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Friday, May 20, 2016
The next step in translational research: lessons learned from the first preclinical randomized controlled trial - How to use for stroke?
For
years, low reproducibility of preclinical trials and poor translation
of promising preclinical therapies to the clinic have posed major
challenges to translational research in most biomedical fields. To
overcome the limitations that stand between experimental and clinical
research, international consortia have attempted to establish
standardized guidelines for study design and for reporting the resulting
data. In addition, multicenter preclinical randomized controlled trials
(pRCTs) have been proposed as a suitable tool for ‘bridging the gap’
between experimental research and clinical trials. We recently reported
the design and results of the first such pRCT in which we confirmed the
feasibility of using a coordinated approach with standardized protocols
in collaboration with independent multinational research centers.
However, despite its successes, this first pRCT also had several
difficulties, particularly with respect to following the protocols
established in the study design and analyzing the data. Here, we review
our experiences performing the study, and we analyze and discuss the
lessons learned from performing the first pRCT. Moreover, we provide
suggestions regarding how obstacles can be overcome to improve the
performance and outcome of future pRCT studies.Translational research is hampered by low reproducibility of
preclinical studies and countless failed clinical trials. International
consortia have proposed preclinical multicenter trials as an
intermediate step to overcome this ‘translational roadblock’. We have
recently performed the first such preclinical randomized controlled
trial (pRCT) by adopting key elements of clinical study design to
preclinical research. In this review, we discuss the lessons learned
from this trial and provide suggestions how to optimize future pRCTs.
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