Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
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The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in industry trials due to the regulatory requirements and the need to more thoroughly evaluate safety of new compounds. As part of this process, interim analyses are employed to make decisions about treatment effects. In some cases, such analyses may require the use of an external data monitoring committee to assist in the data review, analysis and decision making. A number of examples of interim analyses, with and without data monitoring committees, are discussed. Issues surrounding the need for external data monitoring committees and recommendations are presented. In particular the issues of sponsor participation in the data monitoring committee and controls of the decision making process are considered.
SubjectBiomedical and Behavioral Research
Clinical Trials Data Monitoring Committees
Clinical Trials as Topic
United States Food and Drug Administration
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Professor of Biostatistics & Bioinformatics
Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. In addition his role of full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute, Frank is also Managing Partner of HunterRock