Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers
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rare cancers, is dependent upon clinical trials; however, as many as 32% of rare-disease trials go uncompleted or unpublished due to insufficient accrual.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 s...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-08-01
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| Series: | Clinics and Practice |
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| Online Access: | https://www.mdpi.com/2039-7283/12/5/72 |
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| author | Zachary T. Elliott Zachary Goldberg Ramez Philips Jennifer M. Johnson Margaret T. Kasner William K. Kelly Sarah Osipowicz Rachael Dampman Joseph M. Curry |
| author_facet | Zachary T. Elliott Zachary Goldberg Ramez Philips Jennifer M. Johnson Margaret T. Kasner William K. Kelly Sarah Osipowicz Rachael Dampman Joseph M. Curry |
| author_sort | Zachary T. Elliott |
| collection | DOAJ |
| description | 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rare cancers, is dependent upon clinical trials; however, as many as 32% of rare-disease trials go uncompleted or unpublished due to insufficient accrual.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 (<i>n</i> = 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. |
| first_indexed | 2024-03-09T20:26:24Z |
| format | Article |
| id | doaj.art-a054b194539e432596ee7306284b1d2e |
| institution | Directory Open Access Journal |
| issn | 2039-7283 |
| language | English |
| last_indexed | 2024-03-09T20:26:24Z |
| publishDate | 2022-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Clinics and Practice |
| spelling | doaj.art-a054b194539e432596ee7306284b1d2e2023-11-23T23:34:54ZengMDPI AGClinics and Practice2039-72832022-08-0112569270010.3390/clinpract12050072Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer CentersZachary T. Elliott0Zachary Goldberg1Ramez Philips2Jennifer M. Johnson3Margaret T. Kasner4William K. Kelly5Sarah Osipowicz6Rachael Dampman7Joseph M. Curry8Department of Otolaryngology–Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA 19144, USADepartment of Otolaryngology–Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA 19144, USADepartment of Otolaryngology–Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA 19144, USADepartment of Medical Oncology, Philadelphia, Thomas Jefferson University, Philadelphia, PA 19144, USADepartment of Medical Oncology, Philadelphia, Thomas Jefferson University, Philadelphia, PA 19144, USADepartment of Medical Oncology, Philadelphia, Thomas Jefferson University, Philadelphia, PA 19144, USASidney Kimmel Cancer Center Protocol Review Committee, Thomas Jefferson University, Philadelphia, PA 19144, USASidney Kimmel Cancer Center Protocol Review Committee, Thomas Jefferson University, Philadelphia, PA 19144, USADepartment of Otolaryngology–Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA 19144, USAProgress 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 (<i>n</i> = 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.https://www.mdpi.com/2039-7283/12/5/72rare diseasesclinical trialsaccrual and monitoring |
| spellingShingle | Zachary T. Elliott Zachary Goldberg Ramez Philips Jennifer M. Johnson Margaret T. Kasner William K. Kelly Sarah Osipowicz Rachael Dampman Joseph M. Curry Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers Clinics and Practice rare diseases clinical trials accrual and monitoring |
| title | Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers |
| title_full | Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers |
| title_fullStr | Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers |
| title_full_unstemmed | Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers |
| title_short | Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers |
| title_sort | accrual monitoring practices for various disease trials among aaci member cancer centers |
| topic | rare diseases clinical trials accrual and monitoring |
| url | https://www.mdpi.com/2039-7283/12/5/72 |
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