Left floundering in a communications vacuum, any risk-based monitoring program simply won’t ever get off the ground, says Mike Caswell, vice president for clinical evaluation at the Consumer Product Testing Company. It’s critical to seek out and incorporate comments from “different stakeholders,” including sponsors, principal investigators, research staff, and financial officers.
Without a clear understanding of RBM, you “won’t get buy-in from sites and RBM won’t work,” Caswell stresses.
However, open communication is only half the solution. You’ve also got to know the right questions to ask. When risk-based monitoring is employed, gone are the days of simple questions such as “paper or electronic CRFs?” or “frequency of monitoring visits?” to plan site and sponsor workload, anticipated timelines, and projected costs.
Risk-based monitoring requires a team-based approach that tends to be more loosely structured – providing opportunities for efficiencies, but also exposure to inefficiencies.
For example, if an in-house clinical research associate (CRA) is deemed the primary point of contact, but the data management team members and/or medical monitors reach out to site personnel without looping in the in-house CRA, they can all end up asking the site the same question about the severity of an adverse event that appears “off” compared to the other data. As a result, potentially three people have spent time on the same task; the site staff is bombarded about the same thing three times and can easily become frustrated about the triplication of work required. Efficient? No. Cost-Effective? No. Communication in check? No.
So what can be done to prevent these issues? What should every study team member involved in reporting and monitoring trial data be thinking about when planning the study?
Communication is obviously key, but so is knowing the right questions to ask.
- What are the possible risks to the study?
- How are potential risks mitigated, and by whom and when?
- Who will look at what data point and when?
- How would a delayed data entry by a site impact this review?
- Who is the primary point of contact (sponsor/CRO to site and site to sponsor/CRO)?
Knowing the right questions to ask when planning for risk-based monitoring, and actually asking them, is critical to development of a successful monitoring plan and can improve trial efficiencies, reduce costs, and keep trials on time.