By Benjamin Ross

July 13, 2018 | The Clinical Data Interchange Standards Consortium (CDISC) recently named Peter Van Reusel its new Chief Standards Officer; the group is hoping to move into a new phase of standards in clinical trials.

When speaking with Clinical Informatics News, Van Reusel recalled his initial involvement with CDISC when it was first developed over 20 years ago. Even though the organization was small, he was impressed with its focus on all aspects of clinical research.

“I attended one of their first industry standards meetings in Washington, DC,” he said. “I saw CDISC evolving from a relatively small, volunteer-based organization into a global entity developing clinical data standards for all ranks of healthcare and data.”

Now, it’s Van Reusel’s job to make sure the organization is still running 20 years from now by making sure its standards are continuing to be adopted, not just by companies in the industry, but also by important regulatory agencies like the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

“This means that when any of these companies are preparing to submit for regulatory approval, that they need to use the CDISC standards in order get an approval for their product,” said Van Reusel.

Machine Futures

The standards already created by CDISC have become the “de facto” language to exchange data, according to Van Reusel, although he believes improvements are still necessary with an ever-changing industry like clinical research.

“We should ask ourselves, where do we go from here?” he said. “We have the chance to keep using what we already have and keep maintaining our foundational standards... However, an interesting path we are going to walk is ensuring that data standards become much more usable by machines.”

One of Van Reusel’s first tasks as Chief Standards Officer will be to implement new sets of semantic interoperable standards. To do this, Van Reusel said CDISC is going to create a pilot layer of additional data standards, displaying the relationship of the organization’s metadata in biomedical concepts instead of data models in columns and rows.

“We want to create meaningful relationships between data points,” he said. “What we have seen in the industry from early implementation is that this methodology is proven to provide the next level of automation and the next level of end-to-end functionality.”

CDISC and Van Reusel don’t just want to run this pilot in house, Van Reusel told Clinical Informatics News. “We want this to be very inclusive, inviting stakeholders and our user community. We want to show them this new technology, but also ensure that they’re on board with this new way of representing data standards.”

A blue-ribbon commission has been created to discuss how the standards pilot will work in relation to CDISC’s current system, a CDISC representative reported to Clinical Informatics News. A full recommendation is expected by Q4 of this year.

According to Van Reusel, this new direction of displaying standards is a major reason for his taking the job at CDISC.

“This is a very critical point in time,” he said. “This has been evolving for the past 15-20 years in the right direction, and right now we are at an inflection point. I’ve been given the privilege and the challenge of being a part of the start of something completely new.”

Van Reusel’s goal is to assist those who work with the data on a daily basis.

“If I’m successful, that means that we’ve all been able to do something for our community, to give back not only to those who are using our data standards, but also eventually to the patients.”