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http://hdl.handle.net/1942/20631
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DC Field | Value | Language |
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dc.contributor.author | Timmermans, Catherine | - |
dc.contributor.author | Doffagne, Erik | - |
dc.contributor.author | Venet, David | - |
dc.contributor.author | Desmet, Lieven | - |
dc.contributor.author | LEGRAND, Catherine | - |
dc.contributor.author | BURZYKOWSKI, Tomasz | - |
dc.contributor.author | BUYSE, Marc | - |
dc.date.accessioned | 2016-02-12T12:43:57Z | - |
dc.date.available | 2016-02-12T12:43:57Z | - |
dc.date.issued | 2016 | - |
dc.identifier.citation | GASTRIC CANCER, 19 (1), p. 24-30 | - |
dc.identifier.issn | 1436-3291 | - |
dc.identifier.uri | http://hdl.handle.net/1942/20631 | - |
dc.description.abstract | Data quality may impact the outcome of clinical trials; hence, there is a need to implement quality control strategies for the data collected. Traditional approaches to quality control have primarily used source data verification during on-site monitoring visits, but these approaches are hugely expensive as well as ineffective. There is growing interest in central statistical monitoring (CSM) as an effective way to ensure data quality and consistency in multicenter clinical trials. CSM with SMART (TM) uses advanced statistical tools that help identify centers with atypical data patterns which might be the sign of an underlying quality issue. This approach was used to assess the quality and consistency of the data collected in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial, involving 1495 patients across 232 centers in Japan. In the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial, very few atypical data patterns were found among the participating centers, and none of these patterns were deemed to be related to a quality issue that could significantly affect the outcome of the trial. CSM can be used to provide a check of the quality of the data from completed multicenter clinical trials before analysis, publication, and submission of the results to regulatory agencies. It can also form the basis of a risk-based monitoring strategy in ongoing multicenter trials. CSM aims at improving data quality in clinical trials while also reducing monitoring costs. | - |
dc.description.sponsorship | The development of SMART (TM) received financial support from the Walloon Government under the BioWin framework (consortium agreement no. 6741). The authors gratefully acknowledge the help of Koji Oba with the interpretation of the statistical signals found in the SAMIT trial. The authors thank the Epidemiological and Clinical Research Information Network at Nagoya University School of Medicine for the preparation of the database of the SAMIT trial. | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER | - |
dc.rights | © The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2015. | - |
dc.subject.other | clinical trials; multicenter study; risk management; quality control; stomach neoplasm | - |
dc.subject.other | Clinical trials; Multicenter study; Risk management; Quality control; Stomach neoplasm | - |
dc.title | Statistical monitoring of data quality and consistency in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 30 | - |
dc.identifier.issue | 1 | - |
dc.identifier.spage | 24 | - |
dc.identifier.volume | 19 | - |
local.format.pages | 7 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | [Timmermans, Catherine; Doffagne, Erik; Buyse, Marc] CluePoints SA, B-1435 Mont St Guibert, Belgium. [Timmermans, Catherine; Desmet, Lieven; Legrand, Catherine] Catholic Univ Louvain, Inst Stat Biostat & Sci Actuarielles, Louvain La Neuve, Belgium. [Venet, David] Univ Brussels, Inst Rech Interdisciplinaires & Dev Intelligence, Brussels, Belgium. [Burzykowski, Tomasz] Int Inst Drug Dev, Louvain La Neuve, Belgium. [Burzykowski, Tomasz; Buyse, Marc] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat, Diepenbeek, Belgium. [Buyse, Marc] Int Inst Drug Dev, Cambridge, MA USA. | - |
local.publisher.place | NEW YORK | - |
local.type.refereed | Refereed | - |
local.type.specified | Review | - |
dc.identifier.doi | 10.1007/s10120-015-0533-9 | - |
dc.identifier.isi | 000367260300006 | - |
item.fulltext | With Fulltext | - |
item.accessRights | Restricted Access | - |
item.fullcitation | Timmermans, Catherine; Doffagne, Erik; Venet, David; Desmet, Lieven; LEGRAND, Catherine; BURZYKOWSKI, Tomasz & BUYSE, Marc (2016) Statistical monitoring of data quality and consistency in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial. In: GASTRIC CANCER, 19 (1), p. 24-30. | - |
item.validation | ecoom 2017 | - |
item.contributor | Timmermans, Catherine | - |
item.contributor | Doffagne, Erik | - |
item.contributor | Venet, David | - |
item.contributor | Desmet, Lieven | - |
item.contributor | LEGRAND, Catherine | - |
item.contributor | BURZYKOWSKI, Tomasz | - |
item.contributor | BUYSE, Marc | - |
crisitem.journal.issn | 1436-3291 | - |
crisitem.journal.eissn | 1436-3305 | - |
Appears in Collections: | Research publications |
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art%3A10.1007%2Fs10120-015-0533-9.pdf Restricted Access | Published version | 539.1 kB | Adobe PDF | View/Open Request a copy |
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