PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives. We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera. You are currently reading part 2 of the 2-part series.
Narrator: Last time, we met Patty and Emma and learned about their experiences as CRAs using different methods of monitoring. In today’s episode of “As the Trial Churns,” we join them as they conduct their investigator site visits. What challenges will they face?
Scene 1: Patty has settled into her monitoring room for the day; she is fortunate enough to have it to herself, though it sounds like the space next door is in use. She has received general direction from the study’s trial manager, and it is heavy on patients that need to be SDV’d for an upcoming data cut. With only 2 days on site and a focus on SDV, there’s a real chance she may not have time to visit the pharmacy and lab (again). The site’s remote access unfortunately requires significant site staff time and input, so remote visits often don’t result in as many pages SDV’d as expected. As a result, there is a lot riding on this on-site visit.
After a few hours of churning through patient records and SDV against the CRFs, Patty’s neck feels rather tight. Seems like it’s a good time for a quick break and a warm cup of tea. She steps out of the monitoring room at the same time as the neighboring door opens. It’s Emma.
Scene 2: Emma has settled into her monitoring room for the day; it’s nice to have a space to herself, though it sounds like there’s activity in the space next door. Looking at the data-related priorities the centralized monitor has provided, she should be able to complete the bulk of it today and keep her visits to the pharmacy and correlative lab tomorrow. A robust risk-based monitoring process with good remote access allows for maintaining high quality in the study data while conducting fewer on-site visits. Those on-site visits can then focus on things best done at the site like inspection of samples or study drug and meeting with site staff to build relationships.
Things weren’t always so smooth with this site, especially in the early days of the pandemic. Its remote access systems simply required too much time and effort for the staff to effectively handle. Her company eventually worked with the site to bring temporary third-party staff to the site to help, after some persuasion. It was a considerable cost up front, but it made keeping up with remote monitoring possible and should avoid the costs of additional CRA time and resources down the road to get caught up.
With about half the data-related action items addressed, Emma decides it’s a good time to get up for a walk and some fresh air. She steps out of the monitoring room at the same time as the neighboring door opens. It’s Patty.
Scene 3: After their surprise reunion, Patty and Emma decide to catch up over dinner that evening. They are surprised at how different their recent experiences with monitoring have been. Patty was aware of RBM and different approaches to monitoring, but has not had a chance to experience this strategy for herself. A quick search reveals evidence that RBM not only reduces costs, but improves data quality and oversight, even with major disruptions such as a global pandemic, and loses essentially nothing compared to 100% SDV. If anything, RBM allows for identification of data discrepancies and trends that might otherwise be buried under the need to get through CRFs in the 100% SDV model (1, 2, 3). These are things that Emma had expected, but she was nonetheless pleased to find her thoughts supported by evidence.
After the bill is paid and they part ways for the evening, Patty mulls over their conversation on the way back to the hotel. She decides it will be worth making a case for implementing RBM at her company, even if it will take some time to get people on board.
Narrator: And as the evening closes, we see a path forward for monitoring and managing ever more complex studies without having to also exponentially increase CRA time and site visits. Who knows what innovations await… As the Trial Churns.
At PROMETRIKA, we work with our sponsors to determine which RBM approaches best meet their research needs and operational strategy. Our experienced Clinical Trials Management Team works with Data Management,Biostatistics and various other functional area stakeholders (either in-house or as selected by the sponsor) to implement the best fit-for-purpose monitoring strategy.
- Barnes, B., Stansbury, N., Brown, D., Garson, L., Gerard, G., Piccoli, N., Jendrasek, D., May, N., Castillo, V., Adelfio, A., Ramirez, N., McSweeney, A., Berlien, R., & Butler, P. J. (2021). Risk-based monitoring in clinical trials: Past, present, and future. Drug Information Journal, 55(4), 899–906. https://doi.org/10.1007/s43441-021-00295-8
- Sullivan, L. (2015). The current status of risk-based monitoring. https://www.appliedclinicaltrialsonline.com/view/current-status-risk-based-monitoring
- FDA. (2013). Guidance for industry: Oversight of clinical investigations – A risk-based approach to monitoring. Guidance for Industry (fda.gov)