Patient Voice in Clinical Trial Outcome Assessments

Rahul Dhanda¹* and Gurdyal Kalsi²

Published: Published: July 01, 2022

DOI: 10.55162/MCMS.03.054

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Abstract  

     Since the early 90s, there has been an increasing interest in incorporating clinical outcome assessment (COA) in clinical trials to measure how a patient feels or functions when describing the treatment benefit (both positive or negative) of an intervention. In 2009, the FDA issued the Patient Reported Outcome (PRO) Guidance which lays out the criteria for establishing the ‘fit for purpose’ of a COA, if that COA is to be used along the regulatory pathway (i.e., support approval or labeling). The principles elucidated in the PRO Guidance establish the gold standard for incorporating a COA, and provides the basis for the reliability, validity and interpretability of the COA data collected from a clinical trial on a registration path.

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