With the development and expansion of the clinical research sector, problems related to it have also emerged. Dependency on traditional trial methods of on-site monitoring and 100% source data verification are no longer considered convenient and cost effective option. Hence, the US Food and Drug Administration (FDA) has suggested an alternative method known as Risk-based Monitoring.
Risk-based Monitoring (RBM) is a clinical monitoring approach where the risks in clinical trials are identified, investigated, analyzed and mitigated taking the quality and safety of the research into consideration. RBM mainly focuses on centralized and targeted monitoring with centralized data collection as opposed to the standard process of manual on-site evaluation and data assembly. The traditional method consists of in-person site observation which becomes cumbersome due to its limitations in assessment, a large study population of patients as well as the allocation of funds. In this case, RBM acts as a paradigm shift in clinical research sphere as it is a location based monitoring technique.
RBM has immense potential in not only accessing and interpreting information but also in other essential functions that can facilitate solutions to the burgeoning clinical trial errors and complexities. Some of these functions of RBM software are as follows:
- Detection of errors: One of the important objectives of RBM is efficient monitoring and for that to happen, identification of errors is required. RBM software detects errors that occur in trials and provides necessary solution to issues that were previously cumbersome and unfeasible using traditional methods.
- Targeted Risk Assessment: Locating areas with maximum risks and paying attention to those rather than focusing on all sites. Prioritizing is essential when the data is voluminous as it shortens the length of the time required.
- Verification of data: It is essential to validate the information gained from the research. Accuracy helps in determining safety, potency, and quality of the result obtained from the research. Hence, verification of data is of vital importance.
- Investigation of data: In RBM, the data is collected from all sites on a central monitoring system. This information is further investigated for potential risk assessment and risk mitigation. The constant flow of data in the system allows access to real-time surveys. The data accessed can be compared and scrutinized to avoid future research complications.
- Forecasting of risk: Systematic prediction of risks ensures effective monitoring which helps to prevent and uproot potential hurdles. Foreseeing of data and using it properly to reap all the benefits acts as a good cost effective solution.
RBM works as an efficient tool to provide quality data analysis and timely risk assessment. Most importantly, it is a feasible and economical technique which greatly enhances the quality of a clinical trial or study. It acts as an important tool for risk mitigation in trials and market analysis of drugs. RBM can be used as a supplementary technique rather than replacing the traditional methods as in the final analysis, on-site monitoring is equally necessary. In addition, focusing and prioritizing the most risk affected sites could deliver the most efficient results. Ultimately, RBM software can generate effective profits by optimum utilization of resources without compromising the integrity, safety, and protection of trial volunteers and the final research.
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