Feasibility of a Hybrid Risk-Adapted Monitoring System in Investigator-Sponsored Trials in Cancer
- 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 high-risk 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 < 0.0001), and showed comparable results in revealing major issues such as investigational product compliance and delayed reporting of serious adverse events (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 multi-center oncology investigator-sponsored trials.
- 김신애; 김윤옥; 김윤정; 김태원; 이지성; 임준서; 홍영란
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- Drug Safety and Pharmacovigilance; Medicine; Original Research; Pharmacotherapy; Pharmacy
- THERAPEUTIC INNOVATION & REGULATORY SCIENCE
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