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Crystal Stone and Amanda Coogan of Remarque Systems discuss how an RBM approach can help enhance the safety and efficiency of clinical trials.
In today’s competitive clinical trial environment, sponsors and contract research organizations (CROs) are under intense pressure to move drug candidates safely and efficiently through clinical trials. Adoption of a risk-based monitoring (RBM) approach can help enhance the safety and efficiency of clinical trials, while automating labor-intensive data analysis and improving data quality. As the FDA encourages drug developers to integrate digital technologies into the development process, biopharmaceutical companies are increasingly turning to automated clinical trial software solutions that incorporate RBM.
Dynamics accelerating the trend toward RBM
RBM has garnered attention among the clinical research community since the FDA published its industry guidance, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” in August 2014. In the intervening years, though, adoption has been slow and implementation has been challenging.
With the recent update to the ICH Guidelines for Good Clinical Practice and the FDA’s draft guidance on “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers,” which was published in April 2019, regulatory focus on RBM has intensified. In fact, RBM has emerged as the standard for clinical monitoring.
Other factors are also accelerating the trend toward RBM. Industry-side emphasis on modernizing and optimizing the efficiency of clinical trials is driving digitization of the development process, from recruitment and data collection to adherence and data analysis. Further, the push toward precision medicine and biomarker-guided drug development has led to an increase in the volume and complexity of data generated by clinical trials. With nearly 80 percent of data scientist time spent collecting, cleaning, and organizing data sets, there is a strong demand for automated solutions. 1
Overcoming five challenges of transitioning to RBM
RBM technology is an automated solution that can help sponsors and CROs implement comprehensive monitoring strategies from a single platform with built-in workflows and advanced analytic capabilities. As RBM software solutions evolve to keep pace with the rest of the clinical trial landscape, it can be overwhelming for sponsors and CROs to make the transition to RBM. Here, we’ve outlined five key challenges associated with adopting an RBM approach and how they can be addressed to ensure a smooth transition.
Given the cross-functional, multi-disciplinary team required for a successful RBM implementation, some sponsors and CROs may have resource or knowledge gaps within their organizations. For companies that are considering integrating RBM into their organizations, there are a variety of external resources, ranging from online training to risk/quality management consultants and RBM software vendors, that can help them navigate the decisions needed for a successful RBM technology implementation.
Taking Advantage of the Benefits of RBM Technology
A common misconception is that primary goals of RBM are to reduce source document verification (SDV) and decrease the frequency of on-site monitoring visits. In reality, RBM is part of a broader trend toward risk-based quality management which encompasses the entire ecosystem of processes sponsors put in place to identify, assess, control, communicate, and review the risks associated with a clinical trial. Within this larger context, RBM technology is software that:
Implementation of RBM has the potential to bring a number of measurable benefits:
Automation. Some RBM technologies utilize machine learning to alert stakeholders and decision-makers about potential risks that may have been overlooked during trial set-up. By analyzing data collected during the trial on a prospective basis, these technologies can identify patterns and anomalies.
Improved patient safety and data quality. RBM technology provides notifications when issues are identified at the patient-, site-, or study-level. By continuously tracking trend information and making actionable data readily available, RBM technology enables sponsors and CROs to take corrective action in a timely fashion, improving both patient safety and data quality.
More Effective On-Site Monitoring. Apart from investigator fees, clinical monitoring is the largest driver of clinical trial costs, accounting for over 60% of study-related labor costs. With RBM analytics, on-site visits are triggered by study-specific risk thresholds-rather than being performed on a pre-defined schedule-which may lead to reduced, but more effective, on-site monitoring.
Efficiency. Data cleaning at the end of a study can be extremely time-consuming. Implemented correctly, RBM can help shorten the timelines for evaluating study data. RBM technology evaluates data on an ongoing basis, which can help reduce the time from the end of the study to the reporting of study results.
Compliance. Regulatory agencies are demanding more robust assurances of patient safety and data quality. Drug developers who leverage an RBM technology with traceability and audit capabilities are well-equipped to meet current and emerging regulatory requirements.
Getting Started. With a combination of proactive planning and the right people, processes, and technology, sponsors and CROs can minimize the growing pains associated with RBM implementation. Investing time in getting an RBM technology implementation right enables drug developers to leverage this automated solution to manage risk, facilitate communication, and get the insights they need to make informed decisions, all at their fingertips.
Crystal Stone, Risk-Based Monitoring Senior Product Specialist, Remarque Systems; Amanda Coogan, Risk-Based Monitoring Product Specialist, Remarque Systems
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