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 language | English |
|---|---|
| Article number | e11864 |
| Journal | PLoS One |
| Volume | 5 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - 2010 |
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ASJC Scopus subject areas
- Agricultural and Biological Sciences(all)
- Biochemistry, Genetics and Molecular Biology(all)
- Medicine(all)
Cite this
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 journal › Article
}
TY - JOUR
T1 - Time spent for activation of non-profit studies in oncology in Italy
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
PY - 2010
Y1 - 2010
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.
AB - 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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U2 - 10.1371/journal.pone.0011864
DO - 10.1371/journal.pone.0011864
M3 - Article
C2 - 20686686
AN - SCOPUS:77955626801
VL - 5
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 7
M1 - e11864
ER -