This statistic displays the median number of required patients for orphan and non-orphan products in phase III trial as of 2015. There is a median number of 538 patients needed for orphan drug phase III trials. Orphan drugs are used to target rare diseases or disorders, which in the United States is defined as less than 200,000 patients. The development of orphan drugs are currently incentivized in the United States through the Orphan Drug Act of 1983.
Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015*
Profit from the additional features of your individual account
Currently, you are using a shared account. To use individual functions (e.g., mark statistics as favourites, set
statistic alerts) please log in with your personal account.
If you are an admin, please authenticate by logging in again.
Learn more about how Statista can support your business.
Evaluate. (October 30, 2015). Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015* [Graph]. In Statista. Retrieved December 22, 2024, from https://www.statista.com/statistics/373389/phase-iii-trial-sizes-orphan-and-non-orphan-drugs/
Evaluate. "Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015*." Chart. October 30, 2015. Statista. Accessed December 22, 2024. https://www.statista.com/statistics/373389/phase-iii-trial-sizes-orphan-and-non-orphan-drugs/
Evaluate. (2015). Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015*. Statista. Statista Inc.. Accessed: December 22, 2024. https://www.statista.com/statistics/373389/phase-iii-trial-sizes-orphan-and-non-orphan-drugs/
Evaluate. "Required Number of Patients for Phase Iii Trials of Orphan and Non-orphan Drugs as of 2015*." Statista, Statista Inc., 30 Oct 2015, https://www.statista.com/statistics/373389/phase-iii-trial-sizes-orphan-and-non-orphan-drugs/
Evaluate, Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015* Statista, https://www.statista.com/statistics/373389/phase-iii-trial-sizes-orphan-and-non-orphan-drugs/ (last visited December 22, 2024)
Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015* [Graph], Evaluate, October 30, 2015. [Online]. Available: https://www.statista.com/statistics/373389/phase-iii-trial-sizes-orphan-and-non-orphan-drugs/
