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Clinical trials' worth is emphasized 
Web Posted: 07/13/2004 12:00 AM CDT 

Nicole Foy
Express-News Medical Writer 

The human brain is wired to keep its secrets well. Its physiology — that tangled web of nerve cells — has kept probing scientists at bay for years, and only recently has it begun yielding clues into its hidden world. 

But even as the mind slowly surrenders, the field of neurology is at a crossroad. 

Many medical researchers eager to find new treatments for debilitating conditions such as Alzheimer's and Parkinson's diseases say they're finding it difficult to recruit people into clinical trials. 

Clinical trials are the experiments that evaluate the safety and effectiveness of potential new treatments. And without the information they produce, the way the mind works — especially in the context of the diseases that affect it — would remain largely a mystery, said Dr. Robin Brey, a professor of neurology at the University of Texas Health Science Center. 

"The public needs to understand that there's no way we can further medical knowledge and the development of new therapies without clinical trials," she said. 

Brey is part of a new national effort by the American Academy of Neurology to promote the importance of clinical trials. 

As editor of a patient-focused column in the academy's medical journal, Neurology, Brey helps communicate complex information to a lay audience hungry for details of new treatments. 

This month, both the journal and Brey's "Patient Page" are dedicated to clinical research. 

The journal is introducing a new Clinical Trials Recruiting Section where trials will be listed in a single section instead of throughout the publication. 

The edition also details the challenges of clinical trial recruiting, as well as success stories from earlier studies. 

One of those stories surrounds the development of a drug known as tPA, or tissue plasminogen activator. The treatment breaks up blood clots, the main cause of stroke. 

The drug was in the development stages for years, followed by exhaustive clinical trials that helped determine its appropriate use, said Dr. John Marler, associate director for clinical trials for the National Institute of Neurological Disorders and Stroke. 

The human tests demonstrated a crucial, yet narrow time window of up to three hours after a stroke during which tPA can be administered in a hospital setting to reduce permanent disability. They also showed that someone having a stroke caused by bleeding in the brain should not be given tPA because it could increase the hemorrhaging. 

Clinical trials can be rigorous and slow, Marler acknowledged. Those with reservations about entering them often say they don't want to be treated as "guinea pigs" or face the possibility of receiving a placebo instead of the treatment, he said. 

But neurology isn't the only medical specialty facing challenges in recruiting patients. 

In an editorial, Marler cited statistics estimating that 80 percent of clinical trials have problems in recruiting that delay or prevent their completion. 

For more information, go to http://www.neurology.org. 



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