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# Better Non-efficacy Benefit Communication Needed: Analysis
- URL: https://www.fdaweb.com/better-non-efficacy-benefit-communication-needed-analysis/
- Published: 2019-03-06T12:00:00.000Z
- Updated: 2026-09-15T01:10:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143540

University researchers who analyzed 20 new molecular entities (NMEs) approved by FDA between 1/2011 and 9/2017 exclusively on non-inferiority pivotal trials say that both drug sponsors and FDA can do a better job of communicating non-efficacy benefits. In a *JAMA Internal Medicine* [Research Letter](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2726045?ref=fdaweb.com), the authors say that 75% of sponsor or FDA communications mentioned a non-efficacy benefit, with sponsors mentioning such benefits more often.

FDA’s most frequently cited benefit was “new treatment option,” the report says, adding that “all NMEs are by definition new treatment options. Novelty alone carries no intrinsic therapeutic value, is known before initiation of studies, and neither explains benefits for patients of new interventions nor justifies harms to participants enrolled in trials.”

The researchers say that future noninferiority trials should present potential non-efficacy benefits in protocols and consent forms. “Potential non-efficacy benefits that can be formally studied, such as decreased adverse effects, should be required by regulators to be evaluated in trials and clearly communicated in study results,” they conclude.