COVID-19 is changing the practice of medicine before our eyes. The healthcare system is working with educated guesses. But we need real data to inform who is truly at risk and how to best treat and prevent this deadly disease. TARGET-COVID-19 will provide that essential data in real-time.
Michael W. Fried, MD, FAASLD
The Coronavirus (COVID-19) pandemic has generated an urgent need to identify, test and validate novel diagnostic and therapeutic regimens for the treatment and prevention of the coronavirus. To date, there are no FDA-approved therapeutics to treat this disease and researchers are racing to develop treatments and vaccines to reduce the morbidity, mortality, and incidence of this disease. With no historical data available, scientists, healthcare providers and pharmaceutical companies are expected to face many challenges as they work in unprecedented and unknown territories.
There are several investigational agents being assessed for treatment of COVID-19. Phase 3 clinical trials for these therapies have been initiated at record speed and will be helpful in showing good measures of clinical efficacy. However, there is also a need to capture clinical characteristics, treatment modalities and clinical outcomes outside of these Phase 3 trials. Real-world evidence (RWE) is expected to play a significant role in supporting the approval of novel diagnostics and therapeutics by providing real-world data, contributing as a synthetic control arm, and potentially supporting the fulfillment of post-marketing requirements.
TARGET-COVID-19 is a longitudinal observational study of clinical characteristics, natural history, treatment, and outcomes of hospitalized patients with COVID-19. This study was launched to capture data points in the real-world setting. The platform can help offer insights into the disease progression, clinical characteristics, treatments, and patient outcomes in real-world settings. Additional COVID-19 dataset comprised of hospital codes and billing information is available on inpatients and outpatients, which provides further disease insight.