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http://hdl.handle.net/1942/32474
Title: | Central statistical monitoring of investigator-led clinical trials in oncology | Authors: | BUYSE, Marc Trotta, Laura Saad, Everardo D. Sakamoto, Junichi |
Issue Date: | 2020 | Publisher: | SPRINGER JAPAN KK | Source: | INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 25 (7) , p. 1207 -1214 | Abstract: | Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, which are in part due to extensive trial monitoring processes that focus on unimportant details. Risk-based quality management focuses, instead, on "things that really matter". We discuss the role of central statistical monitoring as part of risk-based quality management. We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality. | Notes: | Buyse, M (corresponding author), Int Drug Dev Inst IDDI, San Francisco, CA 94133 USA.; Buyse, M (corresponding author), Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat I BioSt, Hasselt, Belgium.; Buyse, M (corresponding author), CluePoints, Louvain La Neuve, Belgium. marc.buyse@iddi.com |
Other: | Buyse, M (corresponding author), Int Drug Dev Inst IDDI, San Francisco, CA 94133 USA; Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat I BioSt, Hasselt, Belgium; CluePoints, Louvain La Neuve, Belgium. marc.buyse@iddi.com | Keywords: | Investigator-led trials;Central statistical monitoring;Data quality;Trial costs | Document URI: | http://hdl.handle.net/1942/32474 | ISSN: | 1341-9625 | e-ISSN: | 1437-7772 | DOI: | 10.1007/s10147-020-01726-6 | ISI #: | WOS:000542534200001 | Rights: | © Japan Society of Clinical Oncology 2020. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2021 |
Appears in Collections: | Research publications |
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buyse.pdf | Published version | 843.74 kB | Adobe PDF | View/Open |
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