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What is Risk Based Monitoring?

Posted by Doctor Dan on Oct 13, 2016 11:08:01 AM

Clinical trials involved during a drug development are very costly. Some research projects require multiple monitoring, which increases the costs. Remote monitoring is less expensive, but cannot meet the accuracy level in some research projects. Thus, researchers have started the use of Risk-based Monitoring which is a popular and hassle free way to perform clinical trials.

What is Risk Based Monitoring?

Risk-based monitoring, popularly known as RBM is nothing but an approach when we target different monitoring activities, which might include 100 percent source data verification (SDV) in certain cases. It might also include data collection as well as data monitoring at every stage.


Risk-Based Monitoring - Different from Traditional Approaches

Earlier during the traditional approaches, we were able to ensure patient safety and quality data. However, with a properly designed RBM strategy, we can support enhanced practices and increase the efficiency of resources.

Moreover, RBM strategy is more of a targeted monitoring and involves source data verification, which researchers can use alternatively. It supports handling of all risks as per their priority and affects the clinical trials and its bottom line.

Why Adopt RBM in Clinical Researches?

Applied Clinical Trials published a study done in the year 2009, where it says that less than 33% respondents in Clinical Trials Transformation Initiative have used data monitoring to replace on-site visits. This study also deduces three primary reasons for clinical researchers to adopt RBM –

  • To reduce monitoring costs of clinical trials
  • Improve the data quality
  • Improve the quality of oversight

How Would You Implement Risk-Based Monitoring?

It is important to have strong communication channels for all team members involved in a research. Members must have a clear understanding of their roles and expectations. The RBM plan must be concise, information must be study specific and there should be a process to gather, analyze and act on data.

“Intelligent risk-based monitoring employs a robust quality process backed by technology to help make sense of the thousands, if not millions, of data points in a trial. To ensure you have the right tools to implement your RBM method, there are some important considerations when evaluating technologies”.  Source: http://www.bioclinica.com

The Future of RBM

Risk-based monitoring is one of the best solutions to meet the rising cost of clinical research. We’ve seen much progress and the major key players are actively taking important decisions to replace it with on-site visits. Thus, the future of risk-based monitoring in clinical researches looks bright.

Topics: Clinical Research