WASHINGTON—While the increased use of data has the potential to accelerate the development of new and lifesaving drugs, there is currently no simple way for Americans to contribute their personal data for use in medical research. A new report from the Center for Data Innovation offers a series of policy recommendations to increase quality and availability of data to improve data-driven drug development. In particular, the report calls on policymakers to create a National Health Research Data Exchange, which would significantly expand the amount of patient medical data collected and shared for research purposes, including by allowing patients to easily donate their data, such as after their death.
“Increasing the availability of data leads to new and more effective treatments, which will improve patients’ quality of life and even save lives,” said Senior Policy Analyst Joshua New, author of the report. “However, progress in data-driven drug development will stagnate unless drug researchers gain access to the data they need to make this a reality.”
The report examines how more data, better data, and the increased ability to use data would benefit four distinct stages of the drug development lifecycle: discovery, clinical research, FDA review, and FDA post-market safety monitoring.
In addition to the creation of a National Health Research Data Exchange, the report recommends that policymakers:
- Implement a unique patient identifier to improve data integrity throughout the health care system;
- Better enforce the publication of data from clinical trial results by more diligently penalizing noncompliance;
- Develop guidance for the use of new kinds of data sources in the drug development lifecycle;
- Develop mechanisms to facilitate data sharing by biopharmaceutical stakeholders by establishing data trusts that protect sensitive and proprietary data while still making it available to researchers;
- Require and fund the Food and Drug Administration to improve the reliability of data used in drug development outside the United States;
- Develop best practices for data collection in health care to ensure equitable outcomes;
- Fully fund the U.S. National Institutes of Health to accelerate the development of the All of Us Research Program’s million-person research cohort; and
- Increase the number of workers—including high-skilled foreign-born workers—with AI skills and computer science education at all levels.
“Accelerating data-driven drug development has the potential to uncover new cures and treatments,” said New. “But to capture this potential, the United States must accelerate the development and deployment of data technologies, increase the accessibility of valuable data, modernize regulatory processes around the potential of data, and ensure the benefits of data-driven drug development flow to all.”