Steve Young, chief scientific officer of CluePoints, will be outlining the benefits of risk-based quality management (RBQM) during several SCOPE Summit presentations this year (see the list below). Outsourcing-Pharma (OSP) discussed with Young how use of the practice has increased in the clinical research realm, as well as how the COVID-19 pandemic has helped accelerate understanding and adoption.
OSP: Could you please share a ‘nutshell’ description of RBQM and why it’s highly useful in the clinical research realm?
SY: RBQM is an approach to managing and ensuring quality in clinical research, that encourages study teams to pro-actively assess operational risk and focus their attention on what matters most to quality and patient safety. This is leading to much higher quality outcomes in research, along with lower development costs and even shorter timelines!
OSP: Please share your perspective on how industry attitudes toward and adoption of RBQM practices and principles had been evolving in the months/years leading up to COVID-19’s arrival?
SY: The principles of RBQM and RBM - along with QBD - were introduced a decade or so ago and have been gaining steadily increasing attention and interest across the industry since then. But most of the attention was educational in nature, and as is typical in our cautious industry, the actual rate of adoption was relatively slow prior to the onset of the Covid pandemic.
However, we did start to see an inflection point in greater adoption in the years following the ICH GCP revision in 2016 that incorporated RBQM principles.
OSP: Then, COVID-19 hit. How might operations with RBQM principles in place be weathering the pandemic, early on and since, as compared to companies that hadn’t yet adopted?
SY: RBQM has proven to be an essential component of success for organizations during the pandemic, especially since it encourages more reliance on centralized and remote methods of monitoring study quality and less reliance on in-person site monitoring which has been severely restricted in the past year.
OSP: Please share any ways that the pandemic, shutdown and other impacts have underscored RBQM’s usefulness.
SY: In addition to enabling effective quality oversight without the need to visit sites regularly, many organizations leveraged the RBQM risk assessment process to conduct COVID-specific risk assessments that facilitated a clear, effective plan of action to address the challenges faced during the pandemic.
OSP: I understand you’ll be sharing case studies and metrics during your presentation—do you think you could please give us a sneak peek or overview, to share with OSP readers?
SY: We have been compiling an ever-increasing number of central monitoring case studies that are compelling in illustrating the power and value of effective central monitoring. A couple of the newer use cases we will show illustrate how central monitoring statistical testing was able to retrospectively identify a site known to have significant misconduct and un-reliable data - and would have enabled the study team to identify the issue many months before they actually did.
Young is scheduled to present during the following SCOPE Summit sessions:
- RBQM/CM Implementation: Lessons from Pfizer’s COVID Vaccine Trial, Tuesday, March 2, 10: 15 am EST
- How Did We Do? A Review of RBQM’s Impact During COVID-19, Tuesday, March 2, 11:15 am EST
- Panel—Advancing RBQM: Lessons from the Trenches, Tuesday, March 2, 11:45 am EST
- Roundtable--Advancing RBQM: Tools, Strategies and Lessons Learned from COVID-19, Wednesday, March 3, 10:30 am EST
For more information about the presentation or other SCOPE Summit sessions, visit scopesummit.com.