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# Covid Immunomodulatory Clinical Considerations
- URL: https://www.fdaweb.com/covid-immunomodulatory-clinical-considerations/
- Published: 2020-08-12T12:00:00.000Z
- Updated: 2026-09-14T16:24:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147410

CDER researchers say clinical pharmacologists face an unprecedented timeline for Covid-19 drug development, optimizing dose and dosing regimens for repurposed drug products to be evaluated in clinical trials. Writing in the *Journal of Clinical Pharmacology*, the FDAers [summarize](https://accp1.onlinelibrary.wiley.com/doi/abs/10.1002/jcph.1729?af=R&ref=fdaweb.com) the clinical pharmacy considerations in the development of immunomodulatory therapeutic proteins for mitigating the heightened inflammatory response identified in Covid-19.

The article says that while clinical pharmacologists remain focused on dose regimen selection in the traditional randomized controlled trial setting, they also must “embrace the potential advantages of platform trial designs, real-world data analysis, and the potential integration of this knowledge into a new paradigm