Risk-Based Monitoring in Clinical Trials

paperworkRisk-based monitoring (RBM) is a method that uses risk algorithms to assess the right level of clinical trials monitoring. Food and Drug Administration (FDA) and European Medicines Agency (EMA) currently encourage this approach.

RBM focuses on improving quality of the data and helps to reduce the time consumed and costly on-site 100% source data verification. At times, 25-30% of the whole clinical study budget could be spent on the costs of monitoring (personnel, travel, expenses etc.). Implementing RBM can help to reduce these costs.

There are many other reasons for developing RBM. One of the main reasons is that it could help remove problems that are created through the traditional way of monitoring such as: lack of broadly understood principles; methodology and approach as well as terminology; scope of tasks; deliverables; roles and responsibilities while planning; conducting analysis; reporting and assessment of clinical trials. Additionally, it’s thought that important decisions concerning risks are not based on well-defined and objective criteria but are actually made on the basis of individual or teamwork assessments and opinions. Some observations indicate that there is limited emphasis put on the foundation of RBM with it’s usage restricted to the review of data and ignoring other respects of the study e.g. design of the protocol. It is linked to the fact that often no integrated quality management strategy is implemented. Such strategy should be the foundation of the design of the study, site selection, study management and general oversight aspects. Another problem is lack of sharing risk assessments within and between sponsors. RBM is a risk-based approach developed to manage all these problems.

The application of RBM in clinical trials is growing, especially for Phase II studies. Results of the global survey conducted by the Metrics Champion Consortium  (MCC) in 2013, reveal that all respondents were using some sort of RBM tools. Majority of stake holders (85%) continued traditional on-site monitoring involving 100% source data verification (SDV) activities, while more than a half reported using in the same time some type of RBM program on a pilot basis, or across a full program.

The most popular RBM programs involve on site monitoring with reduced SDV, or remote monitoring with support of the central data analytics (CDA). The methods of remote monitoring include the usage of data analytics reports, remote source data verification and patient profiling, which means monitoring individual study subject reports.

The reasons for adopting RBM varied among different stakeholders. Contract Research Organizations (CROs) and academic research institutes chose to implement RBM to reduce monitoring costs, whereas pharmaceutical and biotech companies chose it to improve quality oversight.

Implementing RBM also has many other advantages. Effective risk management requires a structured approach for risk identification, analysis and control. The system of risk management should be repeatable, reproducible, sustainable and adaptable in meeting regulatory demands and achieving quality outcomes. It outlines a systematic approach for the assessment, communication, control and review of risks related to the respect of quality. Implementing RBM can also help to facilitate many other aspects of the clinical trial, like site selection, qualification, protocol design and subject enrollment.

It seems like implementing RBM strategies would only be possible for big companies and institutions, but the truth is that designing and implementing RBM does not depend on the size of a company. All of interested stakeholders face similar problems e.g. lack of resources, time pressure and growing regulatory requirements and can benefit from developing an effective risk-based approach.

Another myth about RBM is the conviction that it’s implementation can be successful only with the aid of highly sophisticated IT systems. Sometimes, the simplest spreadsheets would be sufficient, but with the growth of study complexity, scope, number of arms and comparators more complex tools that minimize the workload may be needed.  All in all, IT software is not an essential element of the RBM strategy. The basis should be the overall philosophy inclusive identification of risks, analysis of their impact, likelihood and detectability. For such assessments no specific IT systems are necessary.

There is also an opinion that implementing RBM may influence the way of writing protocols and setting up trials. Of course some changes may be needed to improve the overall quality of the study. Indicated fields of improvement are: reaching planned recruitment targets, ending the study on time and on planned budget, launching proper number of amendments, delays and additional costs due to compliance flaws.

The organization, which is interested in developing the Risk-Based Monitoring programs rose as RBM Consortium. It associates quality risk management industry experts, risk-based technology firms, data analysts and biopharmaceutical business strategists. RBM Consortium is a transnational alliance to improve awareness of RBM in clinical trials and give advice to interested stakeholders on the area of quality risk management and methodologies in RBM.

Due to its many advantages and overall interest in ensuring best quality data, RBM seems to be gaining more and more followers and may become the gold standard of risk-monitoring activities in the area of clinical trials.


Risk-Based Monitoring in Clinical Trials, Applied Clinical Trials, May 2015

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