The commercial pressures to hasten clinical trial enrollment could be ripe for legislative attention in the context of consideration of bills to improve IRBs.

House Government Reform/Human Resources Subcommittee Chair John Mica (R-Fla.) plans to convene at least one hearing this summer to discuss legislation to reform the institutional review board process.

The hearing likely would involve discussion of the latest HHS Inspector General report on the IRB process, which focuses on human subject recruitment (¹ Also see "FDA Clinical Site Inspections Should Look At Recruitment Tactics - IG Report" - Pink Sheet, 19 June, 2000.). The report, released June 12, is a follow-up to a 1998 IG study.

Mica plans to schedule a hearing to discuss Rep. Diana DeGette's (D-Colo.) "Human Research Subjects Protection Act" (HR 4605). Mica is a co-sponsor of the bill, along with Reps. Henry Waxman (D-Calif.), John Dingell (D-Mich.), Edolphus Towns (D-N.Y.), Pete Stark (D-Calif.), Dennis Kucinich (D-Ohio) and Steve LaTourette (R-Ohio). The bill was introduced June 8.

The DeGette bill would implement many of the recommendations included in the IG report. The measure would authorize full funding for human subject protection compliance through research grants, set standards for IRB membership and attempt to prevent IRB "shopping" by requiring investigators to disclose any prior rejections of a study protocol.

However, a prominent theme in the IG report is the perception that efforts by sponsors to accelerate clinical development schedules may be leading to overly aggressive trial recruitment strategies.

"Recent changes in the research environment are causing sponsors to vie more aggressively to be the first to bring their product to market and are causing sites and investigators to compete more intensely for research contracts," the report says.

IG cites pressure for quick turnaround times based on the cost and duration of clinical trials, a more intensified need for study subjects with more drugs in development and average trial sizes increasing, and a quest for more efficiency by research sites.

The report lists four strategies employed in recruitment: incentives to investigators who achieve high enrollment, investigators targeting their own patients, use of referrals and advertising.

IG maintains IRB officials "and others closely involved with clinical research" have "many concerns about current recruitment practices."

The document does not directly address the appropriateness of recruitment practices, instead emphasizing the need for greater understanding by IRBs of the extent of their authority to reject practices. However, a number of the examples in the report are likely to provide ammunition for critics of private-sector recruitment practices.

Public Citizen's Health Research Group, in comments on a draft version of the report, focused on the rise of contract research organizations as an explanation for the clinical trial recruitment pressures.

"Because human experimentation has been transformed to a 'business model,' this newly emerging 'business' of experimenting on people has every imaginable incentive for fast recruitment and fast results," HRG declared.

HRG suggested an alternative regulatory agenda: "banning finder's fees; banning reimbursement to physicians beyond research-related expenses and time expended; mandatory disclosure to the potential participant of the source and amount of all recruitment fees; and restrictions on the ability of health care providers other than the patient's physician from gaining access to a patient's medical records for the purpose of recruitment."

The Pharmaceutical Research & Manufacturers of America, in April 12 comments on the draft version, expressed concern "that the report is anecdotal and contains a number of false or overly simplistic statements. And, overall, it displays a certain degree of naivete about the subject being discussed."

The report recommends FDA and the National Institutes of Health "facilitate development of guidelines for all parties on appropriate recruiting practices." FDA and NIH have been working with the Public Responsibility in Medicine & Research group on development of IRB standards.

The IG report focuses on industry-sponsored research. "We are focusing on this research because the financial incentives to create effective and competitive drugs profitably are more pronounced in industry-sponsored research than in research funded by the government," IG explains. "We are aware that government-funded research is not immune to these and other pressures; therefore we may follow up later by focusing on recruitment in government-sponsored trials."

IG Clinical Trial Report Stresses Commercial Pressure To Speed Enrollment

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