Towards Assessing Data Bias in Clinical Trials

Abstract: Algorithms and technologies are essential tools that pervade all aspects of our daily lives. In the last decades, health care research benefited from new computer-based recruiting methods, the use of federated architectures for data storage, the introduction of innovative analyses of datasets, and so on. Nevertheless, health care datasets can still be affected by data bias. Due to data bias, they provide a distorted view of reality, leading to wrong analysis results and, consequently, decisions. For example, in a clinical trial that studied the risk of cardiovascular diseases, predictions were wrong due to the lack of data on ethnic minorities. It is, therefore, of paramount importance for researchers to acknowledge data bias that may be present in the datasets they use, eventually adopt techniques to mitigate them and control if and how analyses results are impacted. This paper proposes a method to address bias in datasets that: (i) defines the types of data bias that may be present in the dataset, (ii) characterizes and quantifies data bias with adequate metrics, (iii) provides guidelines to identify, measure, and mitigate data bias for different data sources. The method we propose is applicable both for prospective and retrospective clinical trials. We evaluate our proposal both through theoretical considerations and through interviews with researchers in the health care environment.