Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review

By Krzysztof Smigorski, PhD, Magdalena Perez, PhD, and Kristi Bertzos, PhD, INC Research/inVentiv Health

One of the factors contributing to the risk for sponsor companies in analgesic trials is the difficulty in measuring the severity of pain symptoms during trials in a valid and reliable way. The experience of pain is, of course, subjective and is more receptive to placebo response than any other symptom (Gracely, 2009; Berthelot, 2011). Meanwhile, the scientific community has conflicting views on the validity and reliability of Patient-Reported Outcome (PRO) assessments gathered directly from patients. Read how sponsors can ensure that PRO assessments are scientifically sound and will support evidence requirements for marketing approval and reimbursement. Part one of a two part series.