Randomization is crucial to reduce selection bias between participants in clinical trials. eClinical data platforms should make randomization processes more efficient, but finding novel ways for reducing selection bias requires novel approaches.
In a recent webinar, the independent medical device company Solventum discussed how it landed on just such an approach – by randomizing teeth – with the cloud-based, eClinical platform provided by Zelta by Merative.
Solventum manages around 45 clinical studies, with an estimated two-thirds conducted in healthcare and dental facilities, around the world. Approximately one-third of these studies are conducted by Solventum internally with participants at an in-house facility, focusing on the company’s medical and dental products.
Hosting trials in-house like this helps Solventum eliminate the need for site selection, reduce training requirements, and increase efficiencies. Speed is of the essence in these processes – which is where Zelta came in.
“Our in-house clinical studies move very fast,” said Krista Dahling, Supervisor of Clinical Data Management for Solventum, in the webinar. “These studies are testing new concepts from the development team and they want answers fast. So, we are continually looking for new efficiencies in our trials,” added Dahling.
Handling randomization complexities in clinical trials
In the webinar, Dahling explained Solventum’s highly innovative approach to a clinical trial where teeth were enrolled as individual subjects. The study was set up to allow for one tooth to be enrolled over a set period. Participants could return a month later to have another tooth enrolled in the study if required – with the most being five teeth from one participant.
Given the complexities of these trial requirements, more creative problem-solving was needed. Teeth were linked to a subject ID to reduce duplicate data entry. In another study using the Zelta platform’s randomization model with two clearly defined stratifications, teeth were then paired with those of a similar size.
A trial build process designed from scratch to accommodate these intricacies would be a considerable undertaking. However, Zelta’s flexible Electronic Data Capture (EDC) platform supports customized trial models for precise needs. In the case of the Solventum trial, the Zelta platform helped to reduce the trial build timelines significantly based on learnings from previous studies and importing existing clinical libraries.
“Zelta helps expedite the build process because we can import from previously built studies,” added Dahling. “It worked out pretty slick.”
Measuring the success of eClinical platforms
Solventum measures success by the number of studies it can build that meet its internal timelines. Previously, the company would design the screen where the end-user would enter their data. This allowed the company to match the screen to the paper source in the trial, which helped reduce the data entry errors. With the advent of direct data entry, Zelta’s ability to create the screen versus having to build each screen individually offered a significant advantage.
“It’s a huge benefit and time saver. The methodical flow of the screen makes for very effective data entry,” said Dahling. “But we also measure success by the overall preventable error rate of a database. It’s important for the end-user to operate a user-friendly and intuitive EDC system like Zelta so data entry is efficient. Having the ability to correct those data entry errors in real-time saves a lot of time and money.”
To watch the full webinar and learn more about how Zelta by Merative facilitates innovative approaches like Solventum’s, click this link.
