A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

Author:

Fernandes Ricardo M,van der Lee Johanna H,Offringa Martin

Publisher

Springer Science and Business Media LLC

Subject

Pediatrics, Perinatology and Child Health

Reference155 articles.

1. Ellenberg S, Fleming T, DeMets D: Data Monitoring Committees in Clinical Trials. 2002, Chichester: John Wiley & Sons, Ltd, 10.1002/0470854162.

2. Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, et al: Issues in data monitoring and interim analysis of trials. Health Technol Assess. 2005, 9: 1-iv.

3. DAMOCLES Study Group: A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005, 365: 711-722.

4. European Medicines Agency (Committee for Medicinal Products for Human Use): Guideline on Data Monitoring Committees. 2005, [ http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf ]

5. Food and Drug Administration: Establishment and Operation of Clinical Trial Data Monitoring Committees. 2006, [ http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf ]

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