Effort grows to teach risks, benefits of clinical trials

Programs help volunteers make informed choices

June 09, 2005|By Julie Bell | Julie Bell,SUN STAFF

Tamir Orbach had just learned that he had a potentially fatal bone marrow disease when he had to grapple with an extraordinarily difficult choice.

Should he have the standard treatment - a bone-marrow transplant with high-dose chemotherapy and radiation, which could cause life-threatening complications itself? Or should he choose a transplant and an experimental, lower-dose treatment that might be easier on his body but was unproven?

"I was terrified," said Orbach, 31, of Gaithersburg, who was told last year that he had an aggressive case of a rare bone-marrow disease known as PNH.

Like Orbach, patients and their families are often overwrought when they are asked to consider participating in a clinical trial. Weighing the potential risks and benefits is even more difficult when in an emotional fog.

But recently, a small, yet growing number of clinical research programs have been making efforts to better educate patients and the public about the risks and benefits of participating in trials - the human tests of drugs and medical devices for which millions of people volunteer annually.

Those who run clinical trials acknowledge that the motivations for patient and public education go beyond wanting to do the right thing. They are also a response to fear of lawsuits, pressure from insurers, the desire to appear competitive to drug companies in search of clinical trial sites, and concern over a dip in public trust in the wake of research deaths.

"Anybody who's in the field understands ... that there has been some erosion of public trust as a result of some of the problems," said Susan Buskirk, executive director of the University of Maryland School of Medicine human research protections program.

Aurora Health Care in Milwaukee recently held a forum to explain clinical trials to the public. A National Institutes of Health grant pays for a clinical trials educator at a nonprofit that helps bone-marrow disease patients. And organizations such as Dallas-based Baylor Research Institute, which oversees clinical trials in at least 13 institutions, and the University of Maryland medical school have developed brochures and are planning improved Web sites to help potential enrollees examine their options. The Johns Hopkins University is deciding how to expand education, as well.

An increasing number of academic medical centers and private clinical trials oversight boards are seeking accreditation. They hope that will increase both their efficiency and the public's trust - helping them attract more trials and patients. The two organizations that offer such accreditation - the Partnership for Human Research Protection and the Association for the Accreditation of Human Research Protection Programs - require efforts to educate those who might enroll.

Potential conflicts

The U.S. Food and Drug Administration requires clinical trials - a series of tests in humans - to show the safety and effectiveness of drugs and medical devices before they are marketed. Without them, medical advances would grind to a halt.

But trials are also big business that can lead to conflicts of interest. Drug company sponsors pay institutions that serve as hosts for trials; scientific breakthroughs can bring fame and fortune to physician researchers; and medical centers compete for trials to be at the forefront of cutting-edge medicine and the money that comes with it.

Alan C. Milstein, a Philadelphia-area attorney who represents clients harmed in research experiments, said accreditation will do little to improve safety, no matter how many questions the subjects learn to ask.

"There's so much research going on, the money is so big, that I don't believe this is a measure that solves the problems that exist," Milstein said.

Worldwide, about 50,000 clinical trials were under way in 2003, with 35,000 in the United States, according to CenterWatch, a Boston-based unit of the Thomson Corp. Up to 3.5 million people are enrolled in current U.S. trials, the group estimates.

Despite the large numbers, U.S. researchers have trouble recruiting patients for clinical trials. About 80 percent of trials are delayed at least a month partly because researchers can't find subjects fast enough, CenterWatch says.

The theory behind increased outreach is in part that patients who are knowledgeable about trials will be better able to weigh risks and benefits.

Patient education is also in order, advocates say, because clinical trials are overseen by a fragmented and understaffed federal oversight system.

The 38-person Office of Human Research Protection has jurisdiction over trials conducted or funded by the Health and Human Services Department. The FDA - with 276 U.S. clinical investigators in 2002, the most recent figure available - has oversight of any trial that spawns data submitted to put a drug or device on the market.

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