Clinical trials considering using patient reported outcome (PRO) measures should develop “validity arguments” to support their use, according to a recent paper published by Duke University researchers and others.

Sponsors should build a publicly accessible repository of validity arguments, or evidence-based arguments for including PRO measures in a trial that resemble evidence in a court case. By doing that, a greater consensus can be reached on what evidence is truly needed to justify their use in clinical research, says the paper, recently published in Health and Quality of Life Outcomes.

Context is critical when determining how much evidence is necessary to justify including a PRO measure, the researchers found. For that reason, constructing evidence-based arguments can help to support inclusion and build up a public repository of validity arguments over time.

The basic premise of a validity argument is providing “a compelling rationale explaining the interpretation and use of a specific patient-reported outcome measure,” the Duke Clinical Research Institute (DCRI) explained.

“The decision that a PRO measure is suitable for a proposed interpretation and use would be made by evaluating the logic, coherence and quality of evidentiary support for the validity argument,” DCRI said.

As PRO measures are employed more often for common conditions like heart failure, a precedent may form for expectations on their inclusion in trials and labeling. Similarly, for rare conditions, building up publicly accessible documentation on context and regulatory acceptance of PRO measure evidence will offer clarity in the future, the researchers said.

Read the full paper here: https://bit.ly/3AdDl8P.