By Deborah Borfitz

March 6, 2008 | When it comes to patient recruitment and retention strategies, institutional review boards (IRBs) often find themselves in the blind spots of drug companies looking to complete studies as quickly as possible with an adequate supply of volunteers. The role of IRBs is strictly to protect the rights and welfare of clinical trial volunteers. Since recruitment practices and advertisements for volunteers represent the beginning of the informed consent process, they cannot be coercive, says James Saunders, MBA, vice president of New England IRB (NEIRB).

Not all recruitment plans are up to the subjective snuff of reviewers at NEIRB. Several problematic issues tend to emerge repeatedly, says Saunders. These include “overly aggressive” compensation and marketing campaigns.

“We like to avoid the situation where subjects get paid so much they might agree to participate against their better judgment,” says Saunders. In Phase II and III studies, “money is not really the only motivation to participate. Subjects might receive a medical exam at no charge, for example, so there’s…potential benefit for them.”

Non-coercive compensation being difficult to quantify, IRBs generally apply the logic that subjects be paid based on some reasonable calculation of the time and effort they devote to the trial, says Saunders. Reviewers also frown on “balloon payments” at the end of trials to induce subject retention. NEIRB has been approached in the past with compensation plans that make the entire payment contingent on completion of the study. In cases like this, its recommendation is that payments be prorated over study milestones, such as study visits.

Another big challenge for IRBs relates to recruitment plans where the study staff at research sites is paid a “headhunter-like” bonus for bringing in subjects over a certain goal, says Saunders. Consciously or subconsciously, more pressure is apt to be put on potential candidates to participate once the enrollment target is met, especially if a $500 bonus or a trip to Florida is on the line.

One clinical research organization asked NEIRB to approve an arrangement by which site coordinators would be offered a substantial cash bonus for recruiting study subjects. NEIRB worked out a compromise with the sponsor. In lieu of a cash bonus, site staff was offered the opportunity to gain credits for courses from a provider that specializes in clinical trial training.

In the realm of advertising for study subjects, NEIRB often sees some “fairly questionable” terminology that might make some people fall into the “therapeutic misconception trap,” says Saunders. “They think the drug is approved for whatever disease state they’re in, not that this is a clinical trial in which they’ll get a test article or maybe a placebo.”

Ads can cross the line in a variety of creative ways, “not necessarily intentionally,” says Saunders. For example, ads might say: “Have diabetes? We can help!” Other ads err by overemphasizing compensation while underemphasizing trial-related risk.

In a typical large, multi-site trial, a central IRB oversees 60 to 70 percent of investigators, says Saunders. The remaining investigators are under the watch of individual, institutionally based IRBs that may interpret federal regulation and guidance on human subject protection differently.

Differences of opinion can emerge over some seemingly minor interpretative points, such as the imperative of using the term “study drug” rather than simply “drug.” Disagreements are unlikely to result in a lapse in patient protection, says Saunders. “But it can be a bit of a logistical issue for sponsors to manage and balance the different IRB processes that go on for different investigators.”
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