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Reproducibility in pre-clinical drug efficacy studies: results of an ACTTION-funded multi-site comparative study.
Topical Workshop
The reproducibility of pre-clinical chronic pain treatment studies has been highlighted as a potential barrier to the translation of basic science research into new pain treatments. In the absence of a well-controlled, multi-site study performed by experienced research groups, real-world reproducibility remains untested. To address this limitation, a pre-clinical multi-site chronic pain treatment study was performed following a protocol developed by a panel of experts representing academia, industry and government. The following design principles were emphasized: a) include multiple independent academic laboratories with extensive experience in chronic pain and analgesic research, b) incorporate current common practices based on a literature survey and c) employ standardized protocols. The study was performed in parallel by seven independent laboratories in the US and Canada in mice using the spared nerve injury (SNI) model and gabapentin (i.p.) and the primary experimental endpoint was mechanical sensitivity using von Frey filaments and the up-down method. All experiments were performed blind. The baseline, post-SNI and post-gabapentin data were assessed for equivalence. Preliminary analyses suggests that despite limited equivalence in baseline and post-SNI, pre-drug sensitivity, drug efficacy and potency were similar across most sites. The implications of these findings regarding reproducibility, experimental design and future directions will be discussed.