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Papers of the Week

Papers: 11 Jan 2020 - 17 Jan 2020

Pharmacology/Drug Development

2020 02

Trends Pharmacol Sci



Enhancing Choice and Outcomes for Therapeutic Trials in Chronic Pain: N-of-1 + Imaging (+ i).


Borsook D, Upadhyay J, Hargreaves R, Wager T
Trends Pharmacol Sci. 2020 02; 41(2):85-98.
PMID: 31928747.


The attrition of novel analgesic drugs in the clinic can be attributed in the main to two factors: failure of preclinical research findings translating into human pain conditions, and a drop-off of efficacy between proof-of-concept (i.e., Phase II trials) and pivotal, confirmatory (Phase III trials) testing. In order to enhance the efficiency of the clinical drug evaluation process and determine rapidly whether a potential therapeutic candidate gives pain relief, by modulating central pain neurobiology, we propose a 'pre-proof-of-concept' approach, in which an efficacy assessment is performed in a single individual (N-of-1) using subjective clinical pain assessments supported by objective validated functional neuroimaging measures. Using an N-of-1 + i methodology, clinical- and neuroimaging-based metrics can be quantified under conditions of drug versus placebo or drug versus current standard of care conditions.