TransCelerate BioPharma, an independent nonprofit focused on accelerating the development of new medicines, has released a position paper outlining a methodology for risk-based site monitoring (RBM) that could modernize and streamline the way studies are conducted and monitored.  The RBM position paper reflects TransCelerate's collaborative approach to improve speed, efficiency and capabilities in bringing new therapeutics to patients. 

The organization's goal was to establish a common approach to high-quality, risk-based site monitoring to enhance patient safety, ensure the quality of clinical data and create efficiencies.

"Biopharmaceutical companies often spend an extraordinary amount of effort monitoring clinical trials—data from each patient, for every study, at every global site, is reviewed—yet, there isn't much evidence to indicate that this level of review is effective at identifying systemic errors or substantially improving the quality of data gathered," said Dalvir Gill, Ph.D., CEO of TransCelerate. "Despite this, monitoring approaches have remained unchanged. In this position paper, we have outlined a methodology—procedures, algorithms, a toolkit—for risk-based monitoring that we believe will be effective and efficient for our member companies and others."

The RBM methodology shifts monitoring processes from excessive concentration on source data verification to comprehensive risk-driven monitoring—moving away from the traditionally reactive industry approach. Instead of relying heavily on on-site monitoring, which limits the ability to identify and prevent issues, TransCelerate's recommendations are driven by centralized and off-site monitoring techniques, as well as adaptive on-site monitoring. This approach makes it possible to oversee study parameters holistically and maximize on-site monitoring findings, bringing into balance effort and value gained, while mitigating risks and detecting any issues early, or preventing them entirely.

The RBM paper outlines a standard approach for risk-based monitoring that can be adopted for any type, phase and stage of clinical trial.  The position paper was developed in response to draft guidance from the FDA and EMA.  Both agencies have reviewed the RBM methodology paper.

"TransCelerate's RBM methodology provides the framework and tools to manage clinical trial risks through identification, categorization and appropriate mitigation, said Rehbar Tayyabkhan, executive director at Bristol-Myers Squibb and RBM project lead for TransCelerate. “We are providing tools like the RACT (Risk Assessment and Categorization Tool) and the IQRMP (Integrated Quality and Risk Management Plan), which will help companies identify and plan their risk mitigation strategies.  We also are sharing an approach that enables a balance between off-site/centralized study monitoring and on-site activities at the investigative site.  This allows for a more targeted approach."

TransCelerate invites feedback through a survey paired with the paper. The organization's member companies will pilot its RBM methodology; multiple pilots already are in motion.  Lessons gleaned from these pilots, along with feedback from the Association for Clinical Research Organizations(ACRO), Clinical Trials Transformation Initiative (CTTI) and the public, will help inform the methodology as needed.

TransCelerate's RBM methodology also will be featured in a session at DIA’s annual meeting this month in Boston.  Following completion of pilot activities, TransCelerate plans to issue a position paper clarifying the effectiveness of its approach.