Advertising may be cost-effective, but liability lurks in the wording

IRBs looking for false promises and inducements

You can’t have a clinical trial without volunteers, and clinical trial coordinators and investigators often find that recruiting human subjects takes some creativity. Enter advertising.

Advertisements seeking participants for clinical trials can be found in newspapers, on radio, in brochures, on public transit billboards, on television, and on the Internet. They can be expensive, but they have proven to be effective. They also can be subtly coercive unless careful attention is paid to what is promised and what is not said, say institutional review board (IRB) administrators and those who work to ensure ethics in research.

"One thing [clinical trial advertisers] have to keep in mind is that advertising meant to recruit subjects can’t be used as a marketing tool," says W. Parker Nolen, MBA, IRB administrator for St. Joseph’s Hospital in Atlanta.

While it’s permissible for a drug approved by the Food and Drug Administration (FDA) to make certain claims about what it can do for the user, clinical trial recruitment ads must be carefully worded to make sure readers know that what is being advertised is research, not treatment, according to Department of Health and Human Services’ guidelines published by the Office of Inspector General (www.dhhs.gov/progorg/oei).

And the line between permissible information and coercive inducement extends to other benefits that might come with participation in a clinical trial, Nolen says.

"My experience is that one of the most common mistakes people make [in drawing up advertising for clinical trials] is in the wording that describes compensation," he says. "Saying, You can make $500!’ or You’ll get a DVD player!’ can cause the ad to be rejected [by the IRB]."

A research trial’s IRB determines whether advertising is acceptable or not, and Nolen says IRBs handle that task in a variety of ways. Sometimes the administrator reviews and approves or rejects the ad; in other situations, a committee does. He adds that federal regulations governing IRBs specify that the chairman or an experienced designated reviewer may review and approve advertising.

"Advertising and recruitment of subjects for research are considered an extension of the informed consent process," says Alisa Irwin, director of research protections, University of California-Irvine Office of Research Administration.

"Given that advertising often functions as the initial step in the informed consent process, the IRB must ensure all advertising includes a reasonable balance between the legitimate goal of recruitment and adequate disclosure about the nature of research," she adds. "Advertising must be clear that subjects are being recruited for research, be free of the potential to contribute to confusion between experimental research procedures and standard medical treatment, emphasize both the risks and benefits of participation, and disclose important features of the study design that may influence enrollment. All of these are expectations of federal regulations."

Advertisements need not include every potential risk and benefit, Nolen said, because that information is disclosed in the informed consent process prior to a subject being enrolled in a trial. However, the major known potential risks and benefits should be mentioned.

Irwin says a trial’s IRB should review all advertising with an eye toward avoiding the risk of undue inducement and social or therapeutic misconceptions (e.g., wording such as "groundbreaking treatment for advanced esophageal cancer" or "Suffer from debilitating headaches? A new treatment option now is available!")

Nolen adds that buzzwords such as "new and exciting," "cutting edge," or wording that indicates the trial is free treatment for a condition should be avoided.

Interesting aside

According to the FDA, research into recruitment advertising has indicated that expensive advertising is cost-effective only for studies in which the eligible population is large and widely dispersed (e.g., depression or heart disease), as opposed to rarer conditions such as cystic fibrosis. Internet advertising, Nolen adds, has been seen to attract "a more savvy and educated audience" than mass media advertising in some cases.

The FDA advises that the mode of advertising is an important consideration when a trial seeks to recruit subjects with acute or severe physical or mental illness, or when the audience may include persons who are economically or educationally disadvantaged.