A proposed charter for clinical trial data monitoring committees: helping them to do their job well.
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| Title: | A proposed charter for clinical trial data monitoring committees: helping them to do their job well. |
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| Authors: | DAMOCLES (DAta MOnitoring Committees: Lessons, Ethics, Statistics) Study Group (CORPORATE AUTHOR), DAMOCLES Study Group, NHS Health Technology Assessment Programme (CORPORATE AUTHOR) |
| Source: | Lancet. 2/19/2005, Vol. 365 Issue 9460, p711-722. 12p. |
| Abstract: | Formal monitoring of data from randomised controlled trials (RCTs) is becoming more common. Wide variation exists in the structure and organisation of data monitoring committees (DMCs), with little guidance on how they should operate. We used various strategies to consider the behavioural, procedural, and organisational aspects of data monitoring in RCTs: systematic reviews of DMCs and small group processes in decision making; surveys of reports of RCTs, recently completed and ongoing RCTs, and the policies of major organisations connected with RCTs; detailed case studies of four DMCs that faced difficult decisions; and interviews with experienced DMC members. The findings aided the development of a template for a charter for DMCs. We summarise the findings and outline the key considerations at every stage of the data monitoring process. Widespread use of a charter for the structure and organisation of DMCs would promote a systematic and transparent approach, and enable them to operate more effectively and efficiently. [ABSTRACT FROM AUTHOR] |
| Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 106515145 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: A proposed charter for clinical trial data monitoring committees: helping them to do their job well. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22DAMOCLES+%28DAta+MOnitoring+Committees%3A+Lessons%2C+Ethics%2C+Statistics%29+Study+Group%22">DAMOCLES (DAta MOnitoring Committees: Lessons, Ethics, Statistics) Study Group</searchLink> (CORPORATE AUTHOR)<br /><searchLink fieldCode="AR" term="%22DAMOCLES+Study+Group%2C+NHS+Health+Technology+Assessment+Programme%22">DAMOCLES Study Group, NHS Health Technology Assessment Programme</searchLink> (CORPORATE AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 2/19/2005, Vol. 365 Issue 9460, p711-722. 12p. – Name: Abstract Label: Abstract Group: Ab Data: Formal monitoring of data from randomised controlled trials (RCTs) is becoming more common. Wide variation exists in the structure and organisation of data monitoring committees (DMCs), with little guidance on how they should operate. We used various strategies to consider the behavioural, procedural, and organisational aspects of data monitoring in RCTs: systematic reviews of DMCs and small group processes in decision making; surveys of reports of RCTs, recently completed and ongoing RCTs, and the policies of major organisations connected with RCTs; detailed case studies of four DMCs that faced difficult decisions; and interviews with experienced DMC members. The findings aided the development of a template for a charter for DMCs. We summarise the findings and outline the key considerations at every stage of the data monitoring process. Widespread use of a charter for the structure and organisation of DMCs would promote a systematic and transparent approach, and enable them to operate more effectively and efficiently. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/s0140-6736(05)70939-9 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 12 StartPage: 711 Titles: – TitleFull: A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: DAMOCLES (DAta MOnitoring Committees: Lessons, Ethics, Statistics) Study Group – PersonEntity: Name: NameFull: DAMOCLES Study Group, NHS Health Technology Assessment Programme IsPartOfRelationships: – BibEntity: Dates: – D: 19 M: 02 Text: 2/19/2005 Type: published Y: 2005 Identifiers: – Type: issn-print Value: 01406736 Numbering: – Type: volume Value: 365 – Type: issue Value: 9460 Titles: – TitleFull: Lancet Type: main |
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