Regulatory Challenges With Data Collection

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical trials. Data is now captured from biospecimens and digital health technologies, including advanced genetic and imaging data. Regulatory agencies require standardized data submission for analysis, but do not dictate collection methods, leaving pharma companies to develop their own standards. Lack of standards leads to inefficiencies, with only 20% of studies meeting deadlines, causing significant delays and costs. Improper data collection can lead to missed endpoints and regulatory issues. Collaboration among pharma companies and external vendors is crucial for improving data standards and trial efficiency.

A transcript of Erginer’s conversation with ACT can be found below.

ACT: While there are standards for data submission to regulatory agencies, there aren’t any for collection. Why is that?

Erginer: That's a great question, and I I'll start with answering why are there standards in the first place for submission data? The reason why those standards exist is that in order for regulatory agencies to be able to understand and pull out the results and understand the impact and safety and efficacy for a particular trial, they need that data to be reported in a very specific structure and format and terminology so that they can understand it and understand the outcomes of that trial. They also need to be able to take that data and then compare it against other clinical trials that have been done before, so having that data in that very end point submission standard makes it a lot easier for them to be able to do all those comparisons.

In contrast to that, the only other requirements that they have in terms of the data structure and format is that they do require that sponsors can demonstrate how data has changed from data collection through the various stages of structures and formats and terminology throughout the course of the life cycle. They don't at all have any requirements or authority to govern how that data collection is done. Really, the burden of trying to come up with those data collection standards would fall onto the pharma companies, because it's really their responsibility and their remit to be able to conduct trials efficiently, so having a better control over those and understanding and capturing in a meaningful way how that data and structure changes over time really comes down to the pharma industries, and it's difficult. I think that the biggest challenge is that there's not really a good organization who can lead that effort, so in the past eight years ago is when the CDISC regulations were put into place to make sure that all studies being submitted to FDA followed those structures and formats. In the last eight years, they've worked out a lot of the different kinks in there, but I think there's still some challenges to go. Now, trying to get everyone together and collaborate without a really good, centralized organization to do that, is difficult, and it will require both industry collaboration between pharma companies, as well as all of the various external vendor data providers, so the ones that are delivering the data to them to really come together to make those standards.