Biomaterial Database

Missing data in confirmatory clinical trials. 2009

Paul Flyer, and Joseph Hirman

Department of Biostatistics, Pacific Northwest Statistical Consulting, Inc., Woodinville, Washington, USA.

Missing data for key efficacy and safety endpoints in clinical trials have the potential to undermine the scientific integrity of the study and prevent definitive conclusions regarding the safety and efficacy of an experimental product. Much of the missing data is the result of poor protocol design and a lack of agreement in the scientific community regarding the collection of study data after treatment discontinuation instead of an inability to collect the data. Rather than dealing with the fundamental causes of missing data, the statistical community has traditionally attempted to explicitly impute the missing data based upon observed data or more recently through the use of statistical models that implicitly impute the missing data. In this article, the causes for missing data are described and a number of approaches to maintain the integrity of the studies are described.

UI	MeSH Term	Description	Entries
D012107	Research Design	A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.	Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D003625	Data Collection	Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.	Data Collection Methods,Dual Data Collection,Collection Method, Data,Collection Methods, Data,Collection, Data,Collection, Dual Data,Data Collection Method,Method, Data Collection,Methods, Data Collection
D003627	Data Interpretation, Statistical	Application of statistical procedures to analyze specific observed or assumed facts from a particular study.	Data Analysis, Statistical,Data Interpretations, Statistical,Interpretation, Statistical Data,Statistical Data Analysis,Statistical Data Interpretation,Analyses, Statistical Data,Analysis, Statistical Data,Data Analyses, Statistical,Interpretations, Statistical Data,Statistical Data Analyses,Statistical Data Interpretations
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D023381	Endpoint Determination	Establishment of the level of a quantifiable effect indicative of a biologic process. The evaluation is frequently to detect the degree of toxic or therapeutic effect.	Endpoint Assay,End Point Assay,End Point Determination,Assay, End Point,Assay, Endpoint,Assays, End Point,Assays, Endpoint,Determination, Endpoint,Determinations, End Point,Determinations, Endpoint,End Point Assays,End Point Determinations,Endpoint Assays,Endpoint Determinations,Point Assay, End,Point Assays, End,Point Determinations, End

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