Clinical trials are essential to ensure that a drug a treatment is safe for the mass market. However, the cost of conducting a clinical trial for a drug is rising like mercury on a hot summer afternoon. Jaya Kumawat discusses the benefits of Risk Based Monitoring in clinical trials to combat this challenge.
Clinical trials are scientific research studies where new drugs, treatment methods, and diagnostic procedures are applied to treating human patients in order to determine their safety and effectiveness. Clinical trials are essential to ensure that a drug a treatment is safe for the mass market. However, the cost of conducting a clinical trial for a drug is rising like mercury on a hot summer afternoon.
In the year 2003, health researchers in the US estimated that the average cost required to bring a drug to market is USD 802 million. Presently, this cost has risen to USD 5 billion, as reported by Forbes.com. 70-80% of this drug development cost is attributed to the clinical development program of the drug.
Pharmaceutical companies are struggling to manage the high costs and are constantly looking to eliminate inefficiencies in the clinical trial process in hopes of streamlining it by focusing on key elements, like management models, new technologies and creative study approaches. These trials are influenced by various factors such as patients with specific health conditions, permissions from health authorities, and seasonality. One very critical factor, which is the major contributor to inefficiencies and high budget, is Clinical Trial Monitoring, which is a traditional on-site review of trial data. Monitoring clinical trials is the most critical activity of clinical research. It ensures the safety of subjects, quality of conduct and compliance of the study.
Risk management is a concept that is practiced in almost all industries such as insurance, retail, etc. When this approach is applied to the monitoring of clinical trials, it is referred to as risk based monitoring (RBM).
RBM leaves behind the traditional approach of monitoring clinical trials that required frequent visits to the site and 100% SDV (Source Data Verification). Instead, RBM promotes centralized approach to data collection as well as monitoring.
Clinical trial monitoring is important to ensure safety of patients and maintain a high quality of data. With RBM, there is significant reduction in costs and the data quality is greatly improved:
- Less time and effort goes into review and verification of data (SDV and SDR percentage decreases)
- Data quality increases as error rate decreases
- Cost savings of up to 76% can be realized
- Focused effort on mitigating the high-risk factors increases patient safety
- Integration of data from various repositories results in increased data accuracy
- Real time data analytics allow continuous remote monitoring
The Approach that Regulators Recommend
FDA recommends the RBM approach and does not mandate 100% monitoring of a clinical trial. The regulatory body recommends taking a risk-based approach, in order to eliminate needless multiple visits to the sites so the focus is on mitigating the high-risk areas. The FDA guidance encourages using centralized methods for monitoring, as per the requirement.
In August 2011, FDA first supported RBM for clinical trials when it published “Oversight for Clinical Investigations — A Risk-Based Approach to Monitoring.” The process and the principles of RBM and risk management are put together in
ICH Q92. In November last year, the Integrated Addendum to ICH-GCP E6 (R2) advised clinical trial sponsors to go for the RBM approach.
So How Does RBM Work?
RBM focuses on high-risk areas – scientifically as well as operationally – and leverages technology and other resources to mitigate these risks.
The first step for successful RBM is risk assessment and defining the high-risk areas. Hence, it is important to identify the KRIs (Key Risk Indicators) and put in place the right triggers, alerts, and responses. After the assessment, risk mitigation and risk management strategies come in play.
at RBM can bring to a clinical trial.
Benefits of Risk Based Monitoring (RBM)
- Lower costs: More than a quarter of the cost of a clinical trial is tied up in monitoring activities. Therefore, if we can optimize the monitoring, we can significantly lower the costs.
- Faster, focused results: Due to data analysis and centralized monitoring, the results are faster and more accurate.
- Low error rate: When compared with traditional studies, RBM studies have reduced number of missing pages by 45% and brought down the critical data error rate by as much as four times.
- Real-time data entry: RBM encourages real-time data entry. Comparative studies show that sites that deploy RBM are 5 times more likely to enter study data within 7 days.
- Better focus on the primary objective: Personnel have more time to focus on their core roles and responsibilities, as their administrative tasks reduce significantly.
- Increased safety: With admin tasks reduced, resources can be allocated more efficiently, and focused towards ensuring safety of participants.
- Better compliance: Data driven insights and other digital tools facilitate early detection of problems, improved site training, and identification of potential fraudulent activities. These factors automatically results in better compliance.
- Increased collaboration: RBM encourages more collaboration and sharing among co-workers.
The climate across the clinical trial horizon has changed considerably. Until recently, on site monitoring of clinical trials was the only and most acceptable way of quality control. But the resources required for onsite monitoring are considerable. Even after deploying such cost and resource intensive process, the data is not error-free.
RBM has made clinical trials more efficient, safer for patients, and less error-prone. Next, we will look at ways in which RBM can be successfully deployed.