Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research

Journal of Medical Ethics

Volumn 41, Issue 10, 2015, Pages 799-803

  De Feo, Gianfranco ^a   Frontini, Luciano ^b   Rota, Silvia ^b   Pepe, Antonio ^c   Signoriello, Simona ^d   Labianca, Roberto ^e   Sobrero, Alberto ^f   De Placido, Sabino ^c   Perrone, Francesco ^a  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b GISCAD Foundation   (Italy)

^c UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^d SECOND UNIVERSITY OF NAPLES   (Italy)

^e OSPEDALI RIUNITI   (Italy)

^f UNIVERSITY OF GENOA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; FLUOROURACIL; FOLINIC ACID; PLATINUM COMPLEX;

BREAST NEOPLASMS; CLINICAL TRIAL (TOPIC); COLORECTAL NEOPLASMS; FEMALE; HUMAN; ITALY; MALE; MULTICENTER STUDY (TOPIC); PROFESSIONAL STANDARD; QUALITY CONTROL; STANDARDS; TIME FACTOR;

ANTINEOPLASTIC AGENTS, HORMONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENCHMARKING; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; COLORECTAL NEOPLASMS; ETHICS COMMITTEES; FEMALE; FLUOROURACIL; HUMANS; ITALY; LEUCOVORIN; MALE; MULTICENTER STUDIES AS TOPIC; ORGANOPLATINUM COMPOUNDS; TIME FACTORS;

EID: 84942295492     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/medethics-2012-100803     Document Type: Article

References (12)

1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities 1-5-2001, L 121/34-44.
2. Legislative Decree no. 211 of 24th June 2003. Transposition of Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for clinical use. Ordinary SUPPLement of Italian Official Journal no. 184 of 9/8/2003.
3. Ministerial Decree 17th December 2004. Prescriptions and conditions of a general nature referring to the conduct of clinical trials of medicines with special reference to those designed to enhance clinical practice as an integral part of health and medical care. Italian Official Journal no. 43 of 22/2/2005.
4. Ministerial Decree 21st December 2007. Directions for submitting the request for authorisation of a clinical trial on a medicinal product for human use to the Competent Authority, for communicating substantial amendments, for declaring the end of the trial and for the request of an opinion to the Ethics Committee. Ordinary SUPPLement of Italian Official Journal no. 53 of 3/3/2008.
5. Porcu L, Poli D, Torri V, et al. Impact of recent legislative bills regarding clinical research on Italian ethics committee activity. J Med Ethics 2008;34:747-50.
6. De Feo G, Signoriello S, Bryce JC, et al. Time spent for activation of non-profit studies in oncology in Italy. PLoS ONE 2010;5:e11864.
7. Italian Medicines Agency (AIFA). Bulletin of clinical trials of drugs in Italy, 2011. http://oss-sper-clin.agenziafarmaco.it
8. Duley L, Antman K, Arena J, et al. Specific barriers to the conduct of randomised trials. Clin Trials 2008;5:40-8.
9. Dilts DM, Sandler AB. Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol 2006;24:4545-52.
10. Dilts DM, Sandler AB, Cheng SK, et al. Steps and time to process clinical trials at the Cancer Therapy Evaluation Program. J Clin Oncol 2009;27:1761-6.
11. Stewart DJ, Whitney SN, Kurzrock R. Equipoise lost: ethics, costs, and the regulation of cancer clinical research. J Clin Oncol 2010;28:2925-35.
12. Ministerial Decree 7th November 2008. Changes and additions to the decrees of March 19, 1998, on «Identification of suitability centers for clinical trials on medicinal products»; May 8, 2003, on «Therapeutic use of drugs undergoing clinical trials» and, May 12, 2006, on «Requirements for establishment, organization and functioning of Ethics Committees for clinical trials on medicinal product». Italian Official Journal no. 80 of 6/4/2009.