Time spent for activation of non-profit studies in oncology in Italy.
Time spent for activation of non-profit studies in oncology in Italy.
Blog Article
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 Top / Bottom Oven Element 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 Bike Parts - Derailleurs - Front 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 non-profit clinical trials in Italy, but the whole process still remains inefficient.
Efforts should be made to improve the process, also focusing on administrative procedures.