Time Spent for Activation of Non-Profit Studies in Oncology in Italy

Abstract

AimThe 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.MethodologyData 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 FindingsFrom 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.ConclusionsIn 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.

Cycle Time Metrics for Multisite Clinical Trials in the United States

“…Although specific populations (eg, phase 3 oncology trials) have been studied in depth, such studies have not hitherto been attempted in broader populations that cross therapeutic areas and center-specific processes. 13–21 Thus, the broad scope of the present study allowed us to identify several critical elements that contribute significantly to SSU time.…”

“…Various research articles have explored factors affecting SSU time. [13][14][15][16][17][18][19][20][21] Dilts and colleagues [15][16][17][18][19] examined SSU for cooperative groups involved in oncology trials, rigorously identifying hundreds of distinct processes and working steps and the subsequent decision points, processing loops, and stopping points between concept initiation and trial activation. In a recent publication, Dilts et al 19 noted that improvements to both the quality of the processes and to the time required to develop clinical trials should be made collaboratively and not in isolation.…”

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

“…We have previously shown that the introduction of the so-called CTA form did not shorten time for administrative authorisation 6. Again, structural solutions should be considered, for example inclusion of administrative representatives within IECs who can sign contracts immediately IEC approval is granted 12.…”

Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission

“…Time to trial activation is critical for clinical research. Therefore, major efforts should be made to reduce and standardize procedures concerning the approval of clinical trials [9] .…”