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STRATEGIC INSIGHTS

Sponsors are turning to large employers for help with large trials

BY JOHN OTROMPKE

January 15, 2005 | With hundreds of new therapeutic agents in the pipeline, it is no wonder that clinical trials sponsors are looking to organize trials around the workplace.

"There are too few adults in clinical trials, especially in the field of cancer," says Jed Weissberg, director of medical research for Kaiser Permanente, which recruited employees for the STAR trial of two anti-breast cancer agents. Noting that the situation is far different in pediatric oncology trials, where by far the majority of patients participate, and where results are also much better, Weissberg says, "In pediatric oncology, the field is so specialized, and there are so few oncologists, that they have a very strong network because they've put in the infrastructure to ensure that we learn from the treatment of every child."

Kaiser recruited patients for the STAR trial by sending information to members in its health plan. "We didn't explicitly go to Boeing and Lockheed and say, 'We want you to put the information on your Web site.'" Kaiser mailed information on the trial to its membership. "We also sent ads and marketing materials out to all of our own employees, because the vast majority of Kaiser employees are also our health plan members," said Weissberg.

In contrast, nearly 140,000 salaried, female GM employees age 35 and older received letters from Marcus G. Wilson, corporate medical director, informing them of the STAR trial and inviting them to be evaluated for possible participation. "We estimate that over 150,000 GM employees, retirees, and their family members were treated for cancer last year. That's nearly 18 percent of the 1.2 million people covered by GM healthcare plans — an enormous figure," Wilson says.


Hidden Gotchas 
"There are no restrictions on how recruitment is achieved," explains Sharona Hoffman, a professor of law at Case Western Reserve University and a member of the institutional review board (IRB) at Metropolitan Health Hospital, which is associated with the university. "A lot of times people will advertise clinical trials in a hospital and maybe get the hospital employees or university students involved. It can be appropriate or it can also be a source of undue coercion, depending on whether any pressure is placed on those being recruited," Hoffman says.

STAR Trial Hits Its Numbers 
Last June, the National Surgical Adjuvant Breast and Bowel Project (NSABBP) reached an important milestone.

Read More 
  
But if a clinical trial is a source of complaints to the FDA, which in many cases has to issue permission to test a new, unapproved drug on human populations, the agency may well take into account recruitment methods, Hoffman says. "They can stop the clinical trial, discipline the investigator, or just require some change in procedure. They should be taking every complaint seriously. But its like any other offense- if you don't get caught, you get away with it."

While recruiting via employers may be growing into a new norm, investigators have to be cautious, Hoffman emphasizes, because the principles of informed consent may be jeopardized if payments to participants grow so large as to constitute an "undue inducement," or if other coercive circumstances are present, she says.

"I think a fair number of employees do participate, because they might get medication free or if they can make a little money," Hoffman says. "But at the IRB I'm a member of, we require investigators to place a notice saying that if the employee chooses not to participate, that's no problem — really emphasizing that it's a completely voluntary choice for them."

The concern may arise whether the recruiter is a drug manufacturer or some other healthcare provider. As one analyst wrote, "[E]mployee research programs raise the possibility that the decision will affect performance evaluations or job advancement. It may also be difficult to maintain the confidentiality of personal medical information or research data when the subjects are also employees, particularly when the employer is also a medical institution." In some cases, FDA rules and regulations may even require employee representation on the IRB itself, or may prohibit voting participation by employer representatives.


Silent Rules, Hidden Potential? 
Some of these reasons for caution were not lost on the companies participating in the STAR trial. "The IRB issue was separate for us," says Lori Garvey of the National Surgical Adjuvant Breast and Bowel Project (NSABBP). After we had captured the interest of the company, they cleared it through their own legal channels. This included whatever materials we gave them for risk assessment, which had been cleared through our own IRB," Garvey said, noting that NSABP uses the University of Pittsburgh's board. "But the biggest challenge was getting lawyers within the companies not to be afraid of lawsuits," she says.

For the time being, however, FDA regulations are otherwise literally silent on recruiting patients through employers. While recent FDA guidances have addressed the propriety of outright payments for referrals, (see "DHHS Draft Interim Guidance, Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators and IRBs to Consider When Dealing with Issues of Financial Interests and Human Subject Protection" at http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finguid.htm).

Trial sponsors and recruiters should also reflect on the fact that while the FDA's rules may consider the propriety of some practices that are not outright prohibited, a balancing test is recommended. Consider, for example, the rules governing conflicts of interest by investigators, which point out that "[s]tudy designs that utilize such approaches as multiple investigators ... blinding, objective endpoints, or measurement of endpoints by someone other than the investigator may adequately protect against any bias created by a disclosable financial interest." (See 21 CFR 54.5(b).)

Strategic Insights:
Because this trend is somewhat new, and may soon be practiced on an unprecedented scale, employers should proceed slowly at first. They might want to emphasize the potential medical benefits of trials. In the field of breast cancer, for example, results have been especially encouraging. According to Lori Garvey, while one out of eight women will develop breast cancer, "we're up to 95 percent to 97 percent disease-free five-year survival when the disease is caught early, in stages 1 or 2." In the first NSABBP study, which tested the effects of tamoxifene on breast cancer prevention, the results indicated that treatment reduced the risk of the disease occurring by 49 percent."

Recruiters should approach employers methodically with this information, and then proceed with caution. "This whole idea is very new to employers," Garvey says. "You have to try a lot of different strategies when trying to get these kinds of enrollment numbers. But if they have too much anxiety, it's really not worth pursuing. Really, its quite a progressive idea."

John Otrompke is a freelance writer. 





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