NEWS

Standardization, More Funds On Horizon for Clinical Trials

Caroline McNeil

Standardized, electronic case report forms and budgeted funds for correlative science studies are two changes that may be on the horizon for oncologists who take part in federally funded clinical trials, according to recommendations from the National Cancer Institute's Clinical Trials Working Group (CTWG). These and 19 other draft recommendations, unanimously accepted by the National Cancer Advisory Board (NCAB) on February 17, are part of a major effort to integrate the disparate and sometimes duplicative parts of the institute's clinical trials system (see News, Vol. 97, No. 2, p. 92, "Redesigning NCI's Clinical Trials System: Integration Is the Goal").

The recommendations emphasize standardized research tools, data sharing through central databases, more support for accrual efforts, increased involvement of community oncologists and patients, and certification programs for investigators, sites, and staff.

Two major recommendations call for the creation of permanent, central working groups—one for phase I and II trials and one for phase III trials. Made up of experts outside the NCI, these groups would coordinate all institute-sponsored and intramural trials, including those initiated through the cooperative groups, cancer centers, grants, and other NCI funding mechanisms.

The phase I–II group would work with the institute's Investigational Drug Branch on trials of products for which NCI holds the investigational new-drug application (IND). The phase III group would "leverage" the NCI cooperative groups' existing intergroup process. The intent is to broaden that process to include other funding mechanisms, according to James Doroshow, M.D., director of NCI's Division of Cancer Treatment and Diagnosis, who chaired the CTWG.



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James Doroshow

 
Still, the recommendation that may have the largest impact on trialists is one that calls for the development of standardized case report forms. This is the "single most important thing we can do" to improve efficiency, Doroshow said.

Although the forms could never be completely uniform because of the different requirements of different kinds of trials, most elements could be standardized, Doroshow said. "We're going for the 80% [that can be uniform], which would make a huge difference."

Rick Pazdur, M.D., director of the Division of Oncology Drug Products at the U.S. Food and Drug Administration, agreed that a core report form made sense for all trials, including those sponsored by industry. "I would be happy to work on this and to expedite this," he said.

Standardization is the theme of several other recommendations, including a call for uniform language in clinical research contracts that address issues such as intellectual property and publication rights. "One of the greatest delays in initiating clinical trials relates to coming to agreement on intellectual property and ... some of the financial aspects of the conduct of clinical trials," said David Parkinson, M.D., a vice president at Amgen in Thousand Oaks, Calif., who co-chaired the CTWG Standardization and Infrastructure Subcommittee. "There's no reason the language has to be as diverse as it currently is."

Last fall, CTWG members considered the need to establish core research services, such as correlative science laboratories and biostatistical resources, but a survey changed their minds. "Nobody felt that the resources did not exist," said Frederick Appelbaum, M.D., director of clinical research at the Fred Hutchinson Cancer Research Center in Seattle, who chaired the Core Research Services Subcommittee. Respondents to the subcommittee's survey said that core resources do exist in cancer centers and elsewhere—the problem is finding the funds to access them.

As a result, the subcommittee recommends that NCI establish annual budgets for ancillary studies, including correlative science, health economics, and quality-of-life investigations. Investigators would request the funds on a protocol-by-protocol basis. The next step will be to "to figure out ways to certify core services as being up to snuff," and how to review requests quickly and fairly, Appelbaum said.

Several other recommendations call for more funding for specific activities. For example, the Patient Accrual Subcommittee recommends funding both for required site personnel and for community outreach to recruit a diverse patient population.

This subcommittee also recommends expanding the use of community-based regional institutional review boards (IRBs). Typically located in a large hospital, these boards serve as the IRB of record for other hospitals in a city or region. "This would in no way diminish the central IRB," said Richard Schilsky, M.D., associate dean for clinical research at the University of Chicago and chair of the accrual subcommittee. In fact, the regional IRBs could accept the reviews of the central IRB, making the process even more efficient, he said.

The CTWG recommendations are expected to include many more details and to be implementable by the time the NCAB meets in June. Many specifics—the ways to select trials for the new ancillary study funds, for instance—are now under active discussion.

All of the CTWG's draft recommendations are posted at http://integratedtrials.nci.nih.gov/ict/draft_recommendations along with an invitation for continued public comment.



             
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