Central statistical monitoring in clinical trial management: A scoping review.

BACKGROUND

Clinical trials handle a huge amount of data which can be used during the trial to improve the ongoing study conduct. It is suggested by regulators to implement the remote approach to evaluate clinical trials by analysing collected data. Central statistical monitoring helps to achieve that by employing quantitative methods, the results of which are a basis for decision-making on quality issues.

METHODS

This article presents a scoping review which is based on a systematic and iterative approach to identify and synthesise literature on central statistical monitoring methodology. In particular, we investigated the decision-making processes (with emphasis on quality issues) of central statistical monitoring methodology and its place in the clinical trial workflow. We reviewed papers published over the last 10 years in two databases (Scopus and Web of Science) with a focus on data mining algorithms of central statistical monitoring and its benefit to the quality of trials.

RESULTS

As a result, 24 scientific papers were selected for this review, and they consider central statistical monitoring at two levels. First, the perspective of the central statistical monitoring process and its location in the study conduct in terms of quality issues. Second, central statistical monitoring methods categorised into practices applied in the industry, and innovative methods in development. The established methods are discussed through the prism of categories of their usage. In turn, the innovations refer to either research on new methods or extensions to existing ones.

DISCUSSION

Our review suggests directions for further research into central statistical monitoring methodology - including increased application of multivariate analysis and using advanced distance metrics - and guidance on how central statistical monitoring operates in response to regulators' requirements.