The researchers want to conduct clinical trials in emergency departments, where large numbers of people infected with diseases such as the flu often go for care. The goal is to show that EDs can create opportunities to cut drug study time without threatening the built-in protections for trial volunteers imposed by the FDA’s drug approval process. They aim to launch a trial run at Johns Hopkins Hospital during the upcoming flu season.
“Normally you do trials in doctors’ offices or inpatient wards with 100 or 200 sites often needed over several seasons because each site may only enroll one to three people,” said Richard Rothman, MD, PhD, a professor of emergency medicine in the Johns Hopkins University School of Medicine who is co-leading the study, according to the report. “Here in the emergency department, a lot of people come in sick. That creates an opportunity.”
Typically, drugs go through several rounds of progressively larger clinical trials to ensure they are first safe, then effective, according to the report. The Hopkins researchers believe using EDs as a clinical trial setting could accelerate the process, especially for drugs that are further along in the route to approval.
In the study, Hopkins emergency room staff will evaluate patients for the flu regardless of their primary complaint. Patients with symptoms will be tested and screened using a process previously developed at Hopkins that has proved effective in identifying patients with the flu who could benefit from antivirals such as Tamiflu, according to the report. Test and screening results will be entered into EMRs, from which physicians will identify good study candidates. They will provide patients with all of the standard information about the drug’s risks and benefits, and patients who can benefit from the drugs will get them whether or not they participate in the study. Those who volunteer for the study will be followed by researchers for two weeks and provided with follow-up care if necessary, according to the report.
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