A common problem in clinical trials is missing data, which occurs when patients do not complete the study and drop out without further measurements. Missing data means that there is usually a bias in the statistical analysis of the more complete or all available data. There is no general way to deal with missing data. We recommend the following: (1) report discontinuation reasons and proportions for each treatment group; (2) conduct sensitivity analyzes to capture different hypothetical scenarios and discuss agreement or differences between them; (3) take care to minimize design (4) collect post-discontinuation data for the primary endpoint where possible; (5) consider the dropout event itself as an important endpoint involving many studies.
In addition to counting all-cause deaths, the missing data in clinical trials are often caused by patients who did not complete the study on schedule and quit the study without further measurement. Possible reasons for patients to withdraw from the study (referred to as “dropouts”) include death, side effects, inconvenience of study procedures, lack of improvement, premature recovery, and other factors that may or may not be related to study procedures and treatments. Missing data could introduce potential bias in the routine statistical analysis of complete or available data. This review attempts to raise awareness of this issue and provide some general guidance for clinical trial practitioners.
- Lwasa Trending
- Sophia Urista
- Monika Laskowska
- Trevor Verga
- Bethan Lloyd Owen
- Valentina Mor Velasquez
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Withdrawal from clinical trials is ubiquitous. The Nuremberg Code, adopted in 1947, lays down the principles of ethical conduct in such processes. These principles require that subjects have the opportunity to withdraw from clinical research at any time. According to these principles, the examiner is obliged to stop the experiment if there is a possibility of harm. I just highlight some insights from recent articles in the field of cardiovascular medicine for illustration.
