Monitoring strategies for clinical intervention studies

Abstract

This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: The main objective of this systematic review of prospective empirical studies is to evaluate the benefits and disadvantages of trial-specific, risk-based monitoring strategies compared with a traditional intensive on-site monitoring strategy or other monitoring strategies for randomized and non-randomized prospective intervention studies.

Impact of monitoring approaches on data quality in clinical trials

“…Many different comparisons have been made between various monitoring strategies and the majority have found that the differences in strategies are noninferior. In the latest study in 2021, Klatte et al published a Cochrane review showing no evidence that any RBM strategy is inferior to extensive monitoring when looking at errors 11 . For a risk‐based approach to be truly risk‐based, the focus must be on risks to the participants, the study outcome and the reliability of data and not just on errors in general.…”

“…In the latest study in 2021, Klatte et al published a Cochrane review showing no evidence that any RBM strategy is inferior to extensive monitoring when looking at errors. 11 For a risk-based approach to be truly risk-based, the focus must be on risks to the participants, the study outcome and the reliability of data and not just on errors in general. The various RBM tools available on the market have different interpretations of risks to a CT, as published by Fneish, who evaluated 18 protocols across six different tools and found variation on the risk categorization between the tools.…”

“…The latter observation is relevant as it indicates that the workload is shifted from on‐site monitor to DM and, depending on the time needed for query resolution, may have a positive or negative impact on the total cost of the study 10 . Together these studies fulfil the updated GCP guidelines, but no large‐scale empirical data comparing a CM with a fully implemented RBM approach have to the knowledge of the authors been published 11 …”

“…10 Together these studies fulfil the updated GCP guidelines, but no large-scale empirical data comparing a CM with a fully implemented RBM approach have to the knowledge of the authors been published. 11 The objective of this paper is to provide a quantification of the impact of monitoring approaches on data quality, more specifically the impact of an RBM approach compared to a CM approach consisting of a combination of full SDV and partial SDV (CM).…”

Source Data Verification (SDV) quality in clinical research: A scoping review

“…Though at reduced levels through risk-based approaches, SDV is still being used as a major strategy to identify errors and assure high-quality data. [26][27][28] This thinking must change. As a fallible manual process, SDV was never capable of assuring high-quality data from a fallible source.…”