Source : 'The Pink Sheet'
Pressure has been building on the US Food and Drug Administration to update and modernize its data strategy, with the coronavirus pandemic only increasing the urgency.
FDA officials will convene a virtual meeting on 30 June on modernizing the FDA’s data strategy. An in-person meeting originally was scheduled for 27 March, but the coronavirus outbreak forced its postponement and conversion to video conference.
Among the many questions the FDA asked of industry concerned the consequences or issues that could emerge as the agency moves from “‘static point-in-time data sets’ to updating digital data streams for analyses,” according to the Federal Register notice.
Continuously updating data streams could allow for more rapid assessment and analysis and quicker decision-making. However, the FDA may find it already is behind if it wants to influence the industry policy for such a move, thanks to the coronavirus pandemic.
The real-world data analytics firm Aetion wrote in formal comments to the meeting docket that there is a need for an ongoing process to monitor data quality and changes to data structure, adding that “the COVID-19 pandemic is establishing precedence, as the [real-world evidence] community builds empirical evidence.”
Aetion, which has several RWE contracts with FDA, told the Pink Sheet on 26 June that the FDA data strategy is aligned with continuous data collection needs.
The company also said that government, industry and public health researchers now realize the coronavirus requires data generated in a few days, as opposed to several months, ago and studies must reflect the real-time evolution of coronavirus and potential treatments.
“As FDA modernizes its approach, these dynamics highlight the importance of continuous evidence generation – for COVID treatments/vaccines and beyond – and of a data strategy to enable as much,” the company said.
FDA officials have created some policies governing the use of real-world evidence already. But now, many sponsors have been forced to use real-world evidence more broadly in their development programs because of coronavirus containment measures forced on traditional clinical trials.
The agency is using some real-world data projects to track coronavirus natural history and drug shortages, as well as understand treatment impact on outcomes. FDA officials have said the pandemic could help find solutions to long-standing problems that prevented more widespread adoption of real-world evidence uses. ("COVID19 Shakes Up RealWorld Data Studies" "Pink Sheet" )
In responses to the pandemic, some clinical trials have switched to remote assessments, which FDA has encouraged, but the agency has also noted that it will take a close look at the data to ensure that the shift away from in-person monitoring did not affect the trial results. ("US FDA Will Leverage Current Clinical Trial Data In Deciding On Post-COVID Flexibilities" "Pink Sheet" )
The data strategy meeting also may include considerable discussion of how to house the growing amount of data that the standards will govern.
Joe Rymsza, IQVIA VP of global pharmacovigilance and regulatory technology solutions, said in an interview with the Pink Sheet that the emphasis now is on ensuring infrastructure is easily scalable. He said data is moving into what are known as “data lakes” to support the advanced queries desired.
“Analytics platforms that layer on lakes have to be such that they are able to run intelligent queries,” Rymsza said. “Data sets that they are getting from industry and managed care organizations are increasingly diverse, but well-suited to big data analytic techniques.”
Sage Bionetworks, a nonprofit biomedical research and technology development organization, argued that the gap is not data or technology, but methodology, such as governance systems. The company suggested creating public institutions to access real world evidence, where researcher communities can grow and produce best practices.
Sage Bionetworks also wrote in a docket comment that a real-world evidence “sandbox” could serve as a secure repository and allow investigators to add their own data in secure folders.
“If we view the observatory as a public utility (like water or electricity) those who use it could be required to pay a modest fee for access to cover the costs of maintaining it,” the company wrote.
The meeting agenda includes multiple panel discussions, focusing on data sharing and related issues, as well as data exchange and the potential impact on public health.
The FDA wants the data strategy not only to govern how data is submitted to the agency, but also how it is used within its walls. In some cases, permissions need to be in place in order for the data to be shared internally, and the agency is exploring a policy for communicating findings of unexpected safety concerns for products. ("US FDA Data Strategy Will Cover Security For Internal Sharing" "Pink Sheet" )
Agency officials also are looking for ideas for enhancing the efficiency of data preparation and submission, as well as facilitating interoperability of health care and scientific data generated using scientific models, according to the Federal Register notice.
FDA’s data strategy will be coupled with its Technology Modernization Action Plan (TMAP), unveiled in September 2019. The agency expects to solicit ideas from a variety of stakeholders, including investors and tech companies, along with the traditional pharma industry. ("US FDA Tech Modernization Plans Costs Uncertain" "Pink Sheet" )
By Derrick Gingery