Data from electronic health records and other digital tools can improve research that helps bring new drugs to market, according to a new report from the Bipartisan Policy Center.
Drugs go through several phases during their research and development, including several clinical trials. However, those trials are currently limited, the report's authors note, because they’re not being used in a real-world population of patients for whom the treatment is intended. For instance, the participants in diabetes trials don’t have the comorbidities that most diabetes patients have. It’s also hard to recruit patients for clinical trials.
Data from EHRs, lab systems, registries and even patient monitoring devices provide huge amounts of information that would be useful for regulatory decision making, and can complement the data generated through controlled trials, thus helping in drug discovery, development and approval of new cures and treatments, according to the report.
For instance, the real world electronic information can expedite the generation of hypotheses and inform the design of studies, enable more efficient and targeted recruitment of patients for trials, reduce the burden of data collection and reporting and identify safety and operational issues sooner. This data can also improve monitoring of drugs after FDA approval by making monitoring more personalized to the patient and more frequent.
The report's authors recommend improvements in:
- Regulatory clarity regarding the use of real-world evidence
- Method and data quality for generation and use of real-world evidence
- Policies for information sharing to support clinical research
They also suggest further exploration of new adaptive pathways to modernize drug development and support personalized medicine.
To learn more:
- read the report