Author: Eva Pastor
Date: 08-29-09 12:59
Source: newsobserver.com
URL: http://www.newsobserver.com/opinion/columns/story/1663269.html
Date published: August 29th 2009
Getting clinical trials on track
BY SUSANNE B. HAGA
Published: Thu, Aug. 27, 2009 02:00AM
DURHAM -- A recent New York Times article reported that lack of public participation in cancer clinical studies is hampering development of new drugs and interventions, with just 3 percent of adult cancer patients joining trials. Perhaps only half of cancer trials reach their recruitment goals, according to the article, and many fail to enroll even one research subject.
Cancer care may have come a long way in many regards since President Richard Nixon launched the war on cancer in the 1970s, but clearly we'd be much further if researchers could find a way to recruit enough participants to get meaningful results. And cancer studies are surely not alone, slowing the rate of medical progress as a whole.
It would be easy to simply get discouraged by these statistics, but they also point to something else: the vast opportunity we all have to help speed the pace of discovery.
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Take North Carolina, with our strong biomedical research presence. According to a federal database of clinical trials, almost 1,800 clinical studies -- some 700 focused on cancer -- are now recruiting patients from across the state. In total, those trials alone demand more than 1.8 million research subjects to meet their recruitment goals.
Those trials come in many different flavors. The most familiar type tests the safety and effectiveness of new drugs compared to standard treatments. But some trials enroll as many people who are healthy as they do ones who are sick. Some may involve testing of an intervention -- a drug, device, surgical procedure or behavioral change -- while others may simply involve observation. Some need only a handful of subjects; others call for thousands.
Regardless of the type of clinical trial, when too few patients are recruited, researchers have little option but to shut down a study, leaving critical research questions unanswered.
There may be many, perfectly legitimate reasons why people don't enroll -- no personal benefit, no time, potential harm, mistrust of the medical community, financial uncertainty and so on -- and the onus is no doubt on the researchers. But given the broad range of studies seeking research participants, and in their actual risks and requirements, many of us could likely find a way to contribute without necessarily extending ourselves too far beyond our comfort zones.
After all, studies requiring a 15-minute quality-of-life survey after surgery are a lot less daunting to consider than a test of a new cancer drug that might require, say, 10 visits to a clinic 50 miles from your home in a month.
Other players must do their part too. Scientists and physicians can help improve recruitment rates by designing clinical trials that are more consumer or patient-friendly, such as providing more flexibility, requiring fewer visits if possible or collecting data online, by phone or even via in-home approaches. Financial or other incentives for referring physicians and for patients might also hold sway.
The standard design of clinical trials itself might need revision, which would also mean that regulatory authorities would have to reconsider what constitutes acceptable evidence. It may sometimes be that the best trial design from a scientific perspective is also the one least likely to reach its enrollment goals. Any costs that come with the needed change would seem to pale in comparison to the money, time and vast potential lost in trials that never reach completion.
Billions of dollars, many of them federal tax dollars, are spent on clinical research each year. The recent federal stimulus package allocated $200 million to clinical research studies to compare the effectiveness of drugs or other medical interventions and give doctors the data they need to provide their patients -- all of us -- with the best care based on the evidence.
So, the next time you hear an advertisement on the radio or read a flier at the doctor's office, please take an extra minute or two to consider whether you might be willing and able to help turn those dollars into a real difference.
Susanne B. Haga, Ph.D., is an assistant research professor in the Institute for Genome Sciences & Policy and the Sanford School of Public Policy at Duke University. More information about clinical trials is at www.clinicaltrials.gov, a federal database of clinical trials, or www.cc.nih.gov/participate/studies.shtml for general information about clinical trials, both maintained by the U.S. National Institutes of Health.
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