Clinical trial simulation of antiviral drugs
assays. Finally, models that do not consider drug mechanisms lead to incorrect efficacy estimates. Data-validated CTS is increasingly used to inform drug dose and dosing interval, treatment timing and duration, virologic endpoint selection, and sample size, particularly when applied to detailed phase 1 and 2 trial data. Given the high expense of antiviral licensure trials, CTS models are vital to optimize trial efficacy and de-risk the drug development process.
Authors
- Ugo Avila-Ponce de León (ORCID: https://orcid.org/0000-0002-8463-5091)
- Elizabeth R. Duke (ORCID: https://orcid.org/0000-0002-3348-9039)
- Bryan T. Mayer (ORCID: https://orcid.org/0000-0003-2258-5276)
- Lucero Rodriguez Rodriguez (ORCID: https://orcid.org/0000-0003-1842-1252)
- Joshua T. Schiffer (ORCID: https://orcid.org/0000-0002-2598-1621)
- Daniel B. Reeves (ORCID: https://orcid.org/0000-0001-5684-9538)
- Beatrix Haddock
- Katherine Owens
- Shingo Iwami
- Shadi Esmaeili-Wellman
Institutions
- Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa (ZA)
- University of California, San Francisco (US)
- University of Washington (US)
- VA Palo Alto Health Care System (US)
- Fred Hutch Cancer Center (US)
- Nagoya University (JP)
Publication Details
- Journal
- Journal of Virology
- Published
- 2026-04-17
- DOI
- https://doi.org/10.1128/jvi.01814-24
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institute of Allergy and Infectious Diseases