The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry.

The strategy for FY 2024 to 2027 acknowledges the growing importance of technology in drug and device development, as well as the challenges that accompany fast-paced scientific progress and innovation. IT-focused upgrades will be needed to keep up with ever-evolving technology and therapeutics, says Vid Desai, chief information officer for the agency’s Office of Digital Transformation.

“We are responding to rapid advancements and changes in demand from FDA’s regulated industries, competing for scarce IT talent, understanding use cases for emerging technologies (such as [AI]), enabling business process modernization, optimizing investment management, and continuing to break down barriers to data sharing and collaboration, all while protecting the assets, intellectual property, and personal information the public entrusts us with,” he said.

The agency’s approach, intended to address outdated data-exchange practices, unstructured data submissions, unnecessary data-sharing limitations and other hurdles, encompasses six key objectives:

• Create a “shared ecosystem” by encouraging crossfunctional investment in technology, bolstering collaboration channels and broadening access to data and shared resources across the agency and with external stakeholders;
• Continue efforts to strengthen the agency’s IT infrastructure, including efforts to build the capacities to avoid technology-related disruptions, adapt to workload changes and catch issues before they affect stakeholders;
• Modernize the agency’s enterprise IT services and capabilities;
• Identify, utilize and share data that are critical to stakeholders;
• Adopt innovative AI and ML solutions in a responsible manner; and
• Grow, retain and bring in IT talent and leadership.

For example, the FDA’s IT modernization endeavors will include development of agency solutions for finance and budgeting, human resources, inspections, acquisitions, Freedom of Information Act (FOIA) requests and complaint management. In addition, the agency plans to bring its cybersecurity capabilities up to date, retire dated systems, applications and devices, and develop stakeholder-informed IT solutions, such as a next-generation Electronic Submission Gateway.

The FDA’s vision for data-sharing will see it apply AI solutions to data governance and management with the intent of improving data quality and security, as well as the speed and accuracy of agency decisions and insights. The agency will also work to better prioritize data most valuable to stakeholders, pursue advanced data analytics and improve the interoperability and security of data exchanges between the agency and its partners.

Its plans for adopting AI envision an environment that supports, shares and assesses innovative IT approaches that can help improve operational efficiency, drive the development of new agency capabilities and ultimately lead to usable innovations.

Read the FDA strategy report here.