Abstract
With the emergence of new technologies for data collection, the continued impact of the COVID-19 pandemic, and the increasing number of partially or fully decentralized clinical trials (DCTs), the importance of risk-based monitoring (RBM) and the larger risk-based quality management (RBQM) framework in clinical trial management is increasing. RBM and RBQM focus on the detection of events or trends that impact trial quality in terms of participant safety and data integrity. In 2019, the Association of Clinical Research Organizations (ACRO) began a landscape survey of RBM/RBQM implementation in ongoing clinical trials. Initial results of this survey, representing full-year data for 2019, were reported previously. Here, we present full-year landscape data for 2020 drawn from 5,987 clinical trials ongoing at the end of 2020, including 908 new studies started that year. Of these trials, 77% implemented at least one RBM/RBQM component, an increase from 47% for studies ongoing at the end of 2019. We also observed increased implementation for three of the five RBM components included in the survey. Centralized monitoring decreased nominally in 2020 compared with 2019. Although the percentages of 2020 trials incorporating reduced source data verification (SDV) and reduced source data review (SDR) increased from 2019 to 2020, these numbers are still low considering the large percentage of trials implementing at least one RBQM component. In the current clinical trial landscape, as more DCTs are launched and new data collection technologies are implemented, there remains a pressing need for greater use of centralized monitoring coupled with reductions in SDR/SDV and, ultimately, greater adoption of RBM and RBQM.
Highlights
Risk-based monitoring (RBM) in clinical trials focuses on detecting, addressing, preventing, and mitigating risks that could compromise critical trial processes, patient safety, or data integrity
This more efficient approach to trial monitoring is an integral part of the risk-based quality management (RBQM) framework, described by the European Medicines Agency (EMA) in 2013 as “a systematic process put in place to identify, assess, control, communicate and review the risks associated with the clinical trial during its lifecycle.” [1]
We explore the implications of our findings for clinical trial management post-pandemic based on our experience with RBM and RBQM implementation
Summary
Risk-based monitoring (RBM) in clinical trials focuses on detecting, addressing, preventing, and mitigating risks that could compromise critical trial processes, patient safety, or data integrity. This more efficient approach to trial monitoring is an integral part of the risk-based quality management (RBQM) framework, described by the European Medicines Agency (EMA) in 2013 as “a systematic process put in place to identify, assess, control, communicate and review the risks associated with the clinical trial during its lifecycle.” [1]. We previously reported results from ACRO’s landscape survey on the implementation of RBM/RBQM components across 6513 clinical trials ongoing at the end of 2019, as well as additional data on trial execution during the first half of 2020, at the onset of the COVID-19 global pandemic [3]
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