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Federal Oversight of Clinical Trials Needs to be Simplified to Increase Effectiveness

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Duke Health News 919-660-1306

DURHAM, N.C. -- The top two officials at the Duke University Medical Center say clinical research has the ability to transform medicine and reduce medical errors, but must focus on developing the best ways to assure the protection of human subjects.

Medical researchers, and the government agencies that watch over them, agree that protection of people who participate in clinical trials is a top priority, but Dr. Ralph Snyderman, the Duke chancellor for health affairs, and Dr. Edward Holmes, dean of the Duke School of Medicine, suggest that the government's oversight mechanism can be streamlined for the benefit of all.

In a policy forum article published in the Jan. 28 issue of the journal Science, Snyderman and Holmes recommend that the government's multiple human protection oversight responsibilities be centralized into a single office, and that the regulations now on the books should be reviewed and overhauled.

"We endorse oversight mechanisms that protect research subjects to the maximum degree possible," Snyderman and Holmes say in the article. "Nonetheless, it is our view that regulatory and compliance mechanisms are overly complex, difficult to interpret and, at times, redundant.

"Given the expansion of clinical research, it is time for a comprehensive review of subject protection legislation and oversight that was developed in a far different era," they say. "The goal should be an effective, simplified system that is understandable, that works, and that is adaptable to change."

The suggestions come from experience. For four days last May, the federal Office of Protection from Research Risks (OPRR) suspended Duke's ability to enroll participants in ongoing clinical trials pending action to improve administrative procedures that govern the review of research involving human subjects.

Snyderman and Holmes contend that "increasingly complex and costly oversight mechanisms" can impede the ability of researchers to conduct clinical investigations. That's because uniform standards for patient protection have not been overhauled for several decades, during which time clinical research has undergone "explosive growth," they say. A system that worked in 1974, when 400 research protocols at Duke were examined by its Institutional Review Board (IRB), the OPRR and, in some cases, the Food and Drug Administration, is not necessarily the best for today, when, for example at Duke, about 2,200 protocols are reviewed annually.

But there are ways to streamline the system, making it efficient and therefore, more effective, Snyderman and Holmes say. Their recommendations include:

A comprehensive and broadly based review of federal regulations to protect human subjects with the goal of creating a single set of effective regulations. For example, the current system usually requires an institution's IRB to review all grants that will be submitted for federal funding. Yet, less than one-third of all grants will be funded. That means, Snyderman and Holmes say, the IRB reviewed two-thirds of the submitted grants for no useful purpose. Not only do the IRBs have to review the research protocols, federal regulations require that committee members review the entire NIH grant, including the budget. Snyderman and Holmes say this process could be streamlined to allow an initial screen of submitted proposals with comprehensive reviews of those expected to receive necessary funding.

That oversight for all clinical research subject protection be delegated to a single federal agency with a single reporting mechanism, regardless of the funding source. Multiple oversight agencies and lines of reporting - including OPRR, FDA and the funding agency - "can create duplication and ambiguity," Snyderman and Holmes say. "For example, a multi-institutional clinical trial funded by NASA is regulated by the IRB at each participating institution, by NASA, and by OPRR. If a problem occurred that led to an OPRR audit of a particular institution, the FDA would conduct an additional audit of that institution," they write. "Conversely, if the FDA audited an institution for a problem, OPRR would be notified and would conduct their own audit of all DHHS-funded studies." A single federal agency should be adequately funded so that it could work in collaboration with institutions and physician practices to establish a system of prospective review, accreditation, and continuing education to reduce the need for retroactive review, they say.

That a mechanism be established for entities to obtain prospective approval for standard operating procedures. Because "well meaning individuals and institutions may interpret regulations differently," regulatory agencies should provide examples of the how institutions can meet the required regulations, Snyderman and Holmes say.

Consideration of ongoing certification of IRB members and clinical investigators and accreditation of institutions. Institutions and investigators have varying levels of understanding of current clinical research regulations and procedures, Snyderman and Holmes say. Certification by a federal entity or an impartial private entity could ensure adequate understanding of federal regulations, ethical issues in clinical research, and the organizational structure needed to document compliance.

That infrastructure costs for human subject protection be negotiated and built into the indirect cost recovery for both federal and privately funded research. Increases in clinical research, oversight, and other regulatory mechanisms have required financially strapped medical schools and teaching hospitals to fund an increasingly large infrastructure, Snyderman and Holmes say.

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