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Monitoring randomized clinical trials in Africa; pragmatic approaches and experiences from HIV trials

Thomason, MJ; Spyer, MJ; Joffe, N; Boles, J; Burke, A; Wilkes, HC; Rauchenberger, M; (2015) Monitoring randomized clinical trials in Africa; pragmatic approaches and experiences from HIV trials. Clinical Investigation , 5 (6) pp. 585-597. 10.4155/cli.15.18. Green open access

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Abstract

he Medical Research Council Clinical Trials Unit has coordinated HIV clinical trials in Africa for almost 15 years. Approaches to monitoring trial data have been developed using a combination of on-site and central (database) monitoring. Tools and templates have been designed to supplement trial protocols and help standardize trial processes. Local monitors supplement infrequent visits from the sponsor, enabling monitoring at the required intensity and allowing for capacity building. Database strategies have evolved to complement on-site visits, allowing more effective monitoring of data quality, and providing functionality in a cost-effective manner. Ongoing training and support of monitors and site staff is given via teleconferences, emails and meetings. Mentoring of site staff by monitors is encouraged, including cross-site visits where resources allow.

Type: Article
Title: Monitoring randomized clinical trials in Africa; pragmatic approaches and experiences from HIV trials
Open access status: An open access version is available from UCL Discovery
DOI: 10.4155/cli.15.18
Publisher version: http://dx.doi.org/10.4155/cli.15.18
Language: English
Additional information: © 2015 Future Science Ltd
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Population, Policy and Practice Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1470477
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