At the Veeva R&D and Quality Summit in Copenhagen, Rinke Riezebos sat down with Vanguard to discuss the operational realities of running pediatric oncology trials, where the patients waiting for studies to open are children with no other treatment options. As Team Lead for Clinical Data Provisioning and Interim Manager of Data Intelligence, Riezebos oversees statisticians, clinical data managers, and data scientists, including a clinical data management team of roughly 18. His message to sponsors who want Princess Máxima’s participation is clear: collaboration works better than one-sided processes.
“Listen to your sites, listen to your partners, and try to collaborate together — not just push what you think is necessary. In my experience so far, that’s quite often the case.”
Moe: How does the mission of treating pediatric oncology patients shape the day-to-day pressure on your team?
Rinke Riezebos: It’s really my team. I’m leading several teams: statisticians, clinical data managers, and data scientists. Everybody is really focused on getting these trials up and running as fast as possible. By being able to do these trials, we are able to provide, as a center, drugs that are not regularly on the market. Through these trials we can give them to the patients and hopefully help them get better.
Moe: How does Princess Máxima’s dual role as both sponsor and site change how your teams communicate internally?
Rinke Riezebos: We have a trial and data center — a department of around 130 people — running all clinical trials at our center. We have trial managers leading the different protocols, clinical data managers setting up the databases, and PIs who are responsible for the studies and handle discussions with pharma. On the site side we have local data managers, research nurses, and so on.
Having both the site and the sponsor in the same center really helps us, because as a sponsor we get early feedback from our own site. At the same time, we are really separated. We’re on different floors, because a site should be separated from a sponsor.
Moe: How do technology systems help ease the friction between your sponsor and site teams?
Rinke Riezebos: Systems can help us by giving clear insight into data quality. We are working on several areas to get better insight into the data and data oversight, but also on data standardization, which is a Máxima-wide collaboration between site and sponsor.
My vision as team lead for clinical data is also to be able to provide participating sites with insight into their own data. What I see now is that as a site you send in the data, and as a sponsor you review the data and send back queries. By giving sites better tools and more control and insight into their own data, we can make that process more efficient and improve collaboration.
Moe: How does involving clinical data managers early in protocol design affect how a trial runs?
Rinke Riezebos: We have the luxury of having both site and sponsor in-house, so we closely collaborate on these elements together with the PI and the sponsor. We try to include the clinical data managers immediately from the start when writing the study protocol, to assure: can this be built? Can we adhere to the standard eCRF forms that we have? Researchers like to collect a lot of data, but it’s not always necessary for the aim of the study. Having that discussion up front, rather than shortly after the start of a study, is really helpful and also optimizes the speed of the trial.
Moe: Why does standardizing processes matter more than just standardizing technology?
Rinke Riezebos: I’m really interested in eSource, for example. These kinds of tools can help sites work more efficiently. But I think we have to standardize, and that is about speaking the same language — not only in language itself, but in communication, organization, and processes, and aligning those.
Once we’ve standardized processes and aren’t reinventing them every time, I think that will really help us run more efficient clinical trials. It’s hard. It’s about communication and trust, and being willing to trust each other. Once we’re able to create a standardized process and a standardized data flow, there will be less need to send as many queries as we do now, and also less need for monitors to focus on separate data elements. The work shifts to looking at the processes instead.
Moe: How has Princess Máxima’s team evolved internally to keep pace with the specialization sponsors bring?
Rinke Riezebos: Industry has a lot of expertise and focused teams that are specialized in specific areas. As an academic research hospital, most people wear different hats. We don’t have the luxury of growing as big as larger sponsors, but I’m always looking at how we’re organized and asking whether this is really the most efficient way, or whether we should specialize more.
That’s actually what we’re doing. My clinical data management team is around 18 people, and over the years I’ve seen us growing into more separate sub-teams with more and more specialization.
“Once we are able to create a standardized process and a standardized data flow, I think there will be less need to send that many queries as we do now — and also less need for monitors.”
Moe: What’s the one thing sponsors should stop doing today if they want sites like Princess Máxima to choose to run their next trial?
Rinke Riezebos: Listen to your sites, listen to your partners, and try to collaborate together — not just push what you think is necessary. In my experience so far, that’s quite often the case.
Rinke Riezebos is Team Lead, Clinical Data Provisioning and Interim Manager, Data Intelligence at Princess Máxima Center for Pediatric Oncology.
This content is sponsored by Veeva Systems.
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
