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http://hdl.handle.net/1942/32474
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DC Field | Value | Language |
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dc.contributor.author | BUYSE, Marc | - |
dc.contributor.author | Trotta, Laura | - |
dc.contributor.author | Saad, Everardo D. | - |
dc.contributor.author | Sakamoto, Junichi | - |
dc.date.accessioned | 2020-10-15T10:11:05Z | - |
dc.date.available | 2020-10-15T10:11:05Z | - |
dc.date.issued | 2020 | - |
dc.date.submitted | 2020-09-02T09:54:32Z | - |
dc.identifier.citation | INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 25 (7) , p. 1207 -1214 | - |
dc.identifier.uri | http://hdl.handle.net/1942/32474 | - |
dc.description.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. | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER JAPAN KK | - |
dc.rights | © Japan Society of Clinical Oncology 2020. | - |
dc.subject.other | Investigator-led trials | - |
dc.subject.other | Central statistical monitoring | - |
dc.subject.other | Data quality | - |
dc.subject.other | Trial costs | - |
dc.title | Central statistical monitoring of investigator-led clinical trials in oncology | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 1214 | - |
dc.identifier.issue | 7 | - |
dc.identifier.spage | 1207 | - |
dc.identifier.volume | 25 | - |
local.format.pages | 8 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.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. | - |
dc.description.notes | marc.buyse@iddi.com | - |
dc.description.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 | - |
local.publisher.place | SHIROYAMA TRUST TOWER 5F, 4-3-1 TORANOMON, MINATO-KU, TOKYO, 105-6005, JAPAN | - |
local.type.refereed | Refereed | - |
local.type.specified | Review | - |
dc.identifier.doi | 10.1007/s10147-020-01726-6 | - |
dc.identifier.pmid | 32577951 | - |
dc.identifier.isi | WOS:000542534200001 | - |
dc.contributor.orcid | Buyse, Marc/0000-0002-4559-0994 | - |
local.provider.type | wosris | - |
local.uhasselt.uhpub | yes | - |
local.description.affiliation | [Buyse, Marc] Int Drug Dev Inst IDDI, San Francisco, CA 94133 USA. | - |
local.description.affiliation | [Buyse, Marc] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat I BioSt, Hasselt, Belgium. | - |
local.description.affiliation | [Buyse, Marc; Trotta, Laura] CluePoints, Louvain La Neuve, Belgium. | - |
local.description.affiliation | [Saad, Everardo D.] Int Drug Dev Inst IDDI, 30 Ave Prov, B-1340 Ottignies, Belgium. | - |
local.description.affiliation | [Sakamoto, Junichi] Tokai Cent Hosp, Kakamigahara, Japan. | - |
local.description.affiliation | [Sakamoto, Junichi] Epidemiol & Clin Res Informat Network ECRIN, Kyoto, Japan. | - |
item.contributor | BUYSE, Marc | - |
item.contributor | Trotta, Laura | - |
item.contributor | Saad, Everardo D. | - |
item.contributor | Sakamoto, Junichi | - |
item.validation | ecoom 2021 | - |
item.fulltext | With Fulltext | - |
item.accessRights | Open Access | - |
item.fullcitation | BUYSE, Marc; Trotta, Laura; Saad, Everardo D. & Sakamoto, Junichi (2020) Central statistical monitoring of investigator-led clinical trials in oncology. In: INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 25 (7) , p. 1207 -1214. | - |
crisitem.journal.issn | 1341-9625 | - |
crisitem.journal.eissn | 1437-7772 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
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buyse.pdf | Published version | 843.74 kB | Adobe PDF | View/Open |
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