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Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

dc.contributor.author Rockhold, FW
dc.contributor.author Enas, GG
dc.coverage.spatial England
dc.date.accessioned 2015-12-03T17:46:35Z
dc.date.issued 1993-03
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/8493425
dc.identifier.issn 0277-6715
dc.identifier.uri https://hdl.handle.net/10161/11024
dc.description.abstract 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.
dc.language eng
dc.publisher Wiley
dc.relation.ispartof Stat Med
dc.subject Biomedical and Behavioral Research
dc.subject Empirical Approach
dc.subject Clinical Trials Data Monitoring Committees
dc.subject Clinical Trials as Topic
dc.subject Drug Industry
dc.subject Ethics
dc.subject Government Regulation
dc.subject Humans
dc.subject Internationality
dc.subject Research Design
dc.subject Research Subjects
dc.subject Risk Assessment
dc.subject United States
dc.subject United States Food and Drug Administration
dc.title Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
dc.type Journal article
duke.contributor.id Rockhold, FW|0668002
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/8493425
pubs.begin-page 471
pubs.end-page 479
pubs.issue 5-6
pubs.organisational-group Basic Science Departments
pubs.organisational-group Biostatistics & Bioinformatics
pubs.organisational-group Duke
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group School of Medicine
pubs.publication-status Published
pubs.volume 12
duke.contributor.orcid Rockhold, FW|0000-0003-3732-4765


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