> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Study: Orphan Drug Trial Costs are Half of Non-orphan Drugs
- URL: https://www.fdaweb.com/study-orphan-drug-trial-costs-are-half-of-non-orphan-drugs/
- Published: 2019-01-11T12:00:00.000Z
- Updated: 2026-09-15T00:53:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143140

A [new study](https://ojrd.biomedcentral.com/articles/10.1186/s13023-018-0990-4?ref=fdaweb.com) on drug development costs has found that clinical costs per approved orphan drug were half that of a non-orphan drugs. Appearing in the 1/10 issue of the *Orphanet Journal of Rare Diseases*, the study examined the differences in trial characteristics and clinical development costs with 100 orphan and 100 non-orphan drugs.

The University of Toronto researchers said that the orphan drug group had a “higher proportion of Phase 2 trials while the non-orphan group had the highest proportion of trials in Phase 3\. This implies that Phase 2 trials are used as pivotal trials for orphan drugs and some orphan drugs may not even be tested in a Phase 3 setting.”

The researchers acknowledged that more research and discussion are needed to “better align on which cost components should be included in research and development costs for pharmaceuticals.”