Have you had a chance to read the latest TransCelerate paper on risk-based monitoring (RBM)?
If not, I highly recommend getting your eyes on Technology Considerations to Enable the Risk-Based Monitoring Methodology, published online in August on behalf of the Drug Information Association (DIA). This paper serves as a tremendous resource for any organization interested in new enterprise technology to help realize the advantages of risk-based monitoring.
Authors Shelly Barnes, Nareen Katta, Neil Sanford, Thomas Staigers, and Thomas Verish lay out high-level considerations when selecting a potential RBM technology solution to employ across an organization's portfolio. Thoughtful discussion describes desired capabilities and system attributes including: end user requirements; predictive analytics; reporting and visualization; data sourcing, aggregation, and integration; algorithms; and other considerations.
TransCelerate's current thinking expressed in the paper closely aligns with ours here at BioClinica, especially our Compass team. I'd like to share with you three points in particular that have proven critical in my own experiences working with organizations to implement RBM methodologies and quality management strategies.
Successful RBM Implementation is Largely Dependent on People, Process, and Technology
As when an organization implements any significant new process or strategy, change management will be a critical factor with risk-based monitoring implementation. Technology alone will not guarantee success. Systemic change must occur across three levels:
People – Changing course from "how we've always done it" to quality management strategies and RBM methodology will require a whole new mindset on everyone's part. Shifting gears cannot happen without your clinical trial teams fully understanding the basis of your quality management process before it goes into effect.
Additionally each team member must know exactly how his or her role will be evolving. Clearly defined roles must be communicated to each team member and training on the new methods provided. Without this important "people" piece, the process is destined for failure.
Process – Risk-based monitoring is based on quality management principles that rely on a well-tested method (think "Plan, Do, Check, Act"). Successfully transferring these principles long-employed in the practices of other industries to clinical trials will require a clearly defined process and workflow.
Technology – Every organization has its own operating models and technology landscape. Before introducing an RBM foundational tool into your clinical trial environment, be certain it supports your people, process, and clinical trial workflow. Some important considerations when selecting potential technology include: ability to report on key data; guidance about actions to take; and clear analytics that show what's happening in your trial without requiring interpretation by individual users.
Every Clinical Trial is Unique
A technology must be flexible to accommodate the unique needs of the study protocol. Therefore, insist on a technology that has protocol-specific capabilities to prioritize risk indicators, set metrics, and adjust performance thresholds based on expectations of the protocol. RBM is not a "one-size-fits-all" methodology; it is a well-thought-out risk mitigation methodology and is entirely dependent on each unique study protocol.
The Monitor cannot be Removed from Risk-Based Monitoring
Risk-based monitoring does not mean the elimination of onsite monitoring. Rather it is a more relevant, meaningful method of analyzing trial and site performance. An RBM technology-enabler like Compass goes even a step further, providing an "intelligent monitoring" solution to ensure that each one of your sites receives the support needed to perform best.
Operational metrics and clinical data alone do not provide an accurate picture of site performance and/or needs. Feet on the ground at sites is still an important element of clinical trials today. The ideal system will incorporate bothquantitative data and qualitative data in the form of monitor feedback in order to truly understand and make impactful improvements to site performance, thereby enhancing overall clinical trial performance.
When it comes to ensuring a successful approach to risk-based monitoring, there's so much more to say so stay tuned for upcoming blogs to be posted soon.
Meanwhile, read the full paper today and get insight into TransCelerate's current thinking and gain perspective to move forward with your own RBM methodology and quality management strategies.