Five myths of risk-based monitoring (RBM)

First, some monitoring basics…

Sponsors of human clinical trials that evaluate new drugs, biologics, and medical devices are responsible for maintaining a high standard of quality and ethics. This means that they must ensure that study participants’ rights, welfare, and safety are protected, and that accurate data are collected, analyzed, and reported to the U.S. Food and Drug Administration (FDA). FDA requires that sponsors use monitoring as a quality control to ensure oversight of their studies, but is not specific about how this should be accomplished. One existing model is for the sponsor to send either staff or contracted Clinical Research Associates (CRA) to the investigational sites to review patient medical records, study specific records, and compliance with the regulations. Historically, these CRAs verified 100% of the data collected for each patient against the medical record. It is called 100% Source Data Verification (SDV) when every data field is verified against the medical record, or source document.

What is risk-based monitoring?

The FDA guidance for risk-based monitoring states that monitoring, or oversight, alone is not enough to ensure quality, but that an overarching objective of quality should be built into the processes and procedures for executing a clinical trial. In a webinar on RBM produced for the Society for Clinical Research Sites, Quintiles Director Jan Higgins states,

“RBM is an overall concept versus specific monitoring approaches”

Where RBM should include targeted risk-based monitoring that focuses on areas of a given study with higher risk for error, adverse events, or non-compliance, AND triggered risk-based monitoring, where detailed monitoring is prompted following certain high-risk occurrences, such as frequent protocol deviations or adverse events.

Monitoring approaches used in RBM can be a combination of traditional in-person CRA visits and alternative approaches. One common alternative approach is remote monitoring, which allows monitoring activities that were conducted previously on-site to be completed remotely. This includes activities like SDV and query resolution. The percent of SDV monitored may be reduced from 100% to focus on critical data fields. Another alternative is centralized monitoring, which identifies trends in data where problems may be identified early in the study.


We present five common myths about RBM:

Myth #1: RBM is less vigilant in overseeing clinical studies.

FDA recommends that a quality risk management approach be employed, and states that this approach, focuses sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity”. A risk-based approach is dynamic, which facilitates real-time improvement of trial oversight and conduct on a continual basis. Over the past few decades, risk-based monitoring approaches have been shown to improve the reliability and verifiability of study data.

Myth #2: An up-front risk assessment isn’t efficient.

A one-size-fits-all approach to monitoring isn’t efficient. An up-front risk assessment for each study will identify and evaluate risks to key study data, systems, and processes that encompass all study activities, not just monitoring. Monitoring is one mechanism to assess the status of those critical data points. The efficiencies come from focusing on key risk areas, and from the ability to adjust to issues that arise during the course of a study in a dynamic, real-time way.

Myth #3: Implementation of RBM is cost-prohibitive.

Cost savings versus improvements in data quality are not mutually exclusive. The Trials Without Tribulations Blog reports on a global phase III trial with 3,386 patients where RBM reduced the percent SDV needed with a corresponding decrease in the error rate. They concluded that using RBM in that study resulted in a 76% cost savings over a traditional monitoring model.

Myth #4: RBM doesn’t improve study quality or patient safety.

Malcom Burgess, Ph.D., in a 2013 ICON white paper entitled, Less is More: Risk-Based Monitoring of Site Performance, reported that problems can be identified and remedied early with RBM, which protects patient safety and study integrity, and that CRAs can be more efficient to focus their attention on sites that need the most help. Because RBM can allow sponsors to move quickly from identifying trends in the data to implementing preventive or corrective actions, problems can be avoided or mitigated early.

Myth #5: Sites won’t perform if the sponsor doesn’t visit in person.

RBM doesn’t mean sites are ignored or expectations are reduced. Sites are expected to prepare for regularly scheduled remote monitoring calls just like they would for an on-site visit. Experienced, competent sites can operate efficiently with fewer interruptions by on-site visits, and sites that need more help and encouragement can receive it through focused efforts identified through RBM.

The evidence provided to clarify these five RBM myths point to some of the key benefits to implementing an RBM process: increased patient safety, study compliance, and staff efficiency, as well as potential cost-savings. As part of a successful implementation, sponsors should focus on establishing robust RBM processes, providing adequate commitment to the up-front risk assessment and management process, and on high quality training of staff and sites to the new RBM approach to monitoring.

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