Augmenting Insufficiently Accruing Oncology Clinical Trials Using Generative Models: Validation Study
For an oncology study with insufficient accrual with as few as 60% of target recruitment, sequential synthesis can enable the simulation of the full dataset had the study continued accruing patients and can be an alternative to drawing conclusions from an underpowered study. These results provide evidence demonstrating the potential for generative models to rescue poorly accruing clinical trials, but additional studies are needed to confirm these findings and to generalize them for other diseases.
Authors
- Lois E. Shepherd (ORCID: https://orcid.org/0000-0002-5035-1621)
- Dominik Hlauschek (ORCID: https://orcid.org/0009-0009-1009-3777)
- Dhenuka Radhakrishnan (ORCID: https://orcid.org/0000-0002-8637-1480)
- Lucy Mosquera (ORCID: https://orcid.org/0000-0002-5289-8372)
- Alexander Paterson (ORCID: https://orcid.org/0000-0002-3138-3337)
- Julie R. Gralow (ORCID: https://orcid.org/0000-0003-3837-9928)
- Michael Gnant (ORCID: https://orcid.org/0000-0003-1002-2118)
- Nicholas Mitsakakis (ORCID: https://orcid.org/0000-0001-9041-9152)
- Bingshu E. Chen
- Christian Fesl (ORCID: https://orcid.org/0000-0001-5631-076X)
- Richard Greil (ORCID: https://orcid.org/0000-0002-4462-3694)
- Gregory R. Pond (ORCID: https://orcid.org/0000-0003-1033-0882)
- Elizabeth Jonker
- Lisa Vandermeer (ORCID: https://orcid.org/0000-0001-5921-1441)
- Ana-Alicia Beltran-Bless (ORCID: https://orcid.org/0000-0003-4880-8167)
- Samer El Kababji (ORCID: https://orcid.org/0000-0002-7642-2280)
- Khaled El Emam (ORCID: https://orcid.org/0000-0003-3325-4149)
- Marie-France Savard (ORCID: https://orcid.org/0000-0002-7651-0870)
- William E. Barlow (ORCID: https://orcid.org/0000-0003-4651-2282)
- Gabriel Rinnerthaler (ORCID: https://orcid.org/0000-0001-7438-1465)
- Marija Balić (ORCID: https://orcid.org/0000-0001-9482-9191)
- Mark Clemons (ORCID: https://orcid.org/0000-0002-0738-2713)
Institutions
- Alberta Health Services (CA)
- Statistics Austria (AT)
- University of Ottawa (CA)
- University of Washington (US)
- Medical University of Graz (AT)
- Queen's University (CA)
- Paracelsus Medical University (AT)
- Agricultural Research Institute of Ontario (CA)
- University of Washington Medical Center (US)
- Comprehensive Cancer Center Vienna (AT)
- Austrian Breast & Colorectal Cancer Study Group (AT)
- Medical University of Vienna (AT)
- McMaster University (CA)
Publication Details
- Journal
- Journal of Medical Internet Research
- Published
- 2025-03-05
- DOI
- https://doi.org/10.2196/66821
- Citations
- 9
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 28.18