As the need for faster, more precise, and more equitable research increases, biopharma companies are constantly searching for new ways to leverage the huge amount of valuable information that surrounds them.

These promising assets include data generated in prior clinical trials (pCTD) as well as the enormous wealth of real-world data (RWD) that exists in electronic health records, disease registries, medical device data repositories, and other patient-generated data sources.

Harnessing this data to augment clinical trial activities requires data platforms that can aggregate, extract, curate, and present high-value findings in a way that ensures accessibility, standardization, equity, and trustworthiness.  

In short, data platforms generate meaningful insights while acting as the guardians of quality: the non-negotiable building block of any clinical investigation.

But not all data platforms are created equal, and not all data companies are employing the same techniques to produce reliable and consistent results, notes a recent white paper from the Clinical Research Data Sharing Alliance (CRDSA).  

As innovation advances, the data companies that create and provide these platforms need to understand the basic principles of how to  curate and share high-quality data in order to positively contribute to the clinical research environment.

Assessing the challenges of the evolving real-world data environment

 

Historically, agencies like the FDA and EMA haven’t used RWD or pCTD at scale to inform regulatory approvals.  However, this is changing as  data and platform companies continue to demonstrate the value of these types of data. But,challenges still remain for product sponsors looking to integrate this type of evidence into their submissions, as well as for the platform companies seeking to provide these data types for novel use.

Sponsors have to contend with a wide range of issues, from accessing reliable and high-quality  patient-level data and submitting them in an approved format to complying with regulatory audit and inspection requirements.  At the platform level, the slew of privacy regulations and disparate terms for data access from each of the originating data sources often hinder scale and efficiency.   

Platform companies that can successfully act as a high-quality bridge between data sources and data users will be essential for achieving the promises of next-generation clinical research.

Recommendations for data platform companies to help advance secondary use of RWD and pCDT

The CRDSA asserts that data platform companies can either add to these challenges or assist with breaking down the barriers.

To accelerate the use of pCDT and RWD for regulatory submissions, data companies will need to develop a cohesive approach to generating insights that consistently meet the requirements of government agencies.  

To help guide the industry in the right direction, CRDSA has provided a series of recommendations for how data platforms can and should evolve to support future research driven by non-traditional sources.

• • When re-using prior clinical trial data, platforms should focus on trials that have been previously submitted to health authorities for regulatory review, since these trials are likely to already follow established guidelines for regulatory submissions. If the platform also includes trials not previously submitted, they should clearly label each type to make it easier for sponsors to discuss the implications with regulators.

• • When collecting RWD from disparate sources, platforms should follow clearly defined and documented processes for curating the data.  Explicability and clear provenance are key for demonstrating quality and reliability of data for submissions.  All RWD datasets should include documentation of changes, alterations, deletions, or transformations performed.  If the data is to be used for a regulatory submission, sponsors and data platforms should discuss requirements for data format (i.e.,  SDTM format).

• • RWD platforms, in particular, should engage in robust quality assurance processes, including audits and inspections, and make insight into their processes open and available to audit by regulatory authorities if necessary.  Transparency will be crucial for supporting the development of a secondary use community built upon a foundation of quality and trustworthiness.

Integrating pCDT and RWD more deeply into the regulatory approvals process can significantly change the way new therapies come to market quickly and safely.  It will be essential for all data platform companies to embrace these principles and commit to working with biopharma companies, researchers, regulators, and data source providers to create a standardized, open, and collaborative future for clinical research.