Feasibility of a Hybrid Risk-Adapted Monitoring System in Investigator-Sponsored Trials in Cancer
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ORIGINAL RESEARCH
Feasibility of a Hybrid Risk‑Adapted Monitoring System in Investigator‑Sponsored Trials in Cancer Sinae Kim, RN1 · YunJung Kim, RN1 · YoungLan Hong, MSN1 · YunOk Kim, PhD1 · Joon Seo Lim, PhD2 · JiSung Lee, PhD3 · Tae Won Kim, MD, PhD1,4 Received: 17 March 2020 / Accepted: 7 August 2020 © The Drug Information Association, Inc 2020
Abstract Background We assessed the feasibility of a hybrid monitoring system (minimal on-site monitoring + strategic central monitoring) used at the academic research office at Asan Medical Center (Seoul, Korea) in monitoring investigator-sponsored oncology trials. Methods Monitoring findings in three oncology trials conducted between 2014 and 2017 were compared. A confirmatory source data verification (SDV) was carried out in the low-risk trial and compared with the central monitoring findings. The economic advantages of central monitoring were tested by calculating the monitoring hours per patient. Results A total of 50, 118, 228 patients were enrolled in the high-, intermediate-, and low-risk trials, respectively. The highrisk trial was monitored through 42 on-site visits (1299 findings); the intermediate-risk trial had 79 monitorings (on-site, 24%; central, 76%; 1464 findings); the low-risk trial had 197 monitorings (on-site, 4%; central, 96%; 3364 findings). Central monitoring was more effective than on-site monitoring in revealing minor errors such as “missing case report forms” and “data outliers” (both P 0.05). Confirmatory SDV in the low-risk trial revealed more findings than central monitoring in the “inconsistent data” and “inappropriate adverse event” categories. The total monitoring hours per patient were lower in the intermediate- and low-risk trials than in the high-risk trial (8.1 and 7.3 vs. 14.3 h, respectively). Conclusion Our hybrid monitoring system showed acceptable feasibility in revealing both major and minor issues in multicenter oncology investigator-sponsored trials. Keywords Academic research office · Central monitoring · Clinical trial · Investigator-sponsored trial · Risk-adapted monitoring · Risk-based monitoring
Introduction Sinae Kim, YunJung Kim, YoungLan Hong, and Joon Seo Lim contributed equally to this project as co-first authors. * Tae Won Kim [email protected] 1
Clinical Trial Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2
Scientific Publications Team, Clinical Research Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
3
Clinical Research Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
4
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic‑ro 43‑gil, Songpa‑gu, Seoul 05505, Korea
Effective monitoring of clinical investigations is critical for ensuring adequate protection of human subjects and conducting high-quality studies [1]. However, modern multimodality clinical trials, especially those in oncology, are considerably complex and pose a substantial lo
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