Clinical trials are suffering
Clinical trials are essential to medical progress -- they’re the only way of testing whether new drugs, surgical techniques or experimental devices actually work. But researchers are finding it increasingly difficult to find volunteers. A new study illuminates part of the problem. Americans are deeply suspicious of medical research, it found, and don’t trust their doctors to protect them from unnecessary risks when prescribing treatment.
“This is really an indictment of medical research,” said Dr. Giselle Corbie-Smith, co-author of the study published last week in the Archives of Internal Medicine. “If individuals distrust the research enterprise and are unwilling to participate in it, it could impede patient recruitment for clinical trials.”
Such distrust could also keep advanced, if unproved, treatments from the very patients who need them most.
Although researchers have always had problems recruiting patients, they say the problem has worsened. In 2001, 86% of all clinical trials didn’t meet enrollment goals, causing delays of up to a year, up from 80% in 1999.
“People thinking they are guinea pigs is just one element of a larger picture,” said Diana L. Anderson, president of a patient recruitment company in Dallas, Texas.
The sheer magnitude of the number of trials is one component. Last year, more than 6,000 new therapies, including drugs, procedures and devices, were tested in 80,000 locations around the country, according to CenterWatch, a Boston-based patient information group that monitors the clinical trial industry.
Another reason for the recruitment problems is that some treatments being tested are for relatively rare disorders, so there’s a limited pool of patients to draw upon. And last, eligibility requirements for some clinical trials are so strict that few people qualify. For tests of some experimental cancer therapies, for example, volunteers must be terminal and have failed standard therapy. Yet they can’t be too sick -- otherwise they won’t respond to the treatment.
Still, distrust plays a significant role, according to last week’s study. Although it has been known that large numbers of African Americans are suspicious of medical research, researchers were surprised to find skepticism among whites too.
Almost four out of five African Americans and more than half of whites believe that people could be used as “guinea pigs” for research without their consent. Many respondents -- 63% of African Americans and 38% of whites -- believed their doctors often prescribe medication as a way of experimenting on people without their knowledge or consent, and almost half of African Americans and more than a third of whites felt their doctors sometimes exposed them to unnecessary risks when deciding their treatments.
“We expected to see differences, but we didn’t expect to see such high levels of distrust across the board,” said Corbie-Smith, an assistant professor of medicine at the University of North Carolina, Chapel Hill.
These negative attitudes could ultimately derail medical advances. New drugs and medical devices must prove that they are safe and effective before they can be approved for use in the United States. The U.S. Food and Drug Administration requires that these treatments be thoroughly tested in extensive clinical trials, which often encompass thousands of people.
Consequently, without patient participation in these studies, “there would be no new products coming out,” said Ken Getz, chief executive of CenterWatch.
Experts say this lack of public trust is a legacy of medical research’s checkered history. In the 1950s and ‘60s, for instance, prison inmates and terminally ill patients were injected with live cancer cells, and U.S. Army soldiers were given LSD without their knowledge.
The most infamous of these incidents was the syphilis experiment started in the 1930s at Alabama’s Tuskegee Institute, accounting for much of African Americans’ lingering distrust of medical research. For more than 40 years, treatment was withheld from 400 syphilis-infected African Americans, who were never told what they had, so doctors could watch the natural progression of the disease.
In recent years, Americans’ confidence has been further undermined by the highly publicized deaths of two relatively healthy volunteers in studies at Johns Hopkins University in Baltimore and the University of Pennsylvania. In a 2001 survey conducted by the Assn. of Clinical Research Professionals in Washington, D.C., about 40% of their members said it had become more difficult to enroll patients because of the media attention over these and other problems with clinical trials.
“Research institutions have abused the great reservoir they have of goodwill among the American people,” said Adil Shamoo, a bioethicist at the University of Maryland School of Medicine in Baltimore and co-founder of the advocacy organization Citizens for Responsible Care and Research.
Yet federal data indicate it’s rare for people to die of negligence or poor care in clinical trials, and only 1 in 10,000 patients has died of the effects of drugs being studied. The lesson here, said Mark Eisenach, chief executive of Acurian, a clinical trials company in Philadelphia, “is that we’re not doing enough to explain how medical research works, and the benefits and rewards of that participation.”
Volunteers in clinical trials normally receive state-of-the-art care from physicians considered leaders in their field. For people suffering from terminal illness, these tests may be their last chance, and the experimental therapy may spare or lengthen their lives. Given these misgivings, however, people thinking about volunteering for a clinical trial “need to educate themselves so they feel comfortable about the process,” said Getz.
Consumers can get information from www.clinicaltrials .gov, a Web site sponsored by the federal government, and the American Assn. of Health Plans (www.aahp.org).
