We previously introduced the regulatory influence of new ICH E6 revisions. We saw that risk assessment is an important first step in monitoring efforts and to always be thinking about de-risking your protocol. Today, we will provide actionable ways to undertake an risk assessment exercise.
Cross-functional perspectives are crucial
Risk assessment must go beyond the concerns of operations or monitoring teams and span the entire organization – because the conversation is no longer just about monitoring. That paradigm has shifted completely.
When we start thinking about central monitoring teams in relation to the IQRMP (Integrated Quality Risk Management Plan), or RACT (Risk Assessment Categorization Tool), we begin to understand how those responsible for monitoring a particular risk in a trial are identifying those risks, and gain insights from them. Since our industry historically uses the term "monitoring" in relation to clinical research associate (CRA), the word became commonly associated, even synonymous, with CRAs and their duties.
When we refer to monitoring, we must look beyond what a CRA does, as this is only one component. CRAs perform 100% source document verification (SDV), but this process does not allow them to compare subjects effectively.
When assembling a multi-functional team to develop a risk assessment – considering and discussing everything from chemical compounds to the objectives of that particular clinical trial – each member brings their own expertise, which helps define endpoints, promote safety, and enriches the overall trial quality. Some examples include:
- Supply chain management. Trial complexities can result from preserving a cold chain, or a temperature controlled supply chain. Nevertheless, its management and protection are most important, as it relates to trial endpoints.
- Statistician considerations. To reach the endpoint of the trial, we must ensure that we are looking for people from different “pockets,” as endpoints are related to the exact number of patients coming from various subgroups. We’re not just including females aged 15-25, we’re including men and women from other age brackets. This could be a statistician’s risk associated with the trial.
When individuals responsible for trial safety, medical monitoring and operations are included in a cross-functional risk assessment, each can share what the trial looks like from their point of view, enhancing the discussion by accounting for and addressing all potential trial risks.
The combined approach of central monitors, site monitors, medical monitors and data managers is much stronger than review by a single CRA. Looking at trends across the study – at a patient and site level – means you are taking a much more thorough monitoring approach overall.
Change Starts From Within
Keep in mind these various skills needed to conduct a robust and meaningful risk assessment:
- Use the tools and resources at your disposal, without re-inventing the wheel
- Train individuals whose core competency is risk assessment, and who can help drive this process across all therapeutic areas:
- Clinical operations professionals are good candidates, as they interact with all of the cross-functional members. They must, however, have a good understanding of the risk assessment goals and must be involved on a continual basis.
- If not clinical operations, another key candidate is one who is clinically oriented with a clinical background. It can be difficult to facilitate this process without a clinical background, as these individuals understand when and why certain issues are raised.
- Whether senior-level study managers, or those who are well-versed in study operations, it becomes crucial to keep the “critical issues” list absolutely critical, and to elect someone who knows the difference.
Smaller companies may not have access to this level cross-functional support. At Medidata, our professional services team provides support across the board, and derives key insights and knowledge from each trial so managers don’t have to start from scratch each time they begin a new trial.
Next post, we’ll talk about when you should start your risk assessment and what it really means to document your risk assessment. Download a copy of our “Ultimate Starter Kit for RBM” eBook here to learn more.