Former FDA Commissioner Dr. Robert Califf Offers a Glimpse of the Future of Clinical Research
The U.S. clinical research enterprise is undergoing enormous changes. Find out how new technologies, research methods and regulations are converging to reshape national approaches for generating evidence to guide healthcare decisions.
In a webinar now available as a recording on the CTTI website, Dr. Robert Califf offers his insights on the ongoing transformation of clinical research in the era of “omics,” big data, and activated patients. Drawing on his experience as a clinician, researcher, and most recently, head of the FDA, Dr. Califf surveys the current landscape of clinical trials, which despite incremental improvements are beset by rapidly rising costs and still fall short in providing the kinds of high-quality evidence needed by clinicians, patients, and policymakers.
However, he also notes that recent advances in technology, research methods, and patient engagement, further accelerated by provisions in the 21st Century Cures Act and the Food and Drug Administration Safety and Innovation Act (FDASIA), can provide the key elements needed to enable a more effective and efficient learning health system. These include:
- Continuous engagement with patients as active participants throughout the entire research process
- Innovation in approaches that can accommodate enormous quantities of biological information while also leveraging newly accessible “real-world data” to complement more conventional research methods
- Development of networks that enable secure data sharing and bidirectional learning
- Adoption of common standards for data storage, transfer and curation
- Renewed focus on streamlining of processes for clinical trials that promote efficiency and remove barriers