As you may well know, much of the early work in Risk-Based Monitoring has focused on relatively simple Key Risk Indicators (KRIs) and traffic-light dashboards, which are easy to understand. However, there is now a growing requirement to complement this approach with a more sophisticated and comprehensive analysis of data using a Central Statistical Monitoring (CSM) methodology. At CluePoints, we’re interested to know your thoughts on how companies are going to adopt these complementary approaches to ensure data accuracy and integrity in their trials?
Unlike the other Risk-Based Monitoring topics discussed over recent weeks, when we spoke with a number of our partners about this, the responses were quite wide-ranging, so we’ve tried to provide a quick overview for you in this post (for their full responses, please see here). We would love to hear your views and experiences on this matter too, so please feel free to get the discussion started!
The majority of our partners were in agreement that we are likely to see an increase in adoption of Central Statistical Monitoring across the industry over the coming years due to the advanced capabilities and value that the technology offers. Angie Maurer, Co-Founder & CEO at Zynapsys commented: “These systems deliver not only more transparent and efficient data but the sophisticated technology ensures data is also much more robust, so I think we will definitely see an increase in adoption.” An opinion echoed by Steve Young, Senior Director of Transformation Services at OmniComm Systems, who said: “Advanced Central Statistical Monitoring capabilities, that can identify outliers and unrealistic data patterns, are crucial. The industry is becoming more interested in this approach and as a result, I think adoption rates will increase significantly in the near future.”
Oracle Health Sciences’ Senior Director of Life Sciences Product Strategy, James Streeter, thinks that we are likely to see the use of Key Risk Indicators (KRIs) reduce over time, saying: “For now, what we are likely to see is companies adopting an approach which combines the use of Key Risk Indicators (KRIs) and Central Statistical Monitoring, to give them a broader picture of the potential risks within their clinical trials. As study teams begin to understand that Central Statistical Monitoring provides them with more access to real-world data, coupled with the increase in data being collected from emerging technology, the use of Key Risk Indicators (KRIs) will diminish.”
In terms of practical implementation, Adam Butler, Senior Vice President, Strategic Development & Corporate Marketing at Bracket Global urged sponsors to ensure they develop a strategy which addresses all of the potential risks that could arise when collecting data, and when doing this, utilize Risk-Based Monitoring and Central Statistical Monitoring as support tools. Jamie O’Keefe, Vice President, Life Sciences and R&D Practice at Paragon Solutions, thinks that we will see a divide between large and smaller companies, commenting: “It will be much more achievable for smaller organizations to integrate Central Statistical Monitoring and adopt this new approach across all of their trials. The challenge for big pharma companies will be changing existing complex infrastructure. Trying to drive this change through multi-million dollar, multi-year implementations, will be a huge task and have a significant impact on business.”
While Jamie thinks the adoption of Central Statistical Monitoring could be easier for smaller organizations, Angie Maurer thinks that budget will have an influence for smaller companies and would like to see providers develop a flexible platform that will allow even small start-up companies to afford this new technology.
Finally, Steve Young raised an interesting question about who within an organization should take responsibility for the management of Central Statitstical Monitoring. In Steve’s opinion, while data managers are not statisticians, they have the data analytics skills, so will be best equipped to work with the monitoring team to translate data into an appropriate remediation action.
In our own experience to date, it is evident that Central Statistical Monitoring is just as applicable for small Pharma as it is for Large Pharma and CROs. The ‘light checks’ offered by Key Risk indicators (KRI) functionality certainly provide companies with an operational tool to regularly check data and drive reduced monitoring activities. However, most of the companies that CluePoints works with have identified that they also want to also use an independent and objective approach to comprehensively interrogate the data. Using the KRI approach only focuses on 15-20 largely operational variables, whereas CSM leaves no stone unturned in comprehensively analyzing all the clinical data within a study. The result is as rigorous and scientifically validated health check of the study and identification of anomalies within the data that can be examined and course-corrected to ensure patient safety and improved accuracy and integrity. The regulators also favor this approach and the revised ICH E6 guideline document also helps sponsors and CROs alike to determine how Central Monitoring should be best approached. The gold medal position is for sponsors to harness the power of both KRIs and Central Statistical Monitoring to ensure improvement and integrity of the data throughout their studies and reduced risk when it comes to submission.
