April 15, 2019
Collaboration, integration and data-sharing are popular concepts in a life sciences industry focused on finding novel treatments to meet critical healthcare needs. But are clinical trials really ready to “walk the walk” when it comes to making their data accessible to other sponsors and researchers? Not just yet, say industry experts.
“The industry is a long, long way off from standardizing and collecting and sharing data,” says April Mulroney, chief data officer at WCG Clinical. “Standardizing the collection will enable the standardization of sharing, and I think we have a long way to go.”
What is needed are methods of data collection and management that are recognized by the entire clinical research field, agrees Rebecca Kush, chief scientific officer at Elligo Health Research.
Kush points to the work of the Clinical Data Interchange Consortium (CDISC) as an example. CDISC’s Clinical Data Acquisition Standards Harmonization effort features global and consensus-based data standards available for clinical trials data collection and electronic submission.
CDISC’s approach, which was developed with the encouragement of the FDA as part of its Critical Path Initiative, “streamlines the generation of tables and analysis datasets that meet global regulatory requirements for data,” Kush said. The FDA requires the use of CDISC standards in the electronic submission of applications and data.
According to Mulroney, there are a bevy of technologies in the start-up phase that may help facilitate greater data-sharing in clinical trials. The costs and hurdles associated with getting these technologies approved and adopted may be the leading reasons why the clinical trials industry has been so slow.
“The biggest barrier for us is who is going to pay for that,” she says. “Pharma has been typically unwilling to pay for data standards and platforms like this because they typically hold their cards close to their chest, and they’re not willing to share their information. I think pharma should treat their scientific IP that they have as private, but I think that the hoarding of information as it relates to sites and patients is just not helpful.”
Despite these sentiments, Mulroney doesn’t believe it’s entirely impossible. “It’s definitely been achieved in other industries that are equally regulated as ours,” she adds, “but the challenge in our industry is that we haven’t even begun scratching the surface.”
The first step is to admit that there is a problem, Mulroney says, and everyone agrees that drug development can be accelerated if data are shared. “The second step is sharing in any form or fashion,” she says, “and the third step is to create the standards that make it easier to share.”
“I think the standards for sharing have to be done as an entire industry.”
But it may be up to individual companies to lead the way. “There are a couple of companies stepping forward that would like to start sharing results from their clinical trials,” Mulroney says. “The challenge is that it’s one of those things where ‘if everybody doesn’t do it, we’re not going to do it.’ This industry is also a ‘pack mentality,’ and no one wants to be first. Everyone agrees on the value of data-sharing, but no one wants to put their chips on the table.”
-By Brandon May