
Electronic health record data and real-world data, collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials. We can use existing data to plan eligibility criteria, assess trial feasibility and generalizability, and target recruitment efforts to shorten timelines and enhance patient access to research efforts. Appropriately sharing data and methods with all researchers and sponsors can spark collaboration and innovation in clinical trials. In CTTI’s 2030 vision for clinical trials:
- Clinical trials are enhanced by the integration of new types of data, such as consumer and digital data.
- Data are accessible, with appropriate governance and controls, to all researchers and sponsors.
- Use of EHR data and other relevant available data from trial participants is straightforward.
- Linkage with health plan claims data for trial participants is simple when beneficial for trial conduct.
- Data platforms support multiple clinical trials, rather than being built for individual trials.
- Choices of data sources and methodologies correspond to the level of evidence needed to answer the research question and considers how the study results will be used.
- Data standards and definitions are in place to support integration of data from various sources, and the systems are interoperable.
- Common standards exist to address privacy and security in an easily implementable and transparent manner.
Resources
CTTI Launches New Online Digital Health Trials Hub
Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.
