title: Conflicts of interest in data monitoring of industry versus publicly financed clinical trials.
abstract: The FDA Guidance, while highly appropriate for industry sponsored trials, need not be imposed on publicly (e.g. NIH) financed clinical trials. While the potential for conflicts of interest exist in the latter, they are in general manageable and pose an acceptable low risk of threatening the integrity of a study. However, the Guidance should heighten the awareness of all investigators in public trials to the potential for the appearance of conflicts and to the need for full and open participation in the management of dualities of interest.
authors.affiliation: The Biostatistics Center, Department of Epidemiology and Biostatistics,The George Washington University, Rockville, MD 20857, USA. jml@biostat.bsc.gwu.edu
authors.forename: John M
authors.initials: JM
authors.lastname: Lachin
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000592:standards; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics* / Q000592:standards; D016265:Conflict of Interest; D003627:Data Interpretation, Statistical; D004345:Drug Industry / Q000191:economics / Q000941:ethics* / Q000592:standards; D004995:Ethics, Professional; D005380:Financing, Government; D017408:Guidelines as Topic; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000941:ethics* / Q000592:standards; D013223:Statistics as Topic / Q000941:ethics*; D014481:United States; D014486:United States Food and Drug Administration / Q000941:ethics* / Q000592:standards