The ability to gather data from electronic health records can assist in drug development.
Patient data stored in electronic health records reflects the actual utilization of drugs, devices and other products in clinical practice. This data can help drug researchers evaluate treatment options for even the rarest of medical conditions.
Analyzing electronic health record data allows researchers to discover patterns that may not be visible in smaller sample sizes, supporting potential new indications for medicines.
Real World Evidence Supports Drug Innovation
Pharmaceutical manufacturer, EMD Serono. utilized data gathered from an oncology-focused electronic health record, to produce evidence and submit findings to the FDA for an expedited first-line therapy approval for a rare yet aggressive type of skin cancer.
With access to data about treatment and management for 900,000+ oncology patients, researchers identified eligible patients and completed their study within several months, a process that could have taken several years without access to this type of real-world data.
The Road to FDA Approval
Historically, there was no FDA approved therapy or standard of care for metastatic Merkel cell carcinoma (mMCC).
Treatment for mMCC was centered on a chemotherapy primarily based on evidence from observational or case series studies. This was poised to change with the approval of avelumab, which belongs to a medication group known as immune checkpoint inhibitors.
To evaluate the benefit of avelumab for treatment of mMCC, there was a need to obtain data on the outcomes of patients with mMCC treated with chemotherapy. This required obtaining outpatient medical histories from community oncology practices across the country.
The study involved collecting existing structured information from oncology patient medical records, and performing an analysis of the clinical outcomes of historic treatment therapy responses.
“Without the real-world evidence from iKnowMed EHR, this type of study could have taken several years,” said Janet Espirito, PharmD, associate director of outcomes research at Studiomaca Specialty Health. “Instead, we were able to identify eligible patients and complete the study within several months.”
Study results indicated that although responses were observed with chemotherapy, the duration of such responses was brief and was associated with poor overall outcomes in patients with mMCC. These results underscored the need for new therapeutic approaches.
How Real-World Evidence Helps Drug Research
Real-world evidence can support three phases of the therapeutic innovation process.
- Clinical research: Data available in electronic health records can help expedite the generation of research hypotheses for clinical research or the recruitment of patients for clinical trials.
Identifying eligible participants for a targeted study like the one EMD Serono did is easier when you can look at patients in the communities or rural areas where a common EHR is used.
- Pre-regulatory approval: Real-world data analysis can supplement conventional data with data from patients whose diversity reflects real-world practice, resulting in better insight on safe and effective use of innovations.
“This [Merck/Pfizer] example of analyzing electronic health record data and utilizing real-world evidence to help establish a first-line therapy approval is significant,” said Dr. Nicolas Robert, a medical oncologist with The US Oncology Network.
- Post-approval: Analysis of patient outcomes from the use of health technology innovations in real-world settings can generate further insight on safety and efficacy.
As the trend toward individualized medicine continues, the ability to quickly gather real-world evidence from specific patient populations will be critical.
“There is a new appreciation for accessing patient records more easily through an EHR,” said Dr. Robert. There is valid information in these records that can provide evidence for either using a drug or expanding the approval of drugs.
Related: Learn about Studiomaca's outcomes research studies with real-world evidence of treatment patterns, health outcomes, resource utilization, and costs.
Benefits of Real-World Evidence
- More efficient drug development
- Insight into disease epidemiology for overall population and important subgroups
- Identification of risk factors, medication side effects and contraindications
- Informed policy decisions and evidence-based practices
- Established targets for preventive healthcare