Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials

Sydes, Matthew R.; Spiegelhalter, David; Altman, Douglas G.; Babiker, Abdel; Parmar, Mahesh

doi:10.1191/1740774504cn004rr

Cited by 64 publications

(73 citation statements)

References 83 publications

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“…146 In the UK, public funders of research, including the HTA programme and the Medical Research Council, require independent monitoring committees to be established for all RCTs, 147,148 although the approach employed in the UK may not be the model used elsewhere. 149 In RCTs of effects of interventions, an independent trial steering committee (TSC) oversees the management and financial aspects of the study, and a data monitoring committee (DMC) (also sometimes known as a data monitoring and ethics committee or a data monitoring and safety board) oversees the accumulating data.…”

Section: Preamblementioning

confidence: 99%

Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

Daniels

Gray²,

Pattison³

et al. 2009

Health Technol Assess

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How to obtain copies of this and other HTA programme reports An electronic version of this publication, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable CD-ROM is also available (see below).Printed copies of HTA monographs cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our Despatch Agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK. We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment programmeT he Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in t...

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Section: Preamblementioning

confidence: 99%

Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

Daniels

Gray²,

Pattison³

et al. 2009

Health Technol Assess

View full text Add to dashboard Cite

show abstract

“…Toward this end, the use of independent Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of a trial and participant safety has increased substantially [1,2]. In fact, in an effort to improve the quality of clinical research and ensure the protection of human subjects, the National Institutes of Health (NIH) has issued guidelines and regulations to increase the use of data and safety monitoring within clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Data and safety monitoring in social behavioral intervention trials: the REACH II experience

et al. 2006

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Background-Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials.

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“…Der publizierte Vorschlag für eine Charta umfasst insgesamt 10 Unterpunkte, die präzise vom Sponsor beschrieben werden sollen [9]. Neben einem berichteten Anstieg von DMCs in randomisierten, kontrollierten klinischen Prüfungen über das letzte Jahrzehnt konnten Regressionsmodelle in der Auswertung der Literatur angewandte Kriterien für einen Einsatz von DMCs aufzeigen: Mortalitätsend-punkte, multizentrische klinische Prü-fungen, Anzahl der Prüfungsteilnehmer und Placebokontrolle [10,11].…”

Section: Data Monitoring Committees Third Pillar In the Methodical Cunclassified

Das Data Monitoring Committee

Fischer

2008

Bundesgesundheitsbl.

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Data Monitoring Committees (DMC) are increasingly becoming integrated into the methodical procedure of clinical trials, in order to support sponsors in their central role. Whereas monitors and auditors, respectively, give quality assuring recommendations in compliance with GCP, an implemented DMC is able to give sponsors far-reaching recommendations owing to its access to unblinded data. Besides the main intention of enhancing safety during the conduction of clinical trials, the premature termination of clinical trials due to insufficient efficacy of the investigational medicinal product may be a result. Based on the European Guideline EMEA/CHMP/EWP/5872/03 Corr and based on published literature, criteria and crucial aspects for implementing this independent committee are being named If, in the course of a clinical trial, the implemented DMC notices an alteration in the risk-benefit assessment in the context of pharmacovigilance, immediate notification obligations of the Sponsor to the higher federal authorities and to the ethics committees arise.

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Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials

Cited by 64 publications

References 83 publications

Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

Data and safety monitoring in social behavioral intervention trials: the REACH II experience

Das Data Monitoring Committee

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