How FDA is Approaching Change Management in New Data Efforts

The Food and Drug Administration is leveraging patient experience data for regulatory decision-making, with change management of its workforce key to the next steps in this digital transformation.

The effort stems from FDA’s June report, titled “Assessment of the Use of Patient Experience Data in Regulatory Decision-Making,” which outlines methods used to identify, collect and analyze patient data in decision-making.

“FDA will use this report to support its efforts to enhance the use of patient experience data in regulatory decision-making, which can help ensure that as a medical product is developed, it is developed in a way that takes into account the needs and priorities of the patients who will use the product,” Mary Ann Slack, director of the Office of Strategic Programs with FDA’s Center for Drug Evaluation and Research, told GovernmentCIO Media & Research.

Over the past year, FDA has accelerated data efforts to create modern data solutions like blockchain, genomic information and real-time analytics. The agency has experienced dramatic increases in data collection, especially following the onset of COVID-19.

“Technological advances have and will continue to revolutionize human and animal health,” Janet Woodcock, FDA’s acting commissioner, said during a budget hearing in June. “As a byproduct of these exciting advances, the amount and variety of data that FDA generates, needs and uses is rapidly increasing, but we’re often hampered by antiquated methods.”

FDA’s Center for Drug Evaluation and Research was, and continues to be, a central hub for FDA’s COVID-19 response and for patient data collection to ensure quick delivery of therapeutics for public health.

CDER’s new report provided recommendations to the FDA on how to better communicate and expand the use of patient experience data in regulatory decision-making with external stakeholders.

“The FDA is committed to improving collaboration efforts with drug-approving regulatory agencies in other countries, and to increasing transparency related to the scientific basis for drug approval decisions,” Slack said.

FDA is working across multiple fronts to support these data efforts and apply best practices, including collaborating on data standards through what it calls “standards development organizations.” This work has improved CDER’s data evaluation process and development of data standards policies.

Key to these efforts is change management to ensure the workforce is ready for the technology shifts. Slack noted that FDA needs continued buy-in from leaders and industry partners.

“Within the FDA, we are seeing a lot of interest in the inclusion of the patient perspective. Patient listening sessions and patient-focused drug development meetings attract a large number of staff from across FDA. There are multiple training courses that provide our reviewers with enhanced understandings of the methodologies behind the development of clinical outcome assessments or preference studies,” Slack said.

Change management for this effort includes the oversight and management of the entire portfolio of changes and process, including all the components of change control, Slack said.

In a “pharmaceutical quality system,” change management applies across the entire product lifecycle, Slack said. A company should have an effective change management system to evaluate, approve and implement changes. She said that the change management system should include:

• Quality risk management to evaluate proposed changes; the level of effort and formality of the evaluation should be commensurate with the level of risk.
• Evaluate changes relative to the marketing authorization, including current product and process understanding and/or design space, where established.
• Expert teams, with appropriate expertise and knowledge, should evaluate proposed changes.
• Evaluate changes after implementation to confirm the change objectives were achieved.

“Of course, there are challenges, and the report on patient experience data really captured some of them. Not all staff are comfortable with [clinical outcome assessments], and not all of the patient experience data we receive are of sufficient quality to be used for regulatory decision-making. But we are moving in the right direction,” Slack said.