Risk-Based Monitoring

RBM and changes in quality management are impacting study teams, CRAs and sites.

With the introduction centralized monitoring in a risk-based monitoring (RBM) approach, the central monitor is emerging as a key and important role.

Good clinical trial risk management involves good protocol design and study operational design at the sites.

Using the five steps to a risk management plan from other industries--Identify, Assess, Plan, Track and Control--to inform a RBM approach in clinical trials.

Infinity Pharmaceuticals will use Medidata's RBM solution in an upcoming Phase III oncology study for patients with indolent non-Hodgkin lymphoma.

TransCelerate’s Risk Assessment and Categorization Tool (RACT) has exhibited usefulness with study teams and has guided organizations, such as Cancer Research UK (CRUK) to adopt their own RBM questionnaires

CBI’s conference proves RBM was just the beginning. Now companies are honing in on the risks and mitigations related to clinical trial data reporting.

The ability to have access to real-time information through leveraging technology combined with a strategic business perspective allows companies to implement a true quality management system.

While we become empowered with the technological enablers of centralized and statistical monitoring, it can be challenging to envision the respective functions of DMs and CRAs.

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OmniComm Systems, a global provider of clinical data management technology, announced survey results from respondents that included 16 sponsor organizations and 13 contract research organizations (CROs).

 Quintiles announced the addition of advanced statistical monitoring and predictive analytics capabilities to its risk-based monitoring (RBM) solution. Predictive and Advanced Analytics provide model-based capabilities are fully integrated into the solution and are underpinned by Quintiles Infosario® technology platform. These new capabilities are intended to improve precision in risk identification by better understanding underlying “white noise” from safety trigger processes. 

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach.

With the clinical trial industry’s focus on improving monitoring efficiency and leveraging a variety of risk-based monitoring (RbM) models, novel eClinical technologies are emerging to facilitate clinical trial monitoring productivity.

“Never assume that something obvious is true,”

Clinical trial patient retention and dropout continues to be an issue amongst biopharmaceutical sponsors, as patient dropouts minimize the statistical power of clinical trial data, requiring study teams to enroll additional patients.

Often overlooked in early evaluation of RBM are the tools and technologies required for successful implementation. Without the right tools to track and prioritize the shift from traditional monitoring to RBM, successful implementation is doubtful, posing detrimental consequences not only for the monitors, but also the overall trial.

That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.'

The concept of risk-based monitoring (RbM) is evolving, as nonprofit organizations continue to collaborate with the biopharmaceutical/medical device industry to investigate, pilot and implement RbM practices.

Redefining this paradigm may help dispel current misperceptions around RBM and better deliver on the promise of this growing approach.

While capable of conducting high-quality trials, the current oversight process can be expensive and inefficient.

Steve Powell, PRA Executive VP Clinical Informatics and Late Phase Services Talks About Risk-Based Monitoring (RBM)