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J Clin Oncol. 2010 Aug 20;28(24):3803-7. doi: 10.1200/JCO.2010.28.1824. Epub 2010 Jul 19.

Time to activate lung cancer clinical trials and patient enrollment: a representative comparison study between two academic centers across the atlantic.

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1
Washington University School of Medicine, St Louis, MO 63110, USA.

Abstract

PURPOSE:

Activation of clinical trials is a lengthy process. We studied the procedures and time required to activate lung cancer clinical trials in a US academic center compared with a European center.

METHODS:

A retrospective review was performed of all thoracic oncology therapeutic trials submitted for regulatory review between 2001 and 2008 at Washington University School of Medicine (WUSM; St Louis, MO) and the University of Torino (UT; Torino, Italy). A process map was drafted by both institutions to establish the order of required events.

RESULTS:

We reviewed 137 therapeutic thoracic oncology trials from WUSM (n = 83) and UT (n = 54). The median times from submission to opening a trial were 163 days for WUSM and 112.5 days for UT (P = .048). The median times for regulatory approval were 75 days for WUSM and 31 days for UT (P < .001). The difference is more pronounced in a homogeneous subset of phase II, industrial-sponsored trials for the median calendar time from submission to opening a trial (239.5 days for WUSM v 112.5 days for UT; P < .001) and time for regulatory approval (99 days for WUSM v 13.5 days for UT; P < .001). The median number of patients accrued at WUSM was 7.4 patients per study compared with an average of 37 patients per study at UT. The proportion of trials that enrolled 20 patients or more represented 22.2% of trials at UT but only 1.1% of trials at WUSM.

CONCLUSION:

It takes additional steps and significantly longer time to activate a therapeutic thoracic clinical trial at a representative US site (WUSM) compared with a European site (UT).

Comment in

PMID:
20644091
DOI:
10.1200/JCO.2010.28.1824
[Indexed for MEDLINE]
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