From The Editor | September 11, 2014

Risk-Based Monitoring: Keeping Clinical Trials A "Human Endeavor"

By Anna Rose Welch, Editor, Biosimilar Development
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Anna Rose Welch

Approaches to Risk-Based Monitoring (RBM) are becoming increasingly important to sponsors, CROs, and investigative sites in the clinical space. However, with the evolution of these approaches comes the need for improved communication and relationships with investigative sites in order to ensure clinical trials remain a valuable and human concept.

Clinical Leader reached out to Camie Britton, Senior Director, Strategic Account Management for PAREXEL International to learn more about the benefits of centralized monitoring and to gain insight into best practices for implementing centralized monitoring at investigative sites.

Anna Rose Welch: Have you implemented centralized monitoring? What led to your adoption of this, and what effect has centralized monitoring had on RBM in general?

Camie Britton: Risk-based monitoring (RBM) approaches – including centralized monitoring – continue to be fertile ground for innovation and value creation that serve sponsors, CROs, and investigative sites alike.  It is important to note that what constitutes ‘centralized monitoring’ for the pharmaceutical industry has evolved considerably in recent years. Current definitions of centralized monitoring typically focus on the collection and interrogation of operational status and clinical data to adapt site monitoring and other clinical research interventions in accordance with various risk thresholds.

PAREXEL’s earliest efforts in centralized monitoring began in 2002 with an emphasis on providing off-site monitoring support via centralized monitoring hubs to investigative sites engaged in non-interventional research. Through our experiences, we’ve found that centralized monitoring has led to site monitoring cost reductions, enhanced data quality, improved regulatory submission and inspection outcomes, and the ability to provide seamless, tailored support to investigative sites.

Welch: As more sites experience different approaches to RBM in the industry, how do you articulate to investigators and site staff what RBM is (and is not)?

Britton: Given that RBM is generally comprised of various approaches driven by project and protocol-specific features that often vary study to study, it is important to explain to investigators exactly which risk-based tactics will be utilized for their specific protocols (targeted monitoring, centralized monitoring, remote monitoring, intelligent SDV, etc.). It is also of paramount importance that investigators be informed of how implementation of those approaches will impact on-site monitoring visits, site data collection, and the ways and means by which sites interact with sponsors and/or CROs. 

Risk-based approaches must be designed and implemented in such a way that sponsors/CROs aren’t simply transferring risk and administrative burden to investigative sites. In risk-based paradigms, sites have every right to expect well-designed protocols and data collection instruments that are the outcome of rigorous risk-assessment and feasibility. They also have the right to expect that these protocols are supported by robust operational and risk management planning and ongoing data surveillance at the project level. 

Welch: What challenges have you run into when implementing RBM, and what steps have you taken to resolve these issues? 

Britton: Many contemporary discussions of RBM focus on flexible resourcing models required to support risk-based approaches, without adequate understanding of the effects risk-based monitoring can have on relationships between investigative sites and monitors, particularly within large, global studies.

As sponsors/CROs deploy risk-based monitoring activities, issue management and the number of staff remotely engaging sites for various monitoring and data collection purposes can fragment, proliferate, and accelerate, ultimately undermining the site relationship and negatively impacting data quality and patient safety. 

We have worked extensively with sites to fully understand what RBM looks like from the site perspective and have refined our resourcing models in a manner that preserves both continuity and proximity within site relationships.  In our experience, the relationship with a site is a critical variable within RBM algorithms and plays a central role in identifying which monitoring adaptation is fit-for-purpose.  Even with the process and technology advances represented by RBM, clinical research remains a very human endeavor.