Show simple item record

dc.creatorGrant, A.M.en
dc.creatorAltman, D.G.en
dc.creatorBabiker, A.G.en
dc.creatorCampbell, M.K.en
dc.creatorClemens, F.en
dc.creatorDarbyshire, J.H.en
dc.creatorElbourne, D.R.en
dc.creatorMcLeer, S.K.en
dc.creatorParmar, M.K.B.en
dc.creatorPocock, S.J.en
dc.creatorSpiegelhalter, D.J.en
dc.creatorSydes, M.R.en
dc.creatorWalker, A.E.en
dc.creatorWallace, S.A.en
dc.date.accessioned2016-01-08T23:45:55Zen
dc.date.available2016-01-08T23:45:55Zen
dc.date.created2005-02-19en
dc.date.issued2005-02-19en
dc.identifier.bibliographicCitationLancet 2005 February 19-25; 365(9460): 711-722en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=A+proposed+charter+for+clinical+trial+data+monitoring+committees:+helping+them+to+do+their+job+well&title=Lancet+&volume=365&issue=9460&spage=711-722&date=2005-02&au=Grant,+A.M.;+Altman,+D.G.;+Babiker,+A.G.;+Campbell,+M.K.;+Clemens,+F.;+Darbyshire,+J.H.;+Elbourne,+D.R.;+McLeer,+S.K.;+Parmar,+M.K.B.;+Pocock,+S.J.;+Spiegelhalter,+D.J.;+Sydes,+M.R.;+Walker,+A.E.;+Wallace,+S.A.en
dc.identifier.urihttp://hdl.handle.net/10822/983450en
dc.description.abstractFormal 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.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:282468en
dc.subjectCase Studiesen
dc.subjectData Monitoring Committeesen
dc.subjectDecision Makingen
dc.subjectInterviewsen
dc.subjectSurveysen
dc.subject.classificationCodes of / Position Statements on Professional Ethicsen
dc.subject.classificationHuman Experimentation Policy Guidelines / Institutional Review Boardsen
dc.subject.classificationSocial Control of Human Experimentationen
dc.titleA Proposed Charter for Clinical Trial Data Monitoring Committees: Helping Them to Do Their Job Wellen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


This item appears in the following Collection(s)

Show simple item record


Georgetown University Seal
©2009—2018 Bioethics Research Library
Box 571212 Washington DC 20057-1212
202.687.3885