Critical Analysis of Non-profit Clinical Trials: Three Years of Activity at the Clinical Trials Office

References

1. Ministerial Decree of 30 November 2021, Measures to facilitate and support the implementation of non-profit clinical trials of medicinal products and observational studies and to regulate the transfer of data and results of non-profit trials for registration purposes, pursuant to art. 1, paragraph 1, letter c), of the Legislative Decree of 14 May.2021Available From: https://www.gazzettaufficiale.it/eli/id/2022/02/19/22A01189/sg
2. AIFA website. 20th National Report on Clinical Trials of Medicines in Italy 2023.2023Available From: https://www.aifa.gov.it/-/20-rapporto-nazionale-sulla-sperimentazione-clinica-dei-medicinali-in-italia-2023
3. Clinical Trials Information System (CTIS) interface.Available From: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en
4. AIFA website. Osservatorio nazionale Sperimentazione Clinica (OsSC).Available From: https://www.aifa.gov.it/osservatorio-nazionale-sperimentazione-clinica
5. Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance.2014Available From: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536
6. AIFA website. Open Data delle Sperimentazioni Cliniche Farmacologiche (SC) presenti in OsSC dal secondo semestre del 2018.2018Available From: https://www.aifa.gov.it/en/sperimentazioni-cliniche
7. Legislative Decree 24 June 2003, n. 211, Implementation of Directive 2001/20/EC on the application of good clinical practice in the conduct of clinical trials of medicinal products for clinical use, Official Journal General Series n.184 of 09 August 2003 - Ordinary Supplement n. 130.2003Available From: https://www.gazzettaufficiale.it/eli/id/2003/08/09/003G0229/sg
8. Law 11 January 2018, n. 3, Delegation to the Government on clinical trials of medicinal products as well as provisions for the reorganization of health professions and for the health management of the Ministry of Health. (18G00019) (GU General Series n.25 of 31-01-2018).2018Available From: https://www.gazzettaufficiale.it/eli/id/2018/1/31/18G00019/sg
9. Legislative Decree 14 May 2019, n. 52, Implementation of the delegation for the reorganisation and reform of the legislation on clinical trials of medicinal products for human use, pursuant to Article 1, paragraphs 1 and 2, of Law 11 January 2018, n. 3. (19G00059) (GU General Series n.136 of 12-06-2019).2019Available From: https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2019-06-12&atto.codiceRedazionale=19G00059&elenco30giorni=true
10. Ministerial Decree 1 February 2022 Identification of national ethics committees. (22A01630) (GU General Series n.63 of 16-03-2022).2022Available From: https://www.gazzettaufficiale.it/eli/id/2022/03/16/22A01630/sg
11. Ministerial Decree 26 January 2023, Identification of forty territorial ethics committees. (23A00852) (GU General Series n.31 of 07-02-2023).2023Available From: www.gazzettaufficiale.it/eli/id/2023/02/07/23A00852/sg
12. Ministerial Decree of 27 January 2023, Regulation of the transitional phase pursuant to Article 2, paragraph 15, of Law 11 January 2018, no. 3, in relation to the evaluation activities and methods of interaction between the Coordination Centre, the territorial ethics committees, the national ethics committees and the Italian Medicines Agency. (23A00851) (GU General Series no. 31 of 07-02-2023).2023Available From: https://www.gazzettaufficiale.it/eli/id/2023/02/07/23A00851/SG
13. Ministerial Decree of 30 January 2023, Determination of the single fee for clinical trials, the attendance fee and the reimbursement of expenses for participation in the meetings of the National Coordination Centre of the Territorial Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices, of the Territorial Ethics Committees and of the National Ethics Committees. (23A00850) (GU General Series no. 31 of 07-02-2023).2023Available From: https://www.gazzettaufficiale.it/eli/id/2023/02/07/23A00850/sg
14. FADOI’s Manifesto2023Available From: https://www.fadoi.org/wp-content/uploads/2023/09/FADOI_Manifesto-Ricerca-2023.pdf
15. del ÁlamoM. BührerC. FisherD. GrieseM. LingorP. PalladiniG. SireauN. HivertV. SangiorgiL. GuillotF. HalftermeyerJ. SouckováL. NoskováK. DemlováR. Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: An analysis of six use cases.Trials202223178310.1186/s13063‑022‑06713‑y36109818
    [Google Scholar]
16. AIFA website. Technical and advisory committees.Available From: https://www.aifa.gov.it/en/commissioni-tecnico-consultive#:~:text=Commissione%20Tecnico%20Scientifica%20(CTS),determina%20il%20rapporto%20costo%2Defficacia
17. EMA, European Medicines Agency. A call to pool EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19.Available From: https://www.ema.europa.eu/en/documents/other/call-pool-eu-research-resources-large-scale-multi-centre-multi-arm-clinical-trials-against-covid-19_en.pdf
    [Google Scholar]
18. EMA, European Medicines Agency website. Multinational clinical trials by non-commercial sponsors.Available From: https://accelerating-clinical-trials.europa.eu/our-work/multinational-clinical-trials-non-commercial-sponsors_en