Convergence: Expert calls for data governance structure for collection of real-world data

MONTREAL –While regulatory acceptance of of real-world data and evidence (RWD/RWE) is increasing, there is a need for a global data governance structure outlining how patient data should be collected to ensure that data is being used in a compliant fashion, Johnson & Johnson’s Heather Colvin told attendees at RAPS Convergence 2023.

The science around using RWD may be picking up, but the policy is lagging behind, said Colvin, director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson.

“We want to be able, in industry, to use this data to support our patients, but we need to do this compliantly, and it is getting increasingly harder to get access to this data. We need to allow a system of data governance to allow data sharing and it is different in different regions,” she said. “That is a big challenge.”

Colvin spoke alongside a panel of regulators and industry representatives on the challenges and opportunities of using RWE to support regulatory submissions. Panelists agreed that there needs to be more data sharing and collaboration to drive more effective use of RWE and innovations in device development.

RWE progress being made

Colvin described the progress that has been made by regulators worldwide with respect to incorporating RWE into their regulatory frameworks.

The trend started with the US Food and Drug Administration’s (FDA) insurance of its RWE guidance in 2017, then the establishment of user fees for RWE. In 2019, South Korea’s Ministry of Food and Drug Safety (MFDS) established its RWD/RWE framework. In 2020, both China’s National Medical Products Administration (NMPA) and the EU issued guidance on RWD. In 2021, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) issued two regulatory guidances on RWD, and the Australia’s Therapeutic Goods Administration (TGA) issued a report on RWD/RWE.

“While we have a trend, we are seeing differences in these markets and how they are being implemented. Japan is very interested in the quality of the data, and they are very focused on using the data from registries,” Colvin said.

She noted that while progress has been made in these countries with respect to advancing the technical areas and the science of using RWD, the same type of progress is lacking in the policy arena. “What is really complicated is the policy and the process,” she said. “We are seeing challenges with data access. Patient privacy and data is the new currency.”

Medtronic ‘heavy invested’ in RWE

In the meantime, Monika McDole-Russell, senior director of regulatory affairs at Medtronic, said the company is “heavily invested” in RWD and RWE. At Medtronic, she leads a global team responsible for pre- and post-market activities for gastrointestinal products. The company’s use of RWE to develop and market a device represented a $5 million savings in clinical development costs, she said.

The use of RWD must be “carefully curated,” McDole-Russell said Medtronic is in discussion with FDA on the use of RWD “early and often.”

She added that all parties are still at the learning stages with respect to using RWD.

Learning together

Industry needs to collaborate and develop a set of best practices for using RWD, McDole-Russell said. “I would love to see industry sharing best practices and doing this together. I think we will get to where we need to get faster than if we are working in silos,” she said.

Daniel Caños, director of the Office of Clinical Evidence & Analysis in the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) agreed that collaboration is key. “The future is learning together by doing.”

There is also a need for global convergence around the use of RWE in regulatory submission, Colvin said. “The evidence that we use in the US should be the same as what is used in Europe and Japan,” she said.

If there is not harmonization in this area, “we will see divergence happening pretty quickly,” Colvin said.

Convergence: Expert calls for data governance structure for collection of real-world data

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