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Project Title:
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Handling Missing Data in Clinical Trials
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PIN:
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CNST-I-08-12-A
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Major Unit:
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Division of Behavioral and Social Sciences and Education
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Sub Unit:
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Committee on National Statistics
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RSO:
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Cohen, Michael
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Subject/Focus Area:
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Project Scope
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The Committee on National Statistics at the request of the U.S. Food and Drug Administration (FDA) will convene a panel of experts in statistical approaches to handling missing data in clinical trials and analyzing results. The panel will use as its main information-gathering resource a workshop that will include participation from multiple stakeholders, including clinical trialists, statistical researchers, appropriate experts from the National Institutes of Health and the pharmaceutical industry, regulators from FDA, and participants in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). From information obtained at the workshop and its deliberations, the panel will prepare a summary of the workshop and a report with recommendations that would be useful for FDA's development of guidance for clinical trials on appropriate study designs and follow-up methods to reduce missing data and appropriate statistical methods to address missing data for analysis of results.
In both the workshop and report, the panel will strive to identify ways in which FDA guidance should be augmented to facilitate the cost-effective use of appropriate methods for missingness by the designers and implementers of clinical trials. Such guidance would usefully distinguish between types of clinical trials and missingness situations. For example, it could be useful to provide guidance on such questions as:
(1)When missingness is likely to result in an appreciable bias such that sophisticated methods for reducing bias would be needed, and, conversely, under what circumstances simple methods such as case deletion could be an acceptable practice.
(2)How to use the leading techniques for variance estimation for each primary estimation method, along with suggestions for implementing these often complex techniques in software packages.
The project is sponsored by the U.S. Department of Health and Human Services, Food and Drug Administration.
The Approximate start date for the project is 9/22/08
A report will be issued at the end of the project in approximately 15 months.
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Project Duration:
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24 months
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Provide FEEDBACK on this project.
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Contact the Public Access Records Office to make an inquiry, request a list of the public access file materials, or obtain a copy of the materials found in the file.
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Tel:
202.334.2000