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Feasibility of a Hybrid Risk-Adapted Monitoring System in Investigator-Sponsored Trials in Cancer

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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 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.
Author(s)
김신애김윤옥김윤정김태원이지성임준서홍영란
Issued Date
2021
Type
Article
Keyword
Drug Safety and PharmacovigilanceMedicineOriginal ResearchPharmacotherapyPharmacy
DOI
10.1007/s43441-020-00204-5
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7820
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2435191719&amp;context=PC&amp;vid=ULSAN&amp;lang=ko_KR&amp;search_scope=default_scope&amp;adaptor=primo_central_multiple_fe&amp;tab=default_tab&amp;query=any,contains,Feasibility%20of%20a%20Hybrid%20Risk-Adapted%20Monitoring%20System%20in%20Investigator-Sponsored%20Trials%20in%20Cancer&amp;offset=0&amp;pcAvailability=true
Publisher
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
Location
스위스
Language
영어
ISSN
2168-4790
Citation Volume
55
Citation Number
1
Citation Start Page
180
Citation End Page
189
Appears in Collections:
Medicine > Medicine
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