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

Publication date: Available online 9 January 2020Source: Trends in Pharmacological SciencesAuthor(s): David Borsook, Jaymin Upadhyay, Richard Hargreaves, Tor WagerThe 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.

Source: Trends in Pharmacological Sciences - January 10, 2020 Category: Drugs & Pharmacology Source Type: research