Integrating a pilot study and large trial into one adaptive design
The Nutricity study illustrates the potential of seamless phase II/III adaptive designs to improve efficiency in public health research, by integrating pilot and confirmatory phases while preserving scientific integrity. This proposed approach offers a valuable model for future NIH-funded studies adopting innovative trial methodologies.
Authors
- Rebecca Mount (ORCID: https://orcid.org/0000-0003-1769-0784)
- Byron J. Gajewski (ORCID: https://orcid.org/0000-0001-7589-8247)
- Heather Gibbs (ORCID: https://orcid.org/0000-0001-7383-5496)
- Jun Dai (ORCID: https://orcid.org/0000-0001-5155-8838)
- Elena Shergina (ORCID: https://orcid.org/0000-0002-3269-2887)
Institutions
- University of Kansas Medical Center (US)
Publication Details
- Journal
- Contemporary Clinical Trials
- Published
- 2025-10-23
- DOI
- https://doi.org/10.1016/j.cct.2025.108112
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00