The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs). Created through a collaborative process between MDIC, FDA CDRH, and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be incorporated into product development and regulatory decision-making in support of clearance or approvals of IVDs. It also outlines considerations for appropriate designs and statistical methods for generating real-world evidence (RWE) for regulatory submissions.

“Understanding the accuracy of diagnostic tests requires data elements that are not as widely available as those in the therapeutic space and entails a different approach to data integration and analysis,” said Jeff Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health. “The FDA will continue to engage with stakeholders to identify and evaluate the feasibility of different approaches and new data sources. We hope efforts to gather and assess real-world data, such as the MDIC framework, will help all of us advance these efforts.”

Industry partners in creating the Real-World Evidence Framework for IVDs were Abbott Diagnostics, Genomic Health, Hologic, IBM Watson, ICON plc, Johnson & Johnson, Roche Diagnostics, Sysmex America, and Thermo Fisher Scientific. Individual experts in regulatory science and policy, epidemiology, and biostatistics also participated in the process.

A Step Forward in Using RWE for IVDs

The Real-World Evidence Framework for IVDs builds off CDRH’s guidance Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The framework focuses on considerations related to RWE for IVDs, where the agency and industry have less experience than with other devices. “MDIC’s framework document represents a step forward in providing the valuable information that IVD manufacturers and others need to address those considerations and facilitate use of RWE,” said Danelle Miller, JD, Chair of the MDIC IVD Real-World Evidence Working Group and Vice President of Global Regulatory Policy & Intelligence at Roche Diagnostics.

“We hope the framework will stir the conversations and actions needed to facilitate greater use of real-world evidence in regulatory decision-making, and ultimately, accelerate patient and healthcare provider access to innovative IVDs that are safe and effective,” said Miller.

While work on the framework for incorporating RWE into regulatory decision-making for IVDs began several years ago, the COVID-19 pandemic underscores the importance of developing safe and effective IVDs and the role that RWE can play in that process. “As we work to control the COVID-19 pandemic and plan for future healthcare challenges, the use of RWE can expedite the development of IVDs. This will allow us to leverage the power of diagnostic testing for patient management and public health,” said Pamela Goldberg, MBA, President and CEO of MDIC.

COVID-19 RWE Project Will Apply Framework

In partnership with FDA CDRH and industry partners, MDIC has launched a COVID-19 RWE project to apply the framework. One sub-project will bring together teams from industry, FDA, integrated healthcare systems, and MDIC’s SHIELD program to link electronic laboratory data from COVID-19 diagnostic tests to electronic health records to facilitate the conduct of surveillance studies and cross-institution studies. SHIELD is designed to improve the quality, utility, and portability of electronic laboratory data by harmonizing data standards.

This project will team industry partners with FDA to design clinical study protocols for the use of RWE for COVID-19 serology and molecular diagnostic tests, using the framework and HHS’s common data elements for in COVID-19 test reporting. The protocols will then be piloted with healthcare systems’ electronic records.

Source: Company Press Release