Medical experts are turning to EHR data, coupled with billing records, to help refine treatments and find new uses for drugs that have already been approved, according to NPR.
Here are five things to know:
- The FDA has authority over drug approvals. However, when it comes to a newly approved drug, physicians don’t always have accurate information on proper dosing, treatment length or which patients could be harmed by or benefit most.
“There are so many questions that remain when a drug is approved,” Janet Woodcock, MD, the director for the FDA’s Center of Drug Evaluation and Research said at a Friends of Cancer Research meeting, according to NPR. “Many of the questions are not interesting to academics so they’re not done in the academic setting, and companies are not compelled to do them… so nobody does them. I’ve been raving about this for years!”
- The answers may lie in billing information and medical records, but many healthcare professional aren’t sure whether it is OK to pull data from these sources, since they weren’t designed for research purposes. For example, some of these systems lack basic information, such as whether a patient is alive or dead.
- A pilot study supported by Friends of Cancer Research sought to review six medical data companies’ databases to see what could be gleaned about various treatment options for a type of lung cancer. Each firm revealed consistent results about the efficacy of the treatments, suggesting that information gathered from patients could be useful in medical research.
- Two key challenges the pilot faced were gathering data on patient death, since physicians and insurers don’t typically document when a patients dies, and disease progression, since medical records don’t often document in detail how a disease progresses throughout its course.
- Dr. Woodstock noted that information from clinical trials, which are largely kept separate from clinical care, should be integrated into patient health records. “We must bring them back together if we’re going to investigate interventions rapidly and thoroughly,” she told NPR. Using real-world evidence “is the key to making that happen,” she added.