One way to speed up clinical trials: go straight to the data with electronic health records

Scientific knowledge, measured by the number of published articles, is estimated at doubling every 17.3 years. However, it takes a an average of about 17 years for health and medical research – from basic laboratory studies on cell cultures and animals to human clinical trials – to result in real changes patients see in the clinic.

The typical medical research process is generally not well equipped to respond effectively to rapidly evolving pandemics. This was especially evident before the COVID-19 pandemic, in part because the virus that causes COVID-19 often mutates. Scientists and public health officials often have to constantly struggle to develop and test new treatments to match emerging variants.

Fortunately, scientists can bypass the typical research timeline and study treatments and interventions as they are used in the clinic in near real-time by leveraging a common source of existing data – electronic health records, or EMRs.

We are a team consisting of one epidemiologist, pharmacist And cardiologist at the University of Pittsburgh Medical Center. During the COVID-19 pandemic, we realized the need to quickly study and disseminate accurate information on the most effective treatment approaches, especially for patients at high risk of hospitalization and death. In our recently published researchwe used EMR data to show that early treatment with one or more of five different monoclonal antibodies significantly reduced the risk of hospitalization or death compared to delayed or no treatment.

Using EMR data for research

In the US, healthcare systems typically use EMR systems to document patient care and for administrative purposes such as billing. While the data set is not uniform, these systems typically include detailed reports that may include sociodemographic information, medical history, test results, surgical and other procedures, prescriptions, and billing costs.

unlike single-payer healthcare systems that integrate data into one EHR system, such as in the UK and Scandinavian countries, many major healthcare systems in the US collect patient data using multiple EMR systems.

Having multiple EMR systems adds a layer of complexity to using such data for scientific research. To address this, the University of Pittsburgh Medical Center has developed and maintains a clinical data repository that collects and harmonizes data across the seven different EMR systems used by its 40 hospitals and outpatient clinics.

Simulate clinical trials

Using EMR data for research is not new. More recently, researchers have been looking at ways to use these large health data systems mimic randomized controlled trialswhich are considered the gold standard study design, but are often costly and take years to complete.

Using this emulation framework, our team used our institution’s EMR data infrastructure evaluate five different monoclonal antibodies approved by the Food and Drug Administration for emergency use for the treatment of COVID-19. Monoclonal antibodies are man-made proteins designed to prevent a pathogen – in this case the virus that causes COVID-19 – from entering human cells, multiplying and causing serious illness. Initially, the authorizations were based on clinical trial data. But as the virus mutated, subsequent evaluations based on cell culture studies suggested a loss of effectiveness.

We wanted to confirm that the findings from cell-based studies applied to actual patients. Therefore, we reviewed anonymous clinical data from 2,571 patients treated with these monoclonal antibodies within two days of COVID-19 infection and compared them with data from 5,135 patients with COVID-19 who were eligible for but failed these treatments or three or got three times. more days after infection.

We found that overall, people who received monoclonal antibodies within two days of a positive COVID-19 test reduced their risk of hospitalization or death by 39% compared to those who did not receive treatment or received delayed treatment. In addition, patients with compromised immune systems reduced their risk of hospitalization or death by 55%, regardless of age.

Our near real-time analysis of COVID-19 patients treated with monoclonal antibodies during the pandemic confirmed the findings of the cell culture studies. Our findings suggest that by using data in this way, researchers can evaluate treatments in times of urgency without conducting clinical trials.

Appropriate Use of EMR Data

Many healthcare facilities have EMR systems that researchers can use to quickly answer important research questions as they arise. However, because this clinical data is not collected specifically for research purposes, researchers are required to do so design their studies carefully and use rigorous data validation and analysis. They must also take great care in harmonizing data from different EMR systems, selecting appropriate patient samples, and minimizing all sources of potential bias.

New pandemics and major public health challenges are likely to emerge abruptly and in unpredictable ways. Given the wealth of data routinely collected in the U.S. health care systems, we believe that careful use of this data can help answer pressing health questions in a way that is representative of who actually receives care.