The Prevention and Treatment of Missing Data in Clinical Trials (2010) / Chapter Skim
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Pages 1-6
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Food and Drug Administration (FDA) to prepare "a report with recommendations that would be useful for FDA's development of a 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." The panel's work focused primarily on Phase III confirmatory clinical trials that are the basis for the approval of drugs and devices.
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analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations here, in the body of the report the panel offers additional recommendations on the conduct of clinical trials and techniques for analysis of trial data.
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The techniques we suggest to limit the amount of missing data include • choices of study sites, investigators, participants, study outcomes, time in study and times of measurement, and the nature and frequency of follow-up to limit the amount of missing data; • the use of rescue therapies or alternative treatment regimens, to allow meaningful analysis of individuals who discontinue the assigned treatment; • limiting participant burden in other ways, such as making followup visits easy in terms of travel and child care; • providing frequent reminders of study visits; • training of investigators on the importance of avoiding missing data;
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Recommendation 9: Statistical methods for handling missing data should be specified by clinical trial sponsors in study protocols, and their associated assumptions stated in a way that can be understood by clinicians. The panel believes that in nearly all cases, there are better alternatives to last observation carried forward and baseline observation carried forward imputation, which are based on more reasonable assumptions and hence result in more reliable inferences about treatment effects.
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and drug, device, and biologic companies that sponsor clinical trials should carry out continued training of their analysts to keep abreast of up-to-date techniques for missing data analysis. FDA should also encourage continued training of their clinical reviewers to make them broadly familiar with missing data terminology and missing data methods.
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sample size calculations in the presence of missing data, (4) design of clinical trials, in particular plans for follow-up after treatment discontinuation (degree of sampling, how many attempts are made, etc.)
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