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RISK-BASED MONITORING- The next revolution in Clinical trials

Effective monitoring of clinical trials is a critical step while conducting quality studies and protecting human subjects. Monitoring procedures ensure clinical studies quality and subject safety, making them essential components of the process. Risk-based monitoring (RBM) ensures the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study. It is a powerful, technology-based approach that maximizes the use of your company’s data, allowing you to make smarter decisions about where to allocate resources and in what proportion. Essentially, a risk-based approach might be a better way to overcome oversight in clinical studies.

Clinical trials have witnessed drastic increases in complexity and cost over the years. Most of a study's cost can be attributed to the on-site review of trial data. This approach, heavily reliant on exhaustive source data verification (SDV), has proved to be not only resource intensive, but also limited in its ability to identify and prevent issues. Efficient monitoring is essential to protect the well-being of trial participants and maintain the integrity of results. In fact, it is now generally accepted that the process for clinical trial monitoring needs to change. Onsite monitoring methods, like any manual effort, are limited in scope and prone to error. A more centralized, risk-based approach is now the preferred method for monitoring clinical trials, as per several regulatory agencies, including the FDA.

Risk-based monitoring enables sponsors and CROs prioritize resources around risks related to data quality, integrity and subject(s) safety. With risk-based monitoring, 100% source data verification -- currently being done -- can be reduced. Targeted monitoring or monitoring based on trigger mechanisms can significantly reduce SDV, done on 100% data points as of today. This kind of monitoring can set a trigger on detecting an issue or to measure the amount of data that required SDV.

FDA guidelines speak of RBM as an alternative approach to ‘frequent onsite monitoring and 100% data verification for all trials’. An alternative approach includes centralized monitoring, while others focus on leveraging technology as a communication tool to manage risks throughout the trial. The best RBM approaches, however, involve conducting risk assessments to develop a monitoring plan for each individual study.

Protocol complexity, resource allocation, and the availability of electronic data have all contributed to the industry’s incremental focus on alternative monitoring approaches, supported by the FDA’s final guidance on RBM and the EMA’s ‘Reflection Paper on Risk Based Quality Management in Clinical Trials.’ The upcoming release of ICH E6 (R2) GCP regulations is expected to, additionally, explicitly require the application of a risk-based approach to quality management.

Implementing RBM can only be done if risks applicable to the study are well identified and a comprehensive risk management strategy is implemented. This involves defining thresholds which can be used to measure and identify issues that require action. The use of technology is important in implementing RBM. In fact, the most advanced CTMS systems can be set up to automatically flag data for review. Notifications too can be set up to notify those who need to act when an issue exists.

As the industry adopts RBM strategies, the clinical trial industry has started incorporating RBM capabilities into its tools. Such tools can be specifically programmed to limit the monitor to only a specific set of data for SDV, such as the data tied to efficacy endpoints or safety- related data. Doing so can reduce the time needed for SDV as well as the amount of monitoring visits required to be completed on site. Taken together, these significantly reduce the cost of monitoring a trial.

A Quality Monitoring plan ensures that data quality and integrity are not compromised. Such a plan includes the creation of robust edit checks to ensure data consistency and quality. A centralized monitor role reviews important data visualizations, leading to reduced clinical trial costs. Also, an in-house monitor is a less expensive resource than a remote-based CRA traveling to investigative sites to complete onsite monitoring visits.

The monitoring plan should be proportionately tailored to a trial’s identified risks. Such an approach can help the clinical trial industry drive greater quality, integrity, efficacy and subject(s) safety in clinical trial monitoring. This way, monitoring resources can be focused on the most-needed areas and trends identified more quickly.

US Food and Drug Administration (FDA) guidelines outline the following four steps in a risk-based monitoring approach:

  1. Identify critical data and processes

  2. Perform risk assessment

  3. Zero in on factors to consider when developing a monitoring plan

  4. Develop a monitoring plan specific for a particular study



A well-developed RBM strategy offers the following benefits:

  • Fewer errors -- Risk-based, centralized monitoring uses more automated reviews to determine the need for manual intervention, and is more likely to uncover errors

  • Lower cost -- With centralized monitoring, activities like onsite audits can be limited to study sites where problems are most likely to occur. This can dramatically reduce the cost of monitoring

  • Better analysis -- With all the data flowing into a central risk dashboard, statistical and graphical checks can be used much more easily to determine the presence of outliers or unusual patterns in the data

  • Cross-site comparison -- Centralized monitoring also allows you to compare data between sites to assess performance and identify potentially fraudulent data.

  • More timely results -- A dashboard also makes it possible to identify and resolve issues while the trial is in progress


The clinical research industry must consider new ways to monitor ongoing clinical trials by leveraging technology, risk-based strategies, and centralized monitoring to improve clinical trial quality and integrity, while ensuring patient safety. Risk-based monitoring also reduces costs by applying technology to manage risks. This results in faster time to market at lower monitoring costs. It also helps resources to focus on other value-added tasks.



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