A new asthma study will leverage real-time data in the next 10 years.
Michael E. Wechsler, MD
A 10-year, 10,000 patient asthma study could yield new drug and treatment plans, identify new patient comorbidities, understand the phenotypic characteristics of patients, and learn more about the pathophysiology of asthma over time.
Michael E. Wechsler, MD, a professor of medicine and a pulmonologist at National Jewish Health, and steering committee chair of the TARGET-ASTHMA study, said in an interview with HCPLive® the expansive study seeks to leverage ongoing, real-world patient data to better understand every aspect of asthma treatment.
“It's going to be a rapidly evolving field as we accumulate more and more data,” Wechsler said. “We'll get to learn more about the underlying disease and get a sense of the full spectrum of the disease. A lot of the data that we base our clinical decisions are based on clinical trial data and clinical trial data doesn’t provide all the answers for clinicians.”
Wechsler was set to appear at the during the American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Annual Meeting in Philadelphia, PA to advocate for the study, but the conference was ultimately cancelled due to the ongoing coronavirus (COVID-19) outbreak.
Investigators in the study will seek to capture additional respiratory diseases in the future, extending 3 years retrospectively prior to patient consent and 10 years prospectively.
One of the main goals of the study is to utilize medical record information with the patient’s consent. Wechsler explained that the investigators will collect both structured and unstructured medical data from the community sites, as well as on the academic side.
“We're going to build a base, which we'll be able to integrate, and we'll be able to measure the outcomes,” he said. “Hopefully we'll also be able to, at some point, collect some biorepository samples as well and try to connect the outcomes to the same metric.”
Wechsler said a main problem with clinical trials is they often exclude patients with comorbidities. He said this can skew the real-world data as a clinical trial may not include a smoker, for example, but there are many smokers who have asthma and need treatment.
Clinical trials may also overrepresent a given race or ethnicity and Wechsler said the study will seek to identify underserved patient populations.
The TARGET-ASTHMA study just launched recently, with the first patients enrolled only a few weeks ago. Wechsler said the goal is 10,000 patients at over 100 sites.
The asthma study is the 7th study in a series of Target PharmaSolutions studies looking at a number of diseases, including NASH, hepatocellular carcinoma, inflammatory bowel disease (IBD), primary biliary cholangitis (PBC), immune-mediated inflammatory skin conditions (DERM), and chronic hepatitis B (HBV).
“All of these studies that are done by Target PharmaSolutions are basically studies to capture data of diseases in the real world is across multiple populations,” Wechsler said. “It's basically a platform that allows us to get information on specific disease in the real world and to evaluate the efficacy of therapies as they're come out onto the market is different populations.”
The studies not only take a snapshot of the state of disease but also evaluate different treatments over time. These studies also give investigators the ability to cross analyze different patient populations and identify commonalities.