CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Sony Salzman spoke with David Izard, senior director, Clinical Data Standards at Chiltern. He co-authored the white paper “The Case For Embracing The FDA’s Endorsed Data Standards.”

Q: What will the FDA’s data standards mean for the life sciences industry? Can you describe the impact the December 2016 deadline had on the industry?

A: The FDA’s binding guidance related to the provision of clinical and nonclinical study data based on FDA-endorsed data standards for clinical studies has been a wakeup call to industry. Despite existing conventions to define, collect and analyze data, sponsors will now be required to provide data in this new format for clinical studies that start on or after December 18, 2016, and for nonclinical studies that start on or after December 18, 2017. This submission requirement has influenced both sponsors and service providers to evaluate how they collect, analyze, report and ultimately submit clinical and nonclinical study data and related assets.

Service providers with expertise in developing submission deliverables have been quick to react, leveraging the FDA-endorsed standards for the provision of data based on Clinical Data Interchange Standards Consortium (CDISC) standards for tabulation and analysis data, as well as the endorsed vocabularies and dictionaries such as CDISC-controlled terminology, MedDRA and WHODrug.

Sponsor adoption has been more varied as many internal systems and processes have been built over the years that are dependent on proprietary company standards. We see many sponsor efforts to revise SOPs and develop and/or revise internal standards governance processes to accommodate data standards sourced externally. In the meantime, significant sponsor effort has been poured into producing submission deliverables based on FDA-endorsed data standards on an “as-needed” basis at the time of submission preparation.

Q: What was the FDA’s motivation for developing Jumpstart, and how was it used?

A: JumpStart is a service that supports New Drug Application and Biologic License Application (NDA/BLA) review teams’ safety review early in the review cycle. It provides an assessment of the data quality and composition with interpretation to identify issues that may complicate the safety data review process. Within the first two weeks after a submission is received, the FDA will first assess and report whether the submitted data is fit for purpose. Within four weeks, the FDA will load the submitted data into review tools and perform several automated, common exploratory safety analyses with the goal of providing exploratory descriptive analyses for signal detection and hypothesis generation. This is only possible with the provision of study data based on FDA-endorsed data standards.

The FDA, via the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) and subsequent goals laid out in the Prescription Drug User Fee Act (PDUFA V), has been working on developing a more efficient submission review model that yields high-quality results when evaluating products for safety and efficacy. Services and tools such as JumpStart and DataFit play as role as part of the FDA tenants of predictability, traceability and communication, which, pursued together, will yield a more efficient and transparent review process.

Q: You wrote in your white paper, “The biggest benefit, expedited FDA review, is not one that is guaranteed, but at this point, the signs are positive.” What are the signs saying now? 

A: The FDA will never guarantee a faster review if you provide well-structured and well-documented study data based on FDA-endorsed data standards. However, FDA representatives continue to highlight in presentations and discussions at industry events that a faster review has been consistently the case. Numerous case studies have been presented that indicate that months have been shaved off the review cycle without any additional motivation (expedited review vouchers, Breakthrough Therapy designation, Priority Review, etc.). This time saving apparently has occurred solely because of the ease with which the FDA could work with the data.

We are now seeing a tipping point of a different kind as well. FDA reviewers have moved from no regard to standard data to cautious adoption, and now to enthusiastic proponents. We have seen a number of cases where data based on FDA-endorsed data standards have been requested during the review cycle despite agreements between the sponsor and FDA prior to submission that permitted the provision of data based on legacy data formats. Agency reviewers are becoming accustomed to the receipt of standardized study data and are not pleased when confronted with the notion that a number of standard analyses that services such JumpStart and DataFit could provide will require a significant amount of customized effort to produce. 

This article was reprinted from Volume 21, Issue 21, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »