Time spent for activation of non-profit studies in oncology in Italy

Gianfranco de Feo, Simona Signoriello, Jane C. Bryce, Antonia del Giudice, Giuliana Canzanella, Federika Crudele, Fiorella Romano, Giovanni de Matteis, Manuela Florio, Fabiano Falasconi, Alfonso Savio, Pasqualina Giordano, Gennaro Daniele, Mario Iaccarino, Maria Carmela Piccirillo, Massimo di Maio, Alessandro Morabito, Ciro Gallo, Francesco Perrone

Research output: Contribution to journalArticle

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Abstract

Aim: The aim of this paper is to describe the time spent to activate oncological non-profit clinical trials promoted in Italy by the National Cancer Institute of Naples, following the implementation of recent European laws. Methodology: Data about the process of activation of 5 non-profit multicentre clinical trials were prospectively collected through a web-based system. The impact of European guidelines was assessed by comparing the efficiency of the process between applications started before and after the decree introducing in Italy the Clinical Trial Application form (MD-CTA). Outcomes of the descriptive analyses were the time to EC opinion, the time to administrative agreement signature after a positive EC opinion, and the cumulative percentage of submissions that came to closure (either positive or negative) within four subsequent time cohorts. Principal Findings: From March 2007 to October 2009, 202 applications were submitted to 107 centres. Forty-four (59%) applications of those submitted before were successful, compared to 71 (55%) of those submitted after MD-CTA. Most of the failures were due to missing EC response (27% and 22%) or administrative reasons (10% and 16%, before and after, respectively);very few (4% and 7%) were due to EC refusal. The impact of the MD-CTA on time to EC opinion looked positive (median 4.1 vs 2.4 months, before and after, respectively) but a subgroup analysis revealed that the impact was limited to a comparison biased by the selection of EC. After a positive EC opinion, there was no difference before and after MD-CTA in the time to administrative agreement signature (median 3.6 and 3.8 months, respectively). A trend to shortening time to closure of the whole submission process over the time was evident, with 58% of the applications coming to closure within 6 months from submission in the most recent cohort. Conclusions: In our experience there is reassuring evidence of a trend toward shortening the time spent to activate nonprofit clinical trials in Italy, but the whole process still remains inefficient. Efforts should be made to improve the process, also focusing on administrative procedures.

Original languageEnglish
Article numbere11864
JournalPLoS One
Volume5
Issue number7
DOIs
Publication statusPublished - 2010

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Oncology
Italy
clinical trials
Chemical activation
shortenings
Clinical Trials
neoplasms
National Cancer Institute (U.S.)
Multicenter Studies
Guidelines
methodology

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

de Feo, G., Signoriello, S., Bryce, J. C., del Giudice, A., Canzanella, G., Crudele, F., ... Perrone, F. (2010). Time spent for activation of non-profit studies in oncology in Italy. PLoS One, 5(7), [e11864]. https://doi.org/10.1371/journal.pone.0011864

Time spent for activation of non-profit studies in oncology in Italy. / de Feo, Gianfranco; Signoriello, Simona; Bryce, Jane C.; del Giudice, Antonia; Canzanella, Giuliana; Crudele, Federika; Romano, Fiorella; de Matteis, Giovanni; Florio, Manuela; Falasconi, Fabiano; Savio, Alfonso; Giordano, Pasqualina; Daniele, Gennaro; Iaccarino, Mario; Piccirillo, Maria Carmela; di Maio, Massimo; Morabito, Alessandro; Gallo, Ciro; Perrone, Francesco.

In: PLoS One, Vol. 5, No. 7, e11864, 2010.

Research output: Contribution to journalArticle

de Feo, G, Signoriello, S, Bryce, JC, del Giudice, A, Canzanella, G, Crudele, F, Romano, F, de Matteis, G, Florio, M, Falasconi, F, Savio, A, Giordano, P, Daniele, G, Iaccarino, M, Piccirillo, MC, di Maio, M, Morabito, A, Gallo, C & Perrone, F 2010, 'Time spent for activation of non-profit studies in oncology in Italy', PLoS One, vol. 5, no. 7, e11864. https://doi.org/10.1371/journal.pone.0011864
de Feo G, Signoriello S, Bryce JC, del Giudice A, Canzanella G, Crudele F et al. Time spent for activation of non-profit studies in oncology in Italy. PLoS One. 2010;5(7). e11864. https://doi.org/10.1371/journal.pone.0011864
de Feo, Gianfranco ; Signoriello, Simona ; Bryce, Jane C. ; del Giudice, Antonia ; Canzanella, Giuliana ; Crudele, Federika ; Romano, Fiorella ; de Matteis, Giovanni ; Florio, Manuela ; Falasconi, Fabiano ; Savio, Alfonso ; Giordano, Pasqualina ; Daniele, Gennaro ; Iaccarino, Mario ; Piccirillo, Maria Carmela ; di Maio, Massimo ; Morabito, Alessandro ; Gallo, Ciro ; Perrone, Francesco. / Time spent for activation of non-profit studies in oncology in Italy. In: PLoS One. 2010 ; Vol. 5, No. 7.
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abstract = "Aim: The aim of this paper is to describe the time spent to activate oncological non-profit clinical trials promoted in Italy by the National Cancer Institute of Naples, following the implementation of recent European laws. Methodology: Data about the process of activation of 5 non-profit multicentre clinical trials were prospectively collected through a web-based system. The impact of European guidelines was assessed by comparing the efficiency of the process between applications started before and after the decree introducing in Italy the Clinical Trial Application form (MD-CTA). Outcomes of the descriptive analyses were the time to EC opinion, the time to administrative agreement signature after a positive EC opinion, and the cumulative percentage of submissions that came to closure (either positive or negative) within four subsequent time cohorts. Principal Findings: From March 2007 to October 2009, 202 applications were submitted to 107 centres. Forty-four (59{\%}) applications of those submitted before were successful, compared to 71 (55{\%}) of those submitted after MD-CTA. Most of the failures were due to missing EC response (27{\%} and 22{\%}) or administrative reasons (10{\%} and 16{\%}, before and after, respectively);very few (4{\%} and 7{\%}) were due to EC refusal. The impact of the MD-CTA on time to EC opinion looked positive (median 4.1 vs 2.4 months, before and after, respectively) but a subgroup analysis revealed that the impact was limited to a comparison biased by the selection of EC. After a positive EC opinion, there was no difference before and after MD-CTA in the time to administrative agreement signature (median 3.6 and 3.8 months, respectively). A trend to shortening time to closure of the whole submission process over the time was evident, with 58{\%} of the applications coming to closure within 6 months from submission in the most recent cohort. Conclusions: In our experience there is reassuring evidence of a trend toward shortening the time spent to activate nonprofit clinical trials in Italy, but the whole process still remains inefficient. Efforts should be made to improve the process, also focusing on administrative procedures.",
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AU - de Feo, Gianfranco

AU - Signoriello, Simona

AU - Bryce, Jane C.

AU - del Giudice, Antonia

AU - Canzanella, Giuliana

AU - Crudele, Federika

AU - Romano, Fiorella

AU - de Matteis, Giovanni

AU - Florio, Manuela

AU - Falasconi, Fabiano

AU - Savio, Alfonso

AU - Giordano, Pasqualina

AU - Daniele, Gennaro

AU - Iaccarino, Mario

AU - Piccirillo, Maria Carmela

AU - di Maio, Massimo

AU - Morabito, Alessandro

AU - Gallo, Ciro

AU - Perrone, Francesco

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N2 - Aim: The aim of this paper is to describe the time spent to activate oncological non-profit clinical trials promoted in Italy by the National Cancer Institute of Naples, following the implementation of recent European laws. Methodology: Data about the process of activation of 5 non-profit multicentre clinical trials were prospectively collected through a web-based system. The impact of European guidelines was assessed by comparing the efficiency of the process between applications started before and after the decree introducing in Italy the Clinical Trial Application form (MD-CTA). Outcomes of the descriptive analyses were the time to EC opinion, the time to administrative agreement signature after a positive EC opinion, and the cumulative percentage of submissions that came to closure (either positive or negative) within four subsequent time cohorts. Principal Findings: From March 2007 to October 2009, 202 applications were submitted to 107 centres. Forty-four (59%) applications of those submitted before were successful, compared to 71 (55%) of those submitted after MD-CTA. Most of the failures were due to missing EC response (27% and 22%) or administrative reasons (10% and 16%, before and after, respectively);very few (4% and 7%) were due to EC refusal. The impact of the MD-CTA on time to EC opinion looked positive (median 4.1 vs 2.4 months, before and after, respectively) but a subgroup analysis revealed that the impact was limited to a comparison biased by the selection of EC. After a positive EC opinion, there was no difference before and after MD-CTA in the time to administrative agreement signature (median 3.6 and 3.8 months, respectively). A trend to shortening time to closure of the whole submission process over the time was evident, with 58% of the applications coming to closure within 6 months from submission in the most recent cohort. Conclusions: In our experience there is reassuring evidence of a trend toward shortening the time spent to activate nonprofit clinical trials in Italy, but the whole process still remains inefficient. Efforts should be made to improve the process, also focusing on administrative procedures.

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