For the past few years, regulatory bodies, industry advocacy groups, and private companies alike have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks in an effort to achieve higher quality outcomes. NAMSA’s method was first described in the white paper “Risk-Based Monitoring: A Cognizant Approach”. In the midst of all the buzz about Risk-Based Monitoring (RBM), focus has largely been on defining a Sponsor/CRO’s methodologies for risk-assessment and adjusting monitoring activities to most effectively address those risks. NAMSA’s latest white paper, “Risk-Based Monitoring: Exploring the Clinical Site Experience”, focuses on the impact these new strategies have had on the clinical sites that play the role of first line of defense for quality data and patient safety. Drawing from the expertise of industry authorities, including the collective experience of NAMSA’s own clinical personnel, this document will provide recommended methods for Sponsor/CROs to address concerns in an effort to strengthen the partnership with clinical sites, thereby enhancing the quality and functionality of the RBM approach.
In reviewing available literature on the impact of RBM on sites, three main themes emerge as significant concerns for clinical sites in regards to RBM. First, there is a gap in understanding between site and Sponsor/CRO in regards to the implications of applying the strategy. This has led to misunderstandings and assumptions from both parties. Second, is a concern with fair compensation for the change in services the site provides and the tasks which they are asked to perform. The third theme that emerges is that in practice, introducing RBM has challenged relationships between Sponsor/CRO and site due to misunderstandings and a decrease in face-to-face contact.
The following are key activities that address these main concerns. Attention to these areas should lead to more successful RBM trials.
- Increase communication and education regarding an RBM plan to site personnel. Begin the conversation as early as possible in the qualification process. Use the site’s prior knowledge and experience with RBM as a starting point to discuss the details of the plan and address concerns expressed by the site.
- Rethink compensation. Sites need to feel they will be fairly compensated in order to get their buy-in to an alternative monitoring strategy. Open communication and education on the core principles of RBM can help clarify the purposes of the strategy. Include discussions on elements that may be new or out of the ordinary for sites such as remote monitoring, variable monitoring frequency, and payment terms. Focus on negotiating the site study budget in light of the monitoring plan seems to be what sites are asking for.
- Invest in relationships. The nature of the risk-based approach can actually be used to foster a closer relationship with sites—signifying focus is shifted from a historically after-the-fact, correction approach to non-compliance, to a more preventative focus. Activities, such as centralized review of aggregate data throughout the study and timely remote data review, can be presented to sites as ways the Sponsor/CRO is working for the benefit of the study and the site to catch trends and errors early in order to prevent more long-term issues that will affect the site’s reputation. The focus afforded by RBM should be leveraged to aid in communication and cohesion that is the result of sharing a common cause.
By utilizing strategies such as early education on RBM, transparent and creative budgeting, and a deliberate approach to maintaining partnerships, the RBM trial has the potential to strengthen relationships and quality of clinical trials.
You can read and download a copy of the “Risk-Based Monitoring: Exploring the Clinical Site Experience” white paper here.