Why Drug Developers Can't Ignore the Advantages of RBM
September 12, 2018
Risk-based monitoring (RBM) is defining the future of clinical decision making. As this new approach to clinical monitoring continues to take root, Sponsors in today’s drug development market need to know what RBM is, why it is important, and how Biotrial is incorporating RBM into its everyday service portfolio.
“Monitoring” is defined by the FDA as “a quality control tool for determining whether study activities are being carried out as planned, so that deficiencies can be identified and corrected” (FDA, 2013). Typically, pharmaceutical, biotechnology, and medical device companies – and the CROs representing them – opt for “on-site monitoring,” whereby monitors assess up to 100 percent of a study’s data and performance at the clinical trial site. However, drug developers are now faced with new challenges as to how trials are monitored due to a significant increase in the amount and complexity of clinical trials in the last 20 years. Although on-site monitoring is still the most prevalent approach, both the 1996 ICH guidance on good clinical practice (ICH E6) and the 2011 ISO Clinical investigation of medical devices for human subjects – good clinical practice (ISO 14155:2011) allow for adaptability in how trials are monitored. This is predicated on key parameters of the trial (e.g. objective, design, complexity, etc.). According to the FDA Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, “increasing use of electronic systems and records and improvements in statistical assessments, present opportunities for alternative monitoring approaches…that can improve the quality and efficiency of sponsor oversight of clinical investigations.”
What Exactly Is Considered an “Alternative Monitoring Approach?”
One alternative monitoring approach, “Centralized Monitoring” enables clinical site data to be assessed remotely by data managers and statisticians in addition to on-site assessment by clinical monitors. This approach reinforces human subject safety through readier detection of data anomalies, and presents both financial and logistical benefits that Sponsors cannot afford to ignore in the Digital Age.
Another alternative approach and the subject of this article, “Risk-Based Monitoring,” is an approach to clinical monitoring applicable to certain parts of a clinical trial. It augments trial efficiency even further by focusing Sponsor oversight where it matters – on the risks likely to pose a threat to data quality, human subject protection, and trial integrity – without compromising overall supervision.
Why Risk-Based Monitoring Is Important
According to TransCelerate, a non-profit organization which developed guidelines for targeted, risk-based clinical trial monitoring, “the resource solutions generated by [risk-based monitoring] could lead to improvement in data quality and patient safety for clinical trials and reduction in effort expended on low-value activities” (TransCelerate, 2017). Additionally, like centralized monitoring, RBM can be more relevant than earlier monitoring methods (e.g. 100% source data verification (SDV)) because it promotes increased cross-departmental coordination. What does this mean for the Sponsor? Higher data integrity and confidence at an earlier stage of the clinical trial process.
A greater degree of integration across different development team members is a key difference between on-site and alternative monitoring approaches like RBM, and an exciting evolution of the clinical oversight process. Traditionally, monitoring approaches have been the domain of the clinical project management team with data managers and other disciplines playing important albeit defined supporting roles. RBM presents an opportunity for harmonized participation, bringing together clinical project managers, data managers, statisticians, and clinical trial site staff at each stage of the process.
The Biotrial Approach
As part of Biotrial’s commitment to providing Sponsors with the best solutions for their clinical trials, we are currently utilizing RBM in several ongoing studies. We approach Patient Trial Management with adherence to international working best practices and rigorous quality standards. This allows us to meet increasingly stringent study milestones and budgets in order to continually satisfy our Sponsors’ specific needs.
If you are involved in Data Management, Operations or would like to discuss our experience in RBM, stop by booth 407 at the SCDM conference, September 23-26 in Seattle, Washington to discuss how we can plan and execute a regulatory compliant RBM study for you.