Recruiting and enrolling patients in clinical trials is just one behind-the-scenes link in the complicated process that results in medications winning regulatory approval and the subsequent marketing to doctors. But like a lot of steps in that process, the clinical trial machinery is coming under scrutiny as questions arise over the extent to which doctors are compensated for their participation.

The issue has been the subject of an ongoing investigation by the Senate Finance Committee’s Chuck Grassley, who has probed undisclosed conflicts among various academic researchers who simultaneously receive industry and federal funding. And so the faculty at the Center for Health & Pharmaceutical Law & Policy at the Seton Hall Law School have issued a 62-page paper with some suggestions for greater oversight of the financial relationships with doctors.

For instance, they suggest the federal government should bar payments solely for a referral to a trial; payment tied to screening potential trial participants, and bonuses for recruiting or retaining a certain number of participants. Why? Payments might otherwise encourage enrollment of patients who don’t belong in a study or deemphasize info that might discourage someone from enrolling.

What else? Their report says the federal government should also prohibit compensation for research in the form of an equity interest in the sponsor of a clinical trial. And federal policy should specify certain conflicts, such as stock holdings, that will disqualify a researcher from serving as an investigator. And federal regs should require all other conflicts should be identified and managed.

Here are more suggestions from their paper: At the outset of a trial, institutions should “evaluate relationships between industry and physicians to determine if the magnitude and form of the individual’s financial interest with the sponsor, the longevity of the relationship, or other factors suggest that there is a conflict of interest requiring elimination, reduction, or management.”

“Investigators should be required to report all financial interests, irrespective of amount, to an institutional committee for review, rather than leaving it up to investigators to determine if the interest could reasonably be expected to affect the research. Institutions should also be required to establish internal databases that investigators must update as information changes about their financial relationships with for-profit entities.”

“Individual institutions should have the discretion to determine whether to create a special conflicts of interest committee to review and manage individual investigator conflicts or whether to delegate those responsibilities to the institutional review board.”

“For research conducted in academic medical centers, a board of directors committee, including members independent of management and the faculty, should oversee institutional conflicts in research. The committee oversight should extend beyond primary institutions, such as a medical school or university, to any not-for-profit institutes or for-profit corporate entities that are substantially controlled by or operate under the auspices of the medical school or university.”

“Review and management of investigator or institutional conflicts prior to the time that research begins should be mandated by regulation and subject to contemporaneous government oversight.”

“Federal regulations should charge IRBs with reviewing conflicts held by investigators and entities conducting research in community settings. Federal regs should provide clear guidance to IRBs about the nature and scope of info to review, standards for review, and alternatives for eliminating, minimizing, or managing a conflict, both for investigators and institutions.

“Federal regs should also spell out clearly the obligation of community-based physicians acting as investigators or institutions acting on their behalf to report information about compensation for research and other financial interests to IRBs.”

“Federal law should require disclosure of payments for conducting trials and other relevant financial interests. Before research begins, research sponsors should report to the FDA and recipients of federal grants should report to the granting federal agency relevant equity and ownership interests as well as all payments…to the investigator and the investigator’s institution or practice group by the company whose product is under review in the clinical trial.”

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