  • Stefania Proni
  • Giacomo Chiabrando
  • Domenico Motola
Pharmacoepidemiology and Prescription
  • 50 Downloads

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.

Keywords

Clinical trials regulation Non-commercial trials Non-profit organizations Pharmaceutical industry Ethics committee 

Notes

Author’s 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.

Compliance with ethical standards

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.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.University of BolognaBolognaItaly
  2. 2.Unit of Pharmacology, Department of Medical and Surgical SciencesUniversity of BolognaBolognaItaly
  3. 3.University Hospital St. Orsola-MalpighiBolognaItaly

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