Magazine article Drug Topics

Patient Enrollment Rate Limiting Stroke Research

Magazine article Drug Topics

Patient Enrollment Rate Limiting Stroke Research

Article excerpt

More than 20 clinical trials are under way to evaluate either "clot-busting" or neuroprotective drugs in the treatment of stroke. That's the good news from the National Stroke Association (NSA).

The bad news, however, is that the clinical trials are moving along at a very slow pace. "For the first time, we have real promise of a true treatment for stroke," Gary Hauser, NSA v.p., said in an interview with Drug Topics. "The barriers are that people don't recognize the symptoms [of stroke] and therefore don't immediately call 911 or get emergency care. That's the primary reason stroke studies are moving ahead fairly slowly."

At some clinical study sites, Hauser said, patient recruitment has averaged less than one patient per site per month. It's not uncommon for patient enrollment to take two to three years to complete, Hauser said. In some cases, it's taken as long as five years.

"Stroke has never been treated as a medical emergency," Hauser explained. "The general public and at-risk individuals are generally not aware of the warning signs of stroke--they don't know the signs and symptoms." Hauser noted that people having a stroke delay taking action, and, on average, about 12 hours elapse between the time of onset of symptoms and the time patients seek medical help.

According to Hauser, close to 20 trials are either ongoing or about to be launched to evaluate pharmaceutical agents that can be used for immediate treatment. All of the investigational agents, he said, have to be given within six hours of onset of symptoms.

In an attempt to address the problem of delays in seeking medical treatment, and to speed patient recruitment into stroke trials, NSA, with the help of several pharmaceutical companies, is embarking on a major public awareness campaign. Through the Clinical Trial Acceleration Program (CTAP), NSA aims to change the public's fatalistic perception that nothing can be done about stroke, educate at-risk patients and the general public about the signs and symptoms of stroke, prioritize stroke as a medical emergency, enhance the efficiency of clinical study sites, and ultimately speed patient enrollment in clinical trials.

One component of CTAP is the Emergency Response System Organization at Site (ERSOS). Through this program, the NSA is working with emergency response teams to help them recognize the signs and symptoms of stroke and understand the need to prioritize stroke as an emergency. …

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