Characterization of terminated and withdrawn clinical trials for the treatment and prevention of oral mucositis
Contrary to general CTs where safety/efficacy concerns predominate, our results suggest OM-related trial failures are associated with a broader list of challenges including recruitment/enrollment, funding/sponsorship, and investigator/site issues. OM CTs demand aggressive planning, funding, and careful selection of trial sites and sponsorship to assure timely subject recruitment and reduce the risk for early termination and withdrawal.
Authors
- Alex S. Reznik (ORCID: https://orcid.org/0000-0001-8993-8617)
- Stephen T. Sonis (ORCID: https://orcid.org/0000-0001-6480-2625)
- Alessandro Villa (ORCID: https://orcid.org/0000-0002-1966-6000)
Institutions
- Brigham and Women's Hospital (US)
- Baptist Hospital of Miami (US)
- Harvard University (US)
- University of Miami (US)
- University of California, San Francisco (US)
- Baptist Health South Florida (US)
- Dana-Farber Cancer Institute (US)
- Dana-Farber Brigham Cancer Center (US)
- PDF Solutions (United States) (US)
Publication Details
- Journal
- Journal of Clinical and Translational Science
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1017/cts.2025.65
- Citations
- 2
- Primary Topic
- Oral health in cancer treatment
- Type
- article
- Field-Weighted Citation Impact
- 3.04
Funders
- University of Cambridge
- National Institutes of Health