Document Type
Article
Publication Date
8-31-2022
Abstract
Progress in the management of rare diseases, including rare cancers, is dependent upon clinical trials; however, as many as 32% of rare-disease trials go uncompleted or unpublished due to insufficient accrual. Monitoring practices may differ between institutions. We sought to survey the regulatory standards for various trial types among major U.S. cancer centers. A 10-question survey was designed using Qualtrics assessment software. The survey was sent via email to an internal server of member institutions of the Association of American Cancer Institutes (AACI). Of 103 AACI centers, 31% completed the survey (n = 32). Respondents differed in their definitions of a rare disease, minimum expectations for rare tumor studies, and frequency of accrual monitoring by their institutional Protocol Review and Monitoring Committee. Seventy-three percent of respondents did not close trials based on low accrual. Strategies to optimize accrual included investigator incentives for high accrual and penalties for low accrual in 37% and 13% of respondents, respectively.
Recommended Citation
Elliott, Zachary T; Goldberg, Zachary N.; Philips, Ramez; Johnson, Jennifer; Kasner, Margaret; Kelly, William Kevin; Osipowicz, Sarah; Dampman, Rachael; and Curry, Joseph, "Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers" (2022). Department of Otolaryngology - Head and Neck Surgery Faculty Papers. Paper 66.
https://jdc.jefferson.edu/otofp/66
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
36136866
Language
English
Comments
This article is the authors' final version prior to publication in Clinics and Practice, Volume 12, Issue 5, August 2022, Pages 692 - 700.
The published version is available at https://doi.org/10.3390/clinpract12050072. Copyright © Elliott et al.