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Recommendations for the prevention and treatment of incomplete data in clinical assays

Abstract:

Several researches in applied statistics show a broad theoretical development and diversity of perspectives to address the problem of incomplete data in clinical trials. Recent publications show consensus and establish guidelines to mitigate potential biases that causes this problem when data are analyzed. This article will summarize some of the key recommendations to better address the prevention and treatment of incomplete data in clinical trials presented in a report by international experts in 2010 and also referred to the provisions of the regulatory bodies with emphasis on the most recent (2011). There is consensus that the main strategy is to prevent possible incomplete data from the design and conduct of the study. Recommendations are also set to the time of analysis, which basically emphasizes the need of using any available information of all randomized subjects, and implement more sensitive strategies for the inference, that always includes assessing the sensitivity of the results. In 2011 was published a methodological guide-adopted by the European Medicines Agency (EMA)-which provides necessary information from the regulatory perspective to ensure the quality of the results in confirmatory clinical trials. The problem of incomplete data is sometimes unavoidable and should not be ignored, it is necessary to apply appropriate design and analysis strategies. The quality in the presenting results is essential, to avoid biased conclusions and interpretations of the study.