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# Assessing Clinical Benefit with a Focus on Pain
- URL: https://www.fdaweb.com/assessing-clinical-benefit-with-a-focus-on-pain/
- Published: 2020-08-13T12:00:00.000Z
- Updated: 2026-09-14T16:24:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147424

CDER researchers say that although pain intensity has been the primary outcome measure in clinical trials for pain, an array of measures assessing clinical outcomes from multiple perspectives can allow for a more comprehensive interpretation of how a treatment affects patients’ lives. Writing in *Neurotherapeutics*, the researchers [say](https://link.springer.com/article/10.1007/s13311-020-00906-6?ref=fdaweb.com) that careful consideration should be given to how pain affects the feeling and functioning of each distinct patient population and which outcome assessment or combination of assessments may be necessary to provide a more comprehensive view of the patient experience.

“The early stages of medical product development are an important opportunity to engage with regulatory agencies to discuss potential approaches to clinical trial design and outcome measurement strategies,” the researchers write.